Brussels, 03 February 2023
Interinstitutional files:
2022/0009 (COD)
WK 1141/2023 INIT
LIMITE
CORDROGUE
SAN
This is a paper intended for a specific community of recipients. Handling and
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WORKING DOCUMENT
From:
General Secretariat of the Council
To:
Horizontal Working Party on Drugs
Subject:
Proposal for a Regulation of the European Parliament and of the Council on the
European Union Drugs Agency
- Outcome of technical meetings
Delegations are informed that since the last HDG meeting the Presidency continued the negotiations with
the European Parliament and the Commission on the draft Regulation on the EU Drugs Agency.
The first technical meeting took place on 12 January 2023, where five topics and the respective positions
of the institutions were discussed: cooperation with the civil society, National Focal Points, fees to be
charged by the Agency and other budgetary aspects, organisation of the Agency, and New Psychoactive
Substances.
This was followed by informal technical meetings on 24, 25 and 26 January 2023 and on 1 February
2023, where Articles 1-12 and Articles 36-41 were discussed together with two recitals relating to
budgetary provisions. Delegations will find the outcome of these meetings in the enclosed table in
columns 4 and 5, containing compromise proposals and comments. The lines highlighted in green are
considered provisionally agreed.
Delegations are invited to examine the lines highlighted in yellow and inform the Presidency by
13 February 2023 in case they have any substantial objections to the compromise proposals in
those lines together with arguments in favour or against, which would help the Presidency in the
upcoming negotiations.
WK 1141/2023 INIT
JAI.B RR/hm
LIMITE
EN
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the
European Union Drugs Agency
2022/0009(COD)
Outcome of informal meetings of 24-26/1/2023 and 1/2/2023
02-02-2023 at 09h16
Commission Proposal
EP Mandate
Council Mandate
Draft Agreement
Comments
Recital 29
(29) The Agency should be
(29) The Agency should be
(29) The Agency should be
(29) COM to propose a text
properly resourced to carry
properlyadequately
properly resourced to carry
of a declaration on the single
out its tasks and granted an
resourced to carry out
itsthe
out its tasks and granted an
budget line in the next MFF.
autonomous budget. It
tasks
, objectives and
autonomous budget. It
should be mainly financed
responsibilities assigned to
should be mainly financed
by a contribution from the
it under this Regulation.
by a contribution from the
general budget of the Union.
That should be properly
general budget of the Union.
The Union budgetary
reflected in the multiannual The Union budgetary
procedure should be
financial framework by
procedure should be
applicable as far as the
means of a dedicated and
applicable as far as the
Union contribution and any
ambitious and granted an
Union contribution and any
other subsidies chargeable to
autonomous budget.
ItThe
other subsidies chargeable to
the general budget of the
Agency should be mainly
the general budget of the
39
Union are concerned. The
financed by a contribution
Union are concerned. The
auditing of accounts should
from the general budget of
auditing of accounts should
be undertaken by the Court
the Union
with the
be undertaken by the Court
of Auditors of the European
necessary appropriations
of Auditors of the European
Union.
drawn exclusively from
Union.
unallocated margins under
the relevant heading of the
multiannual financial
framework or through the
mobilisation of the relevant
special instruments. The
Union budgetary procedure
should be applicable as far
as the Union contribution
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 1/95
Commission Proposal
EP Mandate
Council Mandate
Draft Agreement
Comments
and any other subsidies
chargeable to the general
budget of the Union are
concerned. The auditing of
accounts should be
undertaken by the Court of
Auditors of the European
Union.
Recital 30
(30) Fees improve the
(30) Fees
could improve the (30) Fees improve the
Informal COM suggestion:
funding of an agency and
funding of
anthe Agency
funding of an agency and
may be considered for
and may
, to the extent that
may be considered for
(30)
Fees improve the
specific issues that can be
such fees are duly justified
specific issues that can be
funding of an agency and
clearly separated from the
and necessary, be
clearly separated from the
may be considered for
core tasks of the agency.
considered for specific
core tasks of the Agency.
specific issues that can be
Any fees levied by the
issuesactivities that can be
Any fees levied by the
clearly separated from the
Agency should cover its
clearly separated from the
Agency should
The Agency
core tasks of the agency.
costs for providing the
core tasks of the agency.
should thus be empowered
The possibility for the
respective services.
AnyThe method by which
to levy fees, which should
Agency to deliver additional
fees levied by the Agency
be set out in a transparent
services, beyond its core
are calculated should be
manner and cover its costs
tasks laid down in the
40
transparent, and such fees
for providing the respective
Regulation, against
should cover
itsonly the
services.
payment of fees should be
Agency’s human and
introduced in order to
financial costs for providing
support Member States and
those non-core services. An
other stakeholders in
annual independent
understanding and
external audit, separate
addressing the drugs
from the annual audit
phenomenon. The method
undertaken by the Court of
by which fees levied by the
Auditors, which specifically
Agency are calculated
focuses on such fees should
should be transparent, and
be undertaken and
the Any fees levied by the
transmitted to the European
Agency should cover its the
Parliamentthe respective
full costs for providing
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 2/95
Commission Proposal
EP Mandate
Council Mandate
Draft Agreement
Comments
services.
respective the activities
related to the services
delivered, including staff
and operational costs.
When fees have been levied
in a financial year, the
Agency’s provisional
accounts should be
accompanied by a report on
those fees, which would also
be subject to the audit of the
Court of Auditors of the
European Union. Fees
should be set at a level that
avoids a deficit or a
significant accumulation of
surplus, and should be
revised when this is not the
case. ***
Alternative suggestions by
the Presidency, following
the consultation with the
Legal Service:
(30)
Fees improve the
funding of an agency and
may be considered for
specific issues that can be
clearly separated from the
core tasks of the agency. The possibility for the
Agency to deliver additional
services, beyond its core
tasks laid down in the
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 3/95
Commission Proposal
EP Mandate
Council Mandate
Draft Agreement
Comments
Regulation, against
payment of fees should be
introduced In order to
promote a coherent, Union-
wide approach and to
enhance the effectiveness of
the Agency’s work as well
as in order to support
Member States and other
stakeholders in
understanding and
addressing the drugs
phenomenon, it should be
possible for the Agency to
deliver, upon request,
additional services, beyond
its core tasks laid down in
the Regulation, against
payment of fees. The
method by which fees levied
by the Agency are
calculated should be
transparent, and the Any
fees levied by the Agency
should cover its the full
costs for providing
respective the activities
related to the services
delivered, including staff
and operational costs.
When fees have been levied
in a financial year, the
Agency’s provisional
accounts should be
accompanied by a report on
those fees, which would also
be subject to the audit of the
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 4/95
Commission Proposal
EP Mandate
Council Mandate
Draft Agreement
Comments
Court of Auditors of the
European Union. Fees
should be set at a level that
avoids a deficit or a
significant accumulation of
surplus, and should be
revised when this is not the
case.
Formula
HAVE ADOPTED THIS
HAVE ADOPTED THIS
HAVE ADOPTED THIS
48
REGULATION:
REGULATION:
REGULATION:
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 5/95
Articles 1-12
CHAPTER I
CHAPTER I
CHAPTER I
CHAPTER I
CHAPTER I
OBJECTIVES AND
OBJECTIVES AND
OBJECTIVES AND
OBJECTIVES AND
GENERAL TASKS OF
GENERAL TASKS OF
GENERAL TASKS OF
GENERAL TASKS OF
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49
THE AGENCY
THE AGENCY
THE AGENCY
THE AGENCY
G
Text Origin: Commission
Proposal
Article 1
Article 1
Article 1
Article 1
Article 1
Establishment of the Agency Establishment of the Agency Establishment of the Agency Establishment of the Agency
G
50
G
Text Origin: Commission
Proposal
Article 1(1)
1. This Regulation
1. This Regulation
1. This Regulation
1. This Regulation
establishes the European
establishes the European
establishes the European
establishes the European
Union Drugs Agency (‘the
Union Drugs Agency (‘the
Union Drugs Agency (‘the
Union Drugs Agency (‘the
G
51
Agency’).
Agency’).
Agency’).
Agency’).
G
Text Origin: Commission
Proposal
Article 1(2)
2. The Agency shall replace 2. The Agency shall replace 2. The Agency shall replace 2. The Agency shall replace
G
52
and succeed the European
and succeed the European
and succeed the European
and succeed the European
G
Monitoring Centre for Drugs Monitoring Centre for Drugs Monitoring Centre for Drugs Monitoring Centre for Drugs
and Drug Addiction
and Drug Addiction
and Drug Addiction
and Drug Addiction
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 6/95
established by Regulation
established by Regulation
established by Regulation
established by Regulation
(EC) No 1920/2006.
(EC) No 1920/2006.
(EC) No 1920/2006.
(EC) No 1920/2006.
Text Origin: Commission
Proposal
Article 2
Article 2
Article 2
Article 2
Article 2
Legal status and seat
Legal status and seat
Legal status and seat
Legal status and seat
G
53
G
Text Origin: Commission
Proposal
Article 2(1)
1. The Agency shall be a
1. The Agency shall be a
1. The Agency shall be a
1. The Agency shall be a
body of the Union with legal body of the Union with legal body of the Union with legal body of the Union with legal
personality.
personality.
personality.
personality.
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54
G
Text Origin: Commission
Proposal
Article 2(2)
2. In each of the Member
2. In each of the Member
2. In each of the Member
2. In each of the Member
States, the Agency shall
States, the Agency shall
States, the Agency shall
States, the Agency shall
enjoy the most extensive
enjoy the most extensive
enjoy the most extensive
enjoy the most extensive
legal capacity accorded to
legal capacity accorded to
legal capacity accorded to
legal capacity accorded to
legal persons under national
legal persons under national
legal persons under national
legal persons under national
law. It shall, in particular, be law. It shall, in particular, be law. It shall, in particular, be law. It shall, in particular, be
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55
G
able to acquire or dispose of
able to acquire or dispose of
able to acquire or dispose of
able to acquire or dispose of
movable and immovable
movable and immovable
movable and immovable
movable and immovable
property and be a party to
property and be a party to
property and be a party to
property and be a party to
legal proceedings.
legal proceedings.
legal proceedings.
legal proceedings.
Text Origin: Commission
Proposal
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Article 2(3)
3. The seat of the Agency
3. The seat of the Agency
3. The seat of the Agency
3. The seat of the Agency
shall be in Lisbon, Portugal.
shall be in Lisbon, Portugal.
shall be in Lisbon, Portugal.
shall be in Lisbon, Portugal.
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56
G
Text Origin: Commission
Proposal
Article 3
Article 3
Article 3
Article 3
Article 3
Definitions
Definitions
Definitions
Definitions
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57
G
Text Origin: Commission
Proposal
Article 3, first paragraph, introductory part
For the purpose of this
For the purpose of this
For the purpose of this
For the purpose of this
Regulation:
Regulation:
Regulation:
Regulation:
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58
G
Text Origin: Commission
Proposal
Article 3, first paragraph, point (1)
(1) ‘drugs’ means drugs as
(1) ‘drugs’ means drugs as
(1) ‘drugs
drug ’ means
(1) ‘
drugsdrug ’ means
defined in Article 1, point 1, defined in Article 1, point 1, drugs as defined in Article 1,
drugs as defined in Article 1,
of Council Framework
of Council Framework
point 1, of Council
point 1, of Council
Decision 2004/757/JHA1;
Decision 2004/757/JHA1;
Framework Decision
Framework Decision
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59
_________
_________
2004/757/JHA1;
any of the
2004/757/JHA1;any of the
G
1. Council Framework Decision
1. Council Framework Decision
following:
following:
2004/757/JHA of 25 October 2004
2004/757/JHA of 25 October 2004
_________
_________
laying down minimum provisions
laying down minimum provisions
1. Council Framework Decision
1.
Council Framework Decision
on the constituent elements of
on the constituent elements of
2004/757/JHA of 25 October 2004
2004/757/JHA of 25 October 2004
criminal acts and penalties in the
criminal acts and penalties in the
laying down minimum provisions
laying down minimum provisions
field of illicit drug trafficking (OJ
field of illicit drug trafficking (OJ
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 8/95
L 335 11.11.2004, p. 8).
L 335 11.11.2004, p. 8).
on the constituent elements of
on the constituent elements of
criminal acts and penalties in the
criminal acts and penalties in the
field of illicit drug trafficking (OJ
field of illicit drug trafficking (OJ L
L 335 11.11.2004, p. 8).
335 11.11.2004, p. 8).
Text Origin: Council
Mandate
Article 3, first paragraph, point (1a)
(1a) a substance covered
(1a) a substance covered by
by the 1961 United Nations the 1961 United Nations
Single Convention on
Single Convention on
Narcotic Drugs, as
Narcotic Drugs, as
amended by the 1972
amended by the 1972
Protocol, or by the 1971
Protocol, or by the 1971
G
59a
G
United Nations Convention United Nations Convention
on Psychotropic
on Psychotropic
Substances;
Substances;
Text Origin: Council
Mandate
Article 3, first paragraph, point (1b)
(1b) any of the substances
(1b) any of the substances
listed in the Annex of
listed in the Annex of
Council Framework
Council Framework
Decision 2004/757/JHA1;
Decision 2004/757/JHA1;
_________
_________
1.
Council Framework Decision
1.
Council Framework Decision
2004/757/JHA of 25 October
2004/757/JHA of 25 October 2004
G
59b
G
2004 laying down minimum
laying down minimum provisions
provisions on the constituent
on the constituent elements of
elements of criminal acts and
criminal acts and penalties in the
penalties in the field of illicit
field of illicit drug trafficking (OJ
drug trafficking (OJ L 335
L 335 11.11.2004, p. 8).
11.11.2004, p. 8).
Text Origin: Council
Mandate
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Article 3, first paragraph, point (2)
(2) ‘new psychoactive
(2) ‘new psychoactive
(2) ‘new psychoactive
(2) ‘new psychoactive
substances’ means
substances’ means
substances’ means
substances’ means
substances as defined in
substances as defined in
substances as defined in
substances as defined in
Article 1, point 4, of
Article 1, point 4, of
Article 1, point 4, of
Article 1, point 4, of
G
60
Framework Decision
Framework Decision
Framework Decision
Framework Decision
G
2004/757/JHA;
2004/757/JHA;
2004/757/JHA;
2004/757/JHA;
Text Origin: Commission
Proposal
Article 3, first paragraph, point (3)
(3) ‘poly-substance use’
(3) ‘poly-substance use’
(3) ‘poly-substance use’
(3) ‘poly-substance use’
means the concomitant use
means the
concomitant
means the concomitant use
means the
concomitant use
of one or more psychoactive
useconsumption of one or
of one or more psychoactive of one or more psychoactive
substance or type of
more psychoactive substance substance or type of
substance or type of
substance, whether licit or
or type of substance,
substance, whether licit or
substance, whether
licit or
illicit, when those substances whether
illicit or licit
, in
illicit, when those substances
illicit, when those substances
are taken together with
particular medicinal
are taken together
illicit or
are taken togetherillicit or
drugs;
products, alcohol or
licit (in particular
licit (in particular medicinal
G
61
tobacco, at the same time as medicinal products,
products, alcohol, tobacco),
G
the consumption of drugs,
alcohol, tobacco), when
when consumed at the same
or the sequential
consumed at the same time time or sequentially within
consumption of one or more or sequentially within a
a short period of time with
such substance or type of
short period of time with
drugs;
substance, within a short
drugs;
period of time, or illicit,
Text Origin: Council
Mandate
when those substances are
taken together with drugs;
Article 3, first paragraph, point (4)
(4) ‘drug precursors’ means (4) ‘drug precursors’ means (4) ‘drug precursors’ means (4) ‘drug precursors’ means
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62
substances that are
substances that are
substances that are
substances that are
G
controlled and monitored in
controlled and monitored in
controlled and monitored in
controlled and monitored in
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accordance with Regulation
accordance with Regulation
accordance with Regulation
accordance with Regulation
(EC) No 273/2004 of the
(EC) No 273/2004 of the
(EC) No 273/2004 of the
(EC) No 273/2004 of the
European Parliament and of
European Parliament and of
European Parliament and of
European Parliament and of
the Council1 and with
the Council1 and with
the Council1 and with
the Council1 and with
Council Regulation (EC) No Council Regulation (EC) No Council Regulation (EC) No Council Regulation (EC) No
111/20052;
111/20052;
111/20052;
111/20052;
_________
_________
_________
_________
1. Regulation (EC) No 273/2004 of
1. Regulation (EC) No 273/2004 of
1. Regulation (EC) No 273/2004 of
1. Regulation (EC) No 273/2004 of
the European Parliament and of the
the European Parliament and of the
the European Parliament and of the
the European Parliament and of the
Council of 11 February 2004 on
Council of 11 February 2004 on
Council of 11 February 2004 on
Council of 11 February 2004 on
drug precursors (OJ L 47,
drug precursors (OJ L 47,
drug precursors (OJ L 47,
drug precursors (OJ L 47,
18.2.2004, p. 1).
18.2.2004, p. 1).
18.2.2004, p. 1).
18.2.2004, p. 1).
2. Council Regulation (EC) No
2. Council Regulation (EC) No
2. Council Regulation (EC) No
2. Council Regulation (EC) No
111/2005 of 22 December 2004
111/2005 of 22 December 2004
111/2005 of 22 December 2004
111/2005 of 22 December 2004
laying down rules for the
laying down rules for the
laying down rules for the
laying down rules for the
monitoring of trade between the
monitoring of trade between the
monitoring of trade between the
monitoring of trade between the
Community and third countries in
Community and third countries in
Community and third countries in
Community and third countries in
drug precursors (OJ L 22,
drug precursors (OJ L 22,
drug precursors (OJ L 22,
drug precursors (OJ L 22,
26.1.2005, p. 1).
26.1.2005, p. 1).
26.1.2005, p. 1).
26.1.2005, p. 1).
Text Origin: Commission
Proposal
Article 3, first paragraph, point (5)
(5) ‘participating countries’
(5) ‘participating countries’
(5) ‘participating countries’
(5) ‘participating countries’
means the Member States
means the Member States
means the Member States
means the Member States
and third countries which
and third countries which
and third countries which
and third countries which
have concluded an
have concluded an
have concluded an
have concluded an
agreement with the Union in agreement with the Union in agreement with the Union in agreement with the Union in
G
63
G
accordance with Article 54;
accordance with Article 54;
accordance with Article 54
accordance with Article 54
of this Regulation;
of this Regulation;
Text Origin: Council
Mandate
Article 3, first paragraph, point (6)
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64
(6) ‘international
(6) ‘international
(6) ‘international
(6) ‘international
G
organisation’ means an
organisation’ means an
organisation’ means an
organisation’ means an
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 11/95
organisation and its
organisation and its
organisation and its
organisation and its
subordinate bodies governed subordinate bodies governed subordinate bodies governed subordinate bodies governed
by public international law,
by public international law,
by public international law,
by public international law,
or any other body which is
or any other body which is
or any other body which is
or any other body which is
set up by, or on the basis of,
set up by, or on the basis of,
set up by, or on the basis of,
set up by, or on the basis of,
an agreement between two
an agreement between two
an agreement between two
an agreement between two
or more countries;
or more countries;
or more countries;
or more countries;
Text Origin: Commission
Proposal
Article 3, first paragraph, point (7)
(7) ‘United Nations Drug
(7) ‘United Nations Drug
(7) ‘United Nations Drug
(7) ‘United Nations Drug
Conventions’ means the
Conventions’ means the
Conventions’ means the
Conventions’ means the
United Nations Single
United Nations Single
United Nations Single
United Nations Single
Convention on Narcotic
Convention on Narcotic
Convention on Narcotic
Convention on Narcotic
Drugs of 1961 as amended
Drugs of 1961 as amended
Drugs of 1961 as amended
Drugs of 1961 as amended
by the 1972 Protocol1, the
by the 1972 Protocol1, the
by the 1972 Protocol1, the
by the 1972 Protocol1, the
United Nations Convention
United Nations Convention
United Nations Convention
United Nations Convention
on Psychotropic Substances
on Psychotropic Substances
on Psychotropic Substances
on Psychotropic Substances
of 19712 and the United
of 19712 and the United
of 19712 and the United
of 19712 and the United
Nations Convention against
Nations Convention against
Nations Convention against
Nations Convention against
Illicit Traffic in Narcotic
Illicit Traffic in Narcotic
Illicit Traffic in Narcotic
Illicit Traffic in Narcotic
G
65
G
Drugs and Psychotropic
Drugs and Psychotropic
Drugs and Psychotropic
Drugs and Psychotropic
Substances of 19883;
Substances of 19883;
Substances of 19883;
Substances of 19883;
_________
_________
_________
_________
1. United Nations Treaty Series,
1. United Nations Treaty Series,
1. United Nations Treaty Series,
1. United Nations Treaty Series,
vol. 976, No. 14152.
vol. 976, No. 14152.
vol. 976, No. 14152.
vol. 976, No. 14152.
2. United Nations Treaty Series,
2. United Nations Treaty Series,
2. United Nations Treaty Series,
2. United Nations Treaty Series,
vol. 1019, No. 14956.
vol. 1019, No. 14956.
vol. 1019, No. 14956.
vol. 1019, No. 14956.
3. United Nations, Treaty Series,
3. United Nations, Treaty Series,
3. United Nations, Treaty Series,
3. United Nations, Treaty Series,
vol. 1582, No. 27627.
vol. 1582, No. 27627.
vol. 1582, No. 27627.
vol. 1582, No. 27627.
Text Origin: Commission
Proposal
Article 3, first paragraph, point (8)
G
66
G
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(8) ‘United Nations system’ (8) ‘United Nations system’ (8) ‘United Nations system’ (8) ‘United Nations system’
means the control
means the control
means the control
means the control
mechanism system
mechanism system
mechanism system
mechanism system
established by the United
established by the United
established by the United
established by the United
Nations Drug Conventions.
Nations Drug Conventions.
Nations Drug Conventions.
Nations Drug Conventions.
Text Origin: Commission
Proposal
Article 4
Article 4
Article 4
Article 4
Article 4
General task of the Agency
General task of the Agency
General task of the Agency
General task of the Agency
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67
G
Text Origin: Commission
Proposal
Article 4, first paragraph
The Agency shall provide
The Agency shall
provide
The Agency shall provide
The Agency shall
provide
the Union and its Member
the Union and its Member
the Union and its Member
the Union and its Member
States with factual,
States with factual,
States with factual,
States with factual,
objective, reliable and
objective, reliable and
objective, reliable and
objective, reliable and
comparable information,
comparable information,
comparable information,
comparable information,
early warning and risk
early warning and risk
early warning and risk
early warning and risk
assessment at Union level
assessment at Union level
assessment at Union level
assessment at Union level
concerning drugs, drug
concerning drugs, drug
concerning drugs, drug
concerning drugs, drug
addiction, drug markets and
addiction, drug markets and
addiction, drug markets
use,
addiction, drug markets and
Y
68
their consequences, and to
their consequences, and to
drug use disorders and
their consequences, and to
Y
recommend appropriate and
recommend appropriate and addictions, prevention,
recommend appropriate and
concrete, evidence-based
concrete, evidence-based
treatment, care, risk and
concrete, evidence-based
actions on how to address
actions on how to address
harm reduction,
actions on how to address
the related challenges in a
the related challenges in a
rehabilitation, social
the related challenges in a
timely manner.
timely manner.:
reintegration and recovery, timely manner.:
drug supply, including
illicit production and
Text Origin: EP Mandate
trafficking, and other
relevant drug related
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issues and their
consequences, and to
recommend appropriate and
concrete, evidence-based
actions on how to address
the related challenges in a
an
efficient and timely manner.
In carrying out its tasks,
the Agency shall take an
evidence-based, integrated,
balanced and
multidisciplinary approach
to the drugs phenomenon,
incorporating a human
rights, gender equality,
public health and health
equity perspective.
Article 4, first paragraph, point (a)
(a) provide the Union and
(a) provide the Union and
its Member States with
its Member States with
factual, objective, reliable
factual, objective, reliable
and comparable
and comparable
information, early warning
information, early warning
and risk assessment at
and risk assessment at
Union level concerning
Union level concerning
drugs, drug markets, drug
drugs, drug use, drug use
Y
68a
use, drug use disorders,
disorders and addictions,
Y
drug addictions, prevention,
prevention, treatment, care,
treatment, care, risk and
risk and harm reduction,
harm reduction,
rehabilitation, social
rehabilitation, social
reintegration, recovery,
reintegration, recovery,
drug markets and supply,
drug supply and other
including illicit production
relevant drug related issues
and trafficking, and other
and their consequences;
relevant drug related issues
and
and their consequences;
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and Text Origin: EP Mandate
Article 4, first paragraph, point (b)
(b) recommend appropriate
(b) recommend appropriate
and concrete evidence-
and concrete evidence-
based actions on how to
based actions on how to
address the challenges set
address the challenges set
Y
68b
Y
out in point (a) in an
out in point (a) in an
efficient and timely manner.
efficient and timely manner.
Text Origin: EP Mandate
Article 4, first paragraph a
In carrying out its tasks, the
In carrying out its tasks, the Parts in square brackets to be
Agency shall ensure full
Agency shall ensure full
confirmed.
compliance with
compliance with
Council's lawyer-linguists
fundamental rights and
fundamental rights and
suggest "perspectives"
data protection rules, act in
data protection rules, and
a transparent, objective,
take an evidence-based,
impartial and scientifically
integrated, balanced and
rigorous manner, and take
multidisciplinary approach
an evidence-based,
to the drugs phenomenon.
Y
68c
Y
integrated, balanced and
That approach shall
multidisciplinary approach
incorporate human rights,
to the drugs phenomenon.
gender [and gender
That approach shall
equality], age, public
incorporate human rights,
health, health equity and
gender, age, public health,
social perspectives [or:
health equity and social
aspects] .
perspectives.
Text Origin: EP Mandate
Article 5
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Article 5
Article 5
Article 5
Article 5
Specific tasks
Specific tasks
Specific tasks
Specific tasks
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G
Text Origin: Commission
Proposal
Article 5(1), introductory part
1. In order to implement the 1. In order to implement the 1. In order to implement the 1. In order to implement the
general task set out in
general task set out in
general task set out in
general task set out in
Article 4, the Agency shall
Article 4, the Agency shall
Article 4, the Agency shall
Article 4, the Agency shall
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70
perform the following tasks: perform the following tasks: perform the following tasks: perform the following tasks:
G
Text Origin: Commission
Proposal
Article 5(1), point (a), introductory part
(a) monitoring tasks that
(a) monitoring tasks that
(a) monitoring tasks that
(a) monitoring tasks that
shall include:
shall include:
shall include:
shall include:
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71
G
Text Origin: Commission
Proposal
Article 5(1), point (a)(1)
(1) the collection of
(1) the collection
and
(1) the collection
and
(1) the collection
and
information and data
analysis of information and
analysis of information and
analysis of information and
pursuant to Article 6(1);
data pursuant to Article 6(1); data pursuant to Article 6(1); data pursuant to Article 6(1);
G
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G
Text Origin: Council
Mandate
Article 5(1), point (a)(2)
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73
(2) the dissemination of
(2) the dissemination of
(2) the dissemination of
(2) the dissemination of
G
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information and data
information
, data and
information
, data and
information
, data and
pursuant to Article 6(5); and
results of analyses and data
results of analysis and data
results of analyses and data
pursuant to Article 6(5)
; and pursuant to Article 6(5); and pursuant to Article 6(5)
; and
Text Origin: EP Mandate
Article 5(1), point (a)(3)
(3) the monitoring of the
(3) the monitoring of the
(3) the monitoring of the
(3) the monitoring of the
drug phenomenon,
drug phenomenon,
drug phenomenon,
drug phenomenon,
encompassing the public
encompassing the public
encompassing the public
encompassing the
public
health, safety and security
health,
social and human
health
health, social, safety
healthhealth, human rights,
dimension, pursuant to
rights, safety and security
and security dimension,
social, safety and security
Y
74
Y
Article 7.
dimension, pursuant to
pursuant to Article 7.
dimension, pursuant to
Article 7.
Article 7.
Text Origin: Council
Mandate
Article 5(1), point (b), introductory part
(b) preparedness tasks that
(b) preparedness tasks that
(b) preparedness tasks that
(b) preparedness tasks that
shall include:
shall include:
shall include:
shall include:
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G
Text Origin: Commission
Proposal
Article 5(1), point (b)(1)
(1) the information
(1) the information
(1) the information
(1) the information
exchange on and early
exchange on and early
exchange on and early
exchange on and early
warning system for new
warning system for new
warning system for new
warning system for new
psychoactive substances,
psychoactive substances,
psychoactive substances,
psychoactive substances,
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G
including the preparation of
including the preparation of
including the preparation of
including the preparation of
an initial report and risk
an initial report and risk
an initial report and risk
an initial report and risk
assessment, pursuant to
assessment, pursuant to
assessment, pursuant to
assessment, pursuant to
Articles 8 to 11;
Articles 8 to 11;
Articles 8 to 11;
Articles 8 to 11;
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Text Origin: Commission
Proposal
Article 5(1), point (b)(2)
(2) threat assessment and
(2)
health and security
(2)
health and security
(2)
health and security
preparedness pursuant to
threat assessment and
threat assessment and
threat assessment and
Article 12;
preparedness pursuant to
preparedness pursuant to
preparedness pursuant to
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Article 12;
Article 12;
Article 12;
Text Origin: EP Mandate
Article 5(1), point (b)(3)
(3) the establishment and
(3) the establishment and
(3) the establishment and
(3) the establishment and
operation of a European
operation of a European
operation of a European drug operation of a European drug
drug alert system pursuant to drug alert system pursuant to alert system pursuant to
alert system pursuant to
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78
Article 13;
Article 13;
Article 13;
Article 13;
G
Text Origin: Commission
Proposal
Article 5(1), point (b)(4)
(4) monitoring the
(4) monitoring the
(4) monitoring the
(4) monitoring the
developments related to
developments related to
developments related to
developments related to
trafficking and diversion of
trafficking and diversion of
trafficking and diversion of
trafficking and diversion of
drug precursors and
drug precursors and
drug precursors and
drug precursors and
contributing to the
contributing to the
contributing to the
contributing to the
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79
implementation of drug
implementation of drug
implementation of drug
implementation of drug
G
precursors legislation
precursors legislation
precursors legislation
precursors legislation
pursuant to Article 14;
pursuant to Article 14;
pursuant to Article 14;
pursuant to Article 14;
Text Origin: Commission
Proposal
Article 5(1), point (b)(5)
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(5) the establishment and
(5) the establishment and
(5) the establishment and
(5) the establishment and
operation of a network of
operation of a network of
operation of a network of
operation of a network of
forensic and toxicological
forensic and toxicological
forensic and toxicological
forensic and toxicological
laboratories pursuant to
laboratories pursuant to
laboratories pursuant to
laboratories pursuant to
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G
Article 15;
Article 15;
Article 15;
Article 15;
Text Origin: Commission
Proposal
Article 5(1), point (c), introductory part
(c) competence
(c) competence
(c) competence
(c) competence
development tasks that shall
development tasks that shall
development tasks that shall
development tasks that shall
include:
include:
include:
include:
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G
Text Origin: Commission
Proposal
Article 5(1), point (c)(1)
(1) the development,
(1) the development
,
(1) the development,
(1) the development
,
expansion and promotion of
expansion and promotion of
expansion and promotion of
expansion and promotion of
Union-wide prevention
Union-wide prevention
Union-wide prevention
Union-wide prevention
programmes and campaigns
programmes and
programmes and
programmes and
pursuant to Article 16;
campaignsevidence-based
campaigns
evidence-based
campaignsevidence-based
interventions, best practices interventions, best
interventions, best practices
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82
G
and awareness raising
practices and awareness
and awareness raising
pursuant to Article 16;
raising activities pursuant to
activities pursuant to Article
Article 16;
16;
Text Origin: Council
Mandate
Article 5(1), point (c)(2)
83
(2) the accreditation and
(2) the accreditation and
(2) the accreditation and
To be addressed after
certification of national
certification of national
certification
assessment of
discussions on Article 17
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measures pursuant to Article measures pursuant to Article national measures pursuant
17;
17;
to Article 17;
Article 5(1), point (c)(3)
(3) support to Member
(3) support to Member
(3) support to Member
(3) support to Member
States pursuant to Article 18; States pursuant to Article 18; States pursuant to Article 18; States pursuant to Article 18;
G
84
G
Text Origin: Commission
Proposal
Article 5(1), point (c)(4)
(4) training pursuant to
(4) training pursuant to
(4) training pursuant to
(4) training pursuant to
Article 19;
Article 19;
Article 19;
Article 19;
G
85
G
Text Origin: Commission
Proposal
Article 5(1), point (c)(5)
(5) international cooperation (5) international cooperation (5) international cooperation (5) international cooperation
and technical assistance
and technical assistance
and technical assistance
and technical assistance
pursuant to Article 20;
pursuant to Article 20;
pursuant to Article 20;
pursuant to Article 20;
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G
Text Origin: Commission
Proposal
Article 5(1), point (c)(6)
(6) research and innovation
(6) research and innovation
(6) research and innovation
(6) research and innovation
activities pursuant to Article activities pursuant to Article activities pursuant to Article activities pursuant to Article
21.
21.
21.
21.
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87
G
Text Origin: Commission
Proposal
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Article 5(2)
2. The Agency shall
2. The Agency shall
2. The Agency shall
2. The Agency shall
establish and coordinate, in
establish and coordinate, in
establish and coordinate, in
establish and coordinate, in
consultation and in
consultation and in
consultation and in
consultation and in
cooperation with the
cooperation with the
cooperation with the
cooperation with the
competent authorities and
competent authorities and
competent authorities and
competent authorities and
organisations in the
organisations in the
organisations in the
organisations in the
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88
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participating countries, the
participating countries, the
participating countries, the
participating countries, the
network referred to in
network referred to in
network referred to in
network referred to in
Article 31.
Article 31.
Article 31.
Article 31.
Text Origin: Commission
Proposal
Article 5(3)
3. The Agency shall act in
3. The Agency shall act in
3. The Agency shall act in
Based on EP amendment in
an objective, impartial and
deleted
an objective, impartial and
ana transparent, objective,
Art. 4 / line 68
scientifically rigorous
scientifically rigorous
impartial and scientifically
manner when carrying out
manner when carrying out
rigorous manner when
and implementing the tasks
and implementing the tasks
carrying out and
Y
89
Y
referred to in paragraph 1.
referred to in paragraph 1.
implementing the tasks
referred to in paragraph 1.
Text Origin: Council
Mandate
Article 5(4)
4. The Agency shall
4. The Agency shall
support 4. The Agency shall
4. The Agency shall
support
improve coordination
and improve coordination
support and improve
and improve coordination
between national and Union
between national and Union
coordination between
between national and Union
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90
action in its areas of activity
action in its areas of activity
national and Union action in action in its areas of activity
G
and facilitate exchanges of
and facilitate exchanges of
its areas of activity and
and facilitate exchanges of
information between
information between
facilitate exchanges of
information between
decision-makers,
decision-makers,
information between
decision-makers,
researchers, specialists and
researchers, specialists and
decision-makers,
researchers, specialists and
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those involved in drug-
those involved in drug-
researchers, specialists and
those involved in drug-
related issues in
related issues in
those involved in drug-
related issues in
governmental and non-
governmental and non-
related issues in
governmental and non-
governmental organisations.
governmental organisations.
governmental and non-
governmental organisations.
governmental organisations.
Text Origin: EP Mandate
Article 5(4a)
4a. In cooperation with
[see how to address these
civil society organisations,
elements in line 94]
the Agency shall develop a
communication strategy in
90a
order to raise public
awareness and actively
disseminate information
about its work.
Article 5(5)
5. The Agency shall support 5. The Agency shall support 5. The Agency shall support 5. The Agency shall support Exact wording on "strategic
the Commission, Member
the Commission, Member
the Commission, Member
the Commission, Member
documents" to be checked
States and other relevant
States and other relevant
States and other relevant
States and other relevant
by lawyer-linguists
stakeholders, identified in
stakeholders, identified in
stakeholders, identified in
stakeholders, identified in
the applicable Union
the applicable Union
the applicable Union
the applicable Union
strategies on drugs, in the
strategies on drugs, in the
strategies on drugs
drugs
strategies on drugsdrugs
Y
91
implementation of those
implementation of those
related strategic
related strategic documents,
Y
strategies, as appropriate.
strategies, as appropriate.
documents, in the
in the implementation of
implementation of those
those
strategiesstrategic
strategies
strategic
documents, as appropriate.
documents, as appropriate.
Text Origin: Council
Mandate
Article 5(6)
Y
92
6. In carrying out and
6. In carrying out and
6. In carrying out and
6. In carrying out and
Reference to Reitox related Y
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implementing the tasks
implementing the tasks
implementing the tasks
implementing the tasks
to other provisions on Reitox
referred to in paragraph 1,
referred to in paragraph 1,
referred to in paragraph 1,
referred to in paragraph 1,
/ NFPs.
the Agency may organise
the Agency may organise
the Agency may organise
the Agency may organise
meetings of experts, set up
meetings of experts, set up
meetings of experts, set up
meetings of experts, set up
Holding meetings online to
ad hoc working groups and
ad hoc working groups and
ad hoc working groups and
ad hoc working groups and
be addressed in the recitals.
finance projects, as
finance projects, as
finance projects, as
finance projects, as
necessary.
necessary.
necessary
, keeping the
necessary
[, keeping the
Reitox network as referred Reitox network as referred
to in Article 31 informed in to in Article 31 informed in
a timely manner. When
a timely manner.
]
organising those meetings,
the possibility of online
Text Origin: Council
Mandate
meetings shall be
considered.
Article 5(7)
7. In carrying out and
7. In
carrying out and
7. In carrying out and
7. In
carrying out and
implementing the tasks
implementing the tasks
implementing the tasks
implementing the tasks
referred to in paragraph 1,
referred to in paragraph 1,
referred to in paragraph 1,
referred to in paragraph 1,
the Agency shall cooperate
the Agency shall cooperate
the Agency shall cooperate
the Agency shall cooperate
actively with other Union
actively with other Union
actively with other Union
actively with other Union
decentralised agencies and
decentralised agencies and
decentralised agencies and
decentralised agencies and
bodies, in particular Europol,
bodies, in particular
bodies
bodies, offices and
bodies, in particular
Eurojust, the European
Europol, Eurojust, the
agencies within their
Europol, Eurojust, the
Medicines Agency, the
European Medicines
mandates, in particular
European Medicines
European Centre for Disease
Agency, the European
Europol, Eurojust,
Agency, the European
Y
93
Prevention and Control, civil
Centre for Disease
European Union Agency
Centre for Disease
Y
society organisations and
Prevention and Control,
for Fundamental Rights,
Prevention and Control,
other relevant stakeholders,
civil society organisations
European Union Agency
civil society organisations
to attain maximum
and other relevant
for Law Enforcement
and otherorder to attain
efficiency in monitoring,
stakeholders, to attain
Training (CEPOL), the
maximum efficiency in
assessing and responding to
maximum efficiency in
European Medicines
monitoring, assessing and
the drugs phenomenon.
monitoring, assessing and
Agency, the European
responding to the drugs
responding to the drugs
Centre for Disease
phenomenon, the Agency
phenomenon.order to attain
Prevention and Control
, the
shall, in carrying out and
maximum efficiency in
European Foundation for
implementing its tasks,
monitoring, assessing and
the Improvement in Living cooperate actively with
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responding to the drugs
and Working Conditions
relevant stakeholders,
to
phenomenon, the Agency
(Eurofound), scientific
attain maximum efficiency in
shall, in carrying out and
community, civil society
monitoring, assessing and
implementing its tasks,
organisations and other
responding to the drugs
cooperate actively with all
relevant stakeholders, to
phenomenon.including:
of the following:
attain maximum efficiency
in monitoring, assessing and Text Origin: EP Mandate
responding to the drugs
phenomenon.
Article 5(7), point (a)
(a) other relevant Union
(a) other relevant Union
bodies, offices and agencies,
bodies, offices and agencies,
within the limits of their
within the limits of their
mandates, in particular
mandates, in particular
Europol, Eurojust, the
Europol, Eurojust, the
European Union Agency
European Union Agency
for Fundamental Rights,
for Fundamental Rights,
the European Union
the European Union
Agency for Law
Agency for Law
Enforcement Training
Enforcement Training
Y
93a
(CEPOL), the European
(CEPOL), the European
Y
Medicines Agency, the
Medicines Agency, the
European Centre for
European Centre for
Disease Prevention and
Disease Prevention and
Control and the European
Control and the European
Foundation for the
Foundation for the
Improvement in Living and
Improvement in Living and
Working Conditions
Working Conditions
(Eurofound);
(Eurofound);
Text Origin: EP Mandate
Article 5(7), point (b)
Y
93b
(b) other international
(b) other international
Y
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bodies, offices and agencies,
bodies, offices and agencies,
in particular the UN
in particular the UNODC,
Economic and Social
UN Economic and Social
Council and the UN
Council and the
Narcotics Board; and
International Narcotics
Control Board; and Text Origin: EP Mandate
Article 5(7), point (c)
(c) the scientific
(c) the scientific
Clarify "academia" in
community, academia, civil
community, civil society
recitals if needed. According
society organisations, in
organisations [, in
to Council's lawyer-linguists,
particular the Civil Society
particular the Civil Society
"scientific community" is
Forum on Drugs, and
Forum on Drugs, and
sufficient, as it is a broad
affected communities,
affected communities,
notion encompassing all
including people who use
including people who use
scientists, whether from the
Y
93c
drugs;
drugs];
private sector (industry) ,
Y
academia or the public
Text Origin: EP Mandate
sector.
Reference to CSFD and
affected communities is
linked to other provisions
relating to civil society
Article 5(8)
8. The Agency may engage
8. The Agency may engage
8. The Agency may engage
8. The Agency
mayshall
Reference to civil society is
in communication activities
in communication activities
in communication activities
engage in communication
linked to other provisions on
on its own initiative within
on its own initiative within
on its own initiative within
activities on its own
civil society
Y
94
its mandate. The allocation
its mandate. The allocation
its mandate. The allocation
initiative within its mandate.
Y
of resources to
of resources to
of resources to
The allocation of resources
communication activities
communication activities
communication activities
to communication activities
shall not be detrimental to
shall not be detrimental to
shall not be detrimental to
shall not be detrimental to
the effective exercise of the
the effective exercise of the
the effective exercise of the
the effective exercise of the
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tasks referred to in
tasks referred to in
tasks referred to in paragraph tasks referred to in paragraph
paragraph 1. Communication paragraph 1. Communication 1. Communication activities
1. Communication activities
activities shall be carried out activities shall be carried out shall be carried out in
shall be carried out in
in accordance with relevant
in accordance with relevant
accordance with relevant
accordance with relevant
communication and
communication and
communication and
communication
strategy and
dissemination plans adopted
dissemination plans adopted
dissemination plans adopted
dissemination plans adopted
by the Management Board.
by the Management Board.
by the Management Board.
by the Management Board.
Relevant stakeholders[,
including scientific
community and civil society
organisations], may be
involved in the development
of those documents. Text Origin: Commission
Proposal
CHAPTER II
CHAPTER II
CHAPTER II
CHAPTER II
CHAPTER II
MONITORING
MONITORING
MONITORING
MONITORING
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Text Origin: Commission
Proposal
Article 6
Article 6
Article 6
Article 6
Article 6
Collection and dissemination Collection and dissemination Collection and dissemination Collection and dissemination
of information and data
of information and data
of information and data
of information and data
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Text Origin: Commission
Proposal
Article 6(1), introductory part
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97
1. The Agency shall:
1. The Agency shall:
1. The Agency shall:
1. The Agency shall:
G
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Text Origin: Commission
Proposal
Article 6(1), point (a)
(a) collect all relevant
(a) collect
all relevant
(a) collect all relevant
(a) collect
all relevant
information and data,
information and data,
information and data,
information and data,
including information and
including information and
including information and
including information and
data communicated by the
data communicated by the
data communicated by the
data communicated by the
national focal points,
national focal points,
national focal points,
national focal points,
resulting from research,
resulting from research,
resulting from research,
resulting from research,
available from open sources, available from open sources, available from open sources, available from open sources,
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98
and data emanating from
and data emanating from
and data emanating from
and data emanating from
G
Union, non-governmental
Union, non-governmental
Union, non-governmental
Union, non-governmental
sources and competent
sources and competent
sources and competent
sources and competent
international organisations;
international organisations
international organisations
international organisations
and bodies;
and bodies;
and bodies;
Text Origin: Council
Mandate
Article 6(1), point (b)
(b) collect information and
(b) collect information and
(b) collect information and
(b) collect information and
data needed for the
data needed for the
data needed for the
data needed for the
monitoring of poly-
monitoring of poly-
monitoring of poly-
monitoring of poly-
substance use as referred to
substance use
and its
substance use
and its
substance use
and its
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in Article 7(1), point (c);
consequences as referred to
consequences as referred to
consequences as referred to
in Article 7(1), point
(c)(ac); in Article 7(1), point (c)
(ac); in Article 7(1), point
(c)(ac);
Text Origin: EP Mandate
Article 6(1), point (c)
(c) collect the available
(c) collect the available
(c) collect the available
(c) collect the available
Y
100
information and data from
information and data from
information and data from
information and data from
Y
the national focal points and
the national focal points and
the national focal points and
the national focal points
and
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 27/95
the Europol national units on the Europol national units on the Europol national units
, in the Europol national units,
new psychoactive substances new psychoactive substances
cooperation with Europol,
in cooperation with
and communicate that
and communicate that
on new psychoactive
Europol, on new
information to the national
information to the national
substances and communicate psychoactive substances and
focal points and the Europol
focal points and the Europol
that information to the
communicate that
national units as well as to
national units as well as to
national focal points and the
information to the national
the Commission without
the Commission without
Europol national units as
focal points and the Europol
undue delay;
undue delay;
well as to the Commission
national units as well as to
without undue delay;
the Commission without
undue delay;
Text Origin: Council
Mandate
Article 6(1), point (d)
(d) collect and analyse
(d) collect and analyse
(d) collect and analyse
(d) collect and analyse
information and data on drug information and data on drug information and data on drug information and data on drug
precursors, their diversion
precursors, their diversion
precursors, their diversion
precursors, their diversion
G
101
and trafficking;
and trafficking;
and trafficking;
and trafficking;
G
Text Origin: Commission
Proposal
Article 6(1), point (e)
(e) conduct and commission (e) conduct and commission (e) conduct and commission (e) conduct and commission
research and monitoring
research and monitoring
research and monitoring
research and monitoring
studies, surveys, feasibility
studies, surveys, feasibility
studies, surveys, feasibility
studies, surveys, feasibility
studies, and pilot projects
studies, and pilot projects
studies, and pilot projects
studies, and pilot projects
G
102
necessary to accomplish its
necessary to accomplish its
necessary to accomplish its
necessary to accomplish its
G
tasks;
tasks;
tasks;
tasks;
Text Origin: Commission
Proposal
Article 6(1), point (f)
Y
103
Y
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(f) ensure improved
(f) ensure improved
(f) ensure improved
(f) ensure improved
Reference to NFPs related
comparability, objectivity
comparability, objectivity
comparability, objectivity
comparability, objectivity
to other provisions on NFPs
and reliability of information and reliability of information and reliability of information and reliability of information
and data at Union level by
and data at Union level by
and data at Union level by
and data at Union level by
establishing indicators and
establishing indicators and
establishing
, in cooperation establishing
, [in cooperation
common standards of a non-
common standards of a non-
with the national focal
with the national focal
binding nature, compliance
binding nature, compliance
points, indicators and
points], indicators and
with which may be
with which may be
indicators and common
indicators and common
recommended by the
recommended by the
standards of a non-binding
standards of a non-binding
Agency, with a view to
Agency, with a view to
nature
common standards,
naturecommon standards,
ensuring greater uniformity
ensuring greater uniformity
compliance with which may
compliance with which may
of the measurement methods of the measurement methods be recommended by the
be recommended by the
used by the Member States
used by the Member States
Agency, with a view to
Agency, with a view to
and the Union; in particular,
and the Union; in particular,
ensuring greater uniformity
ensuring greater uniformity
the Agency shall develop
the Agency shall develop
of the measurement methods of the measurement methods
tools and instruments to help tools and instruments to help used by the Member States
used by the Member States
Member States to monitor
Member States to monitor
and the Union; in particular,
and the Union;
in particular,
and evaluate their national
and evaluate their national
the Agency shall develop
the Agency shall develop
policies and the Commission policies and the Commission tools and instruments to help
tools and instruments to help
to monitor and evaluate
to monitor and evaluate
Member States to monitor
Member States to monitor
Union policies.
Union policies.
and evaluate their national
and evaluate their national
policies and the Commission
policies and the Commission
to monitor and evaluate
to monitor and evaluate
Union policies.
Union policies.
Text Origin: Council
Mandate
Article 6(1), point (fa)
(g) cooperate closely with
(g) cooperate closely with
relevant Union bodies,
relevant Union bodies,
offices and agencies and
offices and agencies and
Y
103a
international organisations international organisations
Y
and bodies, in particular
and bodies, in particular
Europol, UNODC and
UNODC and INCB, in
INCB, in order to facilitate order to facilitate the
the notification and avoid
notification and avoid
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 29/95
unnecessary burden for
unnecessary burden for
Member States.
Member States.
Text Origin: Council
Mandate
Article 6(2)
2. The Agency shall collect
2. The Agency shall collect
2. The Agency shall collect
2. The Agency shall collect
Last part in square brackets
relevant national data
relevant national data
relevant national data
relevant national data
related to other provisions
through the national focal
through the national focal
through the national focal
through the national focal
on NFPs
points. It shall also cooperate points. It shall also cooperate points. It
The national
points.
ItThe national
closely with other national,
closely with other national,
reporting package shall
reporting package shall
also Informal COM suggestion:
European and international
European and international
also cooperate closely with
cooperate closely with
organisations and bodies that organisations and bodies that other
be previously
otherbe previously discussed 2. The Agency shall collect
already have information of
already have information of
discussed and agreed
and agreed with the
relevant national data
this kind.
this kind.
The Agency may
among the national,
national
, European and
through the national focal
use additional national
European and international
international organisations
points.
ItThe national
sources of information.
organisations and bodies that
and bodies that already have reporting package shall
also
already have
focal points.
focal points. The Agency
cooperate closely with
The Agency may have
may have recourse to
otherbe previously discussed
recourse to additional
additional sources of
and agreed with the
Y
104
national sources of
information
of this kindfor
national
, European and
Y
information of this
national data while keeping international organisations
kind
while keeping the
the national focal point
and bodies that already have
national focal point
informed [in a timely
focal points. The Agency
informed in a timely
manner].
may have recourse to
manner.
additional sources of
Text Origin: Council
information
of this kindfor
Mandate
national data while keeping
the national focal point
informed [in a timely
manner].
The data collected
and transmitted by the
national focal points in line
with applicable national
legislation shall not make it
possible to identify
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individuals or small groups
of individuals and shall be
in compliance with the
relevant Union and national
law.
***
The Presidency would
suggest to further examine
this suggestion in particular
as regards the burden on the
National Focal Points.
Article 6(3)
3. The Agency shall
3. The Agency shall
3. The Agency shall
3. The Agency shall
develop, within its mandate,
develop, within its mandate,
develop, within its mandate,
develop, within its mandate,
data collection methods and
data collection methods and
data collection methods and
data collection methods and
approaches, including
approaches, including
approaches, including
approaches, including
G
105
through projects with
through projects with
through projects with
through projects with
G
external partners.
external partners.
external partners.
external partners.
Text Origin: Commission
Proposal
Article 6(4), first subparagraph
4. The Agency may
4. The Agency
may shall
4. The Agency may
shall
4. The Agency
may shall
develop the necessary digital develop the necessary digital develop the necessary digital develop the necessary digital
solutions through which
solutions through which
solutions through which
solutions through which
information and data are
information and data are
information and data are
information and data are
G
106
managed and automatically
collected, validated,
collected, validated,
collected, validated,
G
exchanged.
analysed, reported, managed
analysed, reported,
analysed, reported, managed
and
automatically
managed and automatically
and
automatically
exchangedexchanged,
exchanged
exchanged,
exchangedexchanged,
including in an automated
including in an automated
including in an automated
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 31/95
manner.
manner.
manner.
Text Origin: EP Mandate
Article 6(4), second subparagraph, introductory part
If such digital solutions are
G
107
developed, they shall:
deleted
deleted
deleted
G
Article 6(4), second subparagraph, point (a)
(a) enable the automated
collection of data, including
deleted
deleted
deleted
open source information,
G
108
while keeping the possibility
G
of manual data provision
available;
Article 6(4), second subparagraph, point (b)
(b) apply artificial
intelligence for data
deleted
deleted
deleted
G
109
validation, analysis and
G
automated reporting;
Article 6(4), second subparagraph, point (c)
(c) allow for the
computerised handling and
deleted
deleted
deleted
G
110
exchange of information,
G
data and documents.
Article 6(5), introductory part
G
111
G
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5. The Agency shall
5. The Agency shall
5. The Agency shall
5. The Agency shall
disseminate information and disseminate information and disseminate information and disseminate information and
data by:
data by:
data by:
data by:
Text Origin: Commission
Proposal
Article 6(5), point (a)
(a) making the information
(a) making the information
(a) making the information
(a) making the information
it produces available to the
it produces available to the
it produces available to the
it produces available to the
Union, the Member States
Union, the Member States
Union, the Member States
Union, the Member States
and other interested parties,
and other interested parties,
and other interested parties,
and other interested parties,
including as regards new
including as regards new
including as regards new
including as regards new
G
112
G
developments and changing
developments and changing
developments and changing
developments and changing
trends;
trends;
trends;
trends;
Text Origin: Commission
Proposal
Article 6(5), point (b)
(b) ensuring wide
(b) ensuring wide
(b) ensuring wide
(b) ensuring wide
dissemination of its analysis, dissemination of its analysis, dissemination of its analysis, dissemination of its analysis,
conclusions and reports;
conclusions and reports
,
conclusions and reports
,
conclusions and reports
,
including to the scientific
including to the scientific
including to the scientific
community, civil society
community, civil society,
community, civil society
organisations and affected
affected communities,
organisations, affected
communities, including
including people who use
communities, including
people who use drugs, with
drugs, excluding sensitive
people who use drugs, with
G
113
G
the exception of classified
non-classified and
the exception of sensitive
and sensitive non-classified
classified data in
non-classified and classified
data;
accordance with Article 49 data in accordance with
of this Regulation;
Article 49 of this
Regulation;
Text Origin: Council
Mandate
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Article 6(5), point (c)
(c) ensuring wide
(c) ensuring wide
(c)
ensuring wide
dissemination of reliable
dissemination of reliable
deleted
dissemination of reliable
data, excluding sensitive
data, excluding sensitive
data, excluding sensitive
non-classified and classified
non-classified and classified
non-classified and classified
data, through publishing, on
data, through publishing, on
data, through publishing, on
the basis of data which it
the basis of data which it
the basis of data which it
Y
114
gathers, a regular report on
gathers, a regular report on
gathers, a regular report on
Y
the state of the drugs
the state of the drugs
the state of the drugs
phenomenon, including data phenomenon, including data
phenomenon
, including data
on emerging trends;
on emerging trends;
on and emerging trends;
Text Origin: Commission
Proposal
Article 6(5), point (d)
(d) setting up and making
(d) setting up and making
(d) setting up and making
(d) setting up and making
available open scientific
available open scientific
available open scientific
available open scientific
documentation resources and documentation resources and documentation resources and documentation resources
assisting in the promotion of assisting in the promotion of assisting in the promotion of
and assisting in the
Y
115
information activities;
information activities;
information activities;
;
promotion of information
Y
activities;; Text Origin: Council
Mandate
Article 6(5), point (e)
(e) providing information
(e) providing information
(e) providing information
(e) providing information
on quality standards,
on quality standards,
on quality standards,
on quality standards,
innovative best practices and innovative best practices
,
innovative
evidence-based
innovativeevidence-based
Y
116
implementable research
innovative and
best practices
, innovative
best practices
, innovative
Y
results in the Member States implementable research
approaches, and
approaches, and
and facilitating the exchange results in the Member States implementable research
implementable research
and implementation of such
and facilitating the exchange results in the Member States results in the Member States
standard and practices.
and implementation of such
and facilitating the exchange and facilitating the exchange
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 34/95
standard and practices.
and implementation of such
and implementation of such
standard
standards and
standardstandards and
practices.
practices.
Text Origin: Council
Mandate
Article 6(5), point (ea)
(5a) The Agency may also
Look into lines 116a, c and
disseminate information
117 further.
and data disaggregated by
Member State.
COM informal suggestion:
(5a) Where relevant, the
Agency may also
disseminate disaggregated
Y
116a
information and data, in
Y
particular disaggregated by
Member State, gender/sex,
age, disability and socio-
economic status, in
accordance with the
relevant Union law, in
particular on data
protection.
Article 6(5), point (eb)
(5b) When disseminating
(5b) When disseminating
COM informal suggestion:
information and data, the
information and data, the
Agency shall make a
Agency shall make a
(5c) When disseminating
reference to the sources
reference to the sources
information and data, the
Y
116b
Y
thereof.
thereof.
Agency shall make a
reference to the sources
Text Origin: Council
thereof.
Mandate
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Article 6(5a)
5a. Where relevant, the
(see line 116a)
Agency may disseminate
information and data
disaggregated by Member
State, gender, age, disability
and socio-economic status,
Y
116c
in accordance with the
Y
relevant national legal
framework and Union data
protection law. Article 6 - paragraph 5
- subparagraph 1 a
(new)
Article 6(6)
6. The Agency shall not
6. The Agency shall not
6. The Agency shall
ensure,
Informal COM suggestion:
collect any data making it
collectdisseminate or
where possible, that the
possible to identify
transmit any data making it
data collected is
(5b) The Agency shall not
individuals or small groups
possible to identify
disaggregated by sex and
collect
disseminate or
of individuals. It shall refrain individuals or small groups
that the collection and
transmit any data making it
from any transmission of
of individuals.
It shall
presentation of data
possible to identify
information relating to
refrain from any
considers the gender-
individuals or small groups
specific individuals.
transmission of information
sensitive aspects of drugs
of individuals. It shall refrain
Y
117
relating to specific
policy. It shall not collect
from any transmission of
Y
individuals.
any data making it possible
information relating to
to identify individuals or
specific individuals.
small groups of individuals.
It shall refrain from any
transmission of information
relating to specific
individuals.
Article 7
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Article 7
Article 7
Article 7
Article 7
Monitoring of the drug
Monitoring of the drug
Monitoring of the drug
Monitoring of the drug
phenomenon
phenomenon
and sharing of phenomenon
and sharing of phenomenon
and sharing of
G
118
G
best practices
best practices
best practices
Text Origin: EP Mandate
Article 7(1), introductory part
1. The Agency shall
1. The Agency shall
1. The Agency shall
1. The Agency shall
monitor:
monitor:
monitor:
monitor:
G
119
G
Text Origin: Commission
Proposal
Article 7(1), point (a)
(a) the drugs phenomenon
(a) the drugs phenomenon
(a) the drugs phenomenon
(a) the drugs phenomenon
Explain in recitals: public
in the Union holistically,
in the Union holistically,
in the Union holistically,
in the Union holistically,
health vs health; that social
through epidemiological and through epidemiological and through epidemiological and through epidemiological and aspects cover social
other indicators, covering
other indicators, covering
other indicators, covering
other indicators, covering
reintegration.
the health, safety and
the
public health,
social and the health,
social, safety and the health,
human rights,
security aspects, including
human rights, social
security aspects, including
social, safety and security
Exact wording on "strategic
the implementation of the
reintegration, safety and
the implementation of the
aspects
[thereof], including
documents" (similarly as in
Y
120
Y
applicable Union strategies
security aspects
thereof,
applicable Union strategies
the implementation of the
line 91) + the need for
on drugs;
including the
on drugs
drug-related
applicable Union
strategies
"thereof"
implementation of the
strategic documents;
on drugsdrug-related
to be checked by lawyer-
applicable Union strategies
strategic documents;
linguists.
on drugs;
Text Origin: Council
Mandate
Article 7(1), point (aa)
Y
120a
(aa) evidence-based best
(aa) evidence-based best
Y
practices and innovative
practices and innovative
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approaches, regarding
approaches, regarding
health, social, safety or
health, human rights,
security responses;
social, safety or security
responses; Text Origin: Council
Mandate
Article 7(1), point (aa)
(aa) evidence-based best
Covered in line 120a
practices and innovative
above.
approaches to respond to
the public health, social and
To have a discussion
Y
120b
human rights, safety and
separately on "participating
Y
security aspects of the drugs
countries".
phenomenon in the
participating countries;
Article 7(1), point (ab)
(ab) emerging trends in the
Covered in line 120d
Union and internationally
with respect to drug use,
To have a discussion
drug use disorders, drug
separately on "participating
Y
120c
addictions and related
countries".
Y
health risks and harm in so
far as they impact the
participating countries;
Article 7(1), point (ab)
(ab) drug use, drug use
(ab) drug use, drug use
EP to check "risky
Y
120d
disorders, drug addictions
disorders, drug addictions
behaviours"
Y
and related health risks
and related health risks and
and harms and risky
harms [and risky
Council to see if alternative
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behaviours as well as
behaviours] as well as
wording more appropriate
emerging trends in these
emerging trends in these
fields;
fields;
COM informal suggestion:
Text Origin: Council
(ab) drug use, drug use
Mandate
disorders, drug addictions
and related health risks and
drug-related harms and
risky behaviours
, as well as
risk behaviours associated
with drug use as well as
emerging trends in these
fields;
Article 7(1), point (ac)
(ac) poly-substance use
(ac) poly-substance use and
and its consequences, in
its consequences, in
particular the increased
particular the increased
risks of health and social
risks of health and social
problems, the social
problems, the social
determinants of drug use,
determinants of drug use,
Y
120e
drug use disorders and
drug use disorders and
Y
addictions, as well as the
addictions, as well as the
implications for policies
implications for policies and
and responses;
responses;
Text Origin: Council
Mandate
Article 7(1), point (ac)
(ac) poly-substance use and
Covered in line 120e
its consequences, in
Y
120f
particular the increased
Y
risks of health and social
problems, the social
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determinants of drug use,
drug use disorders and drug
addictions, and the
implications for policies and
responses;
Article 7(1), point (ad)
(ad) drug and poly-
(ad) drug and poly-
substance use and their
substance use and its
consequences from a
consequences from a
gender perspective, in
gender perspective, in
Y
120g
particular their impact on
particular their impact on
Y
gender-based violence;
gender-based violence;
Text Origin: Council
Mandate
Article 7(1), point (ad)
(ad) drug and poly-
Covered in line 120g; "age"
substance use and its
covered elsewhere (e.g. Art.
consequences from an age
4)
Y
120h
and gender perspective, in
Y
particular its impact on
gender-based violence;
Article 7(1), point (b)
(b) emerging trends in the
(b) emerging trends in the
(b) emerging trends in the
This provision to be further
drugs phenomenon in the
drugs phenomenon in the
drugs phenomenon in the
discussed.
Union and internationally as Union and internationally as Union and internationally as
121
far as these impact on the
far as these impact on the
far as these impact on the
Union; this shall include the
Union; this shall include the
Union; this shall include the
monitoring of the use of new monitoring of the use of new monitoring of the use of new
technologies for drug
technologies for drug
technologies for drug
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services or drug trafficking,
services or drug trafficking,
services or drug trafficking,
and links to other crime
and links to other crime
and links to other crime
areas, as relevant;
areas, as relevant;
areas, as relevant
drug
supply, including illicit
production and trafficking
and other related crimes as
well as the use of new
technologies, in
cooperation with Europol
within their respective
mandates;
Article 7(1), point (c)
(c) poly-substance use and
its consequences, in
deleted
deleted
deleted
particular the implications
for policies and responses
arising from the interaction
between the use of drugs
with one or more
psychoactive substance or
type of substance, whether
licit or illicit; including the
increased risks of health and
G
122
social problems, which may
G
occur when drugs and other
psychoactive substances are
consumed at the same time
or sequentially within a short
period of time or when
different substances are
produced or sold together;
the need to consider the
common causes of drug use
and addictions; and the
implications for monitoring
and exchange of best
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practices, which arise when
policies and responses target
multiple substances
holistically;
Article 7(1), point (d)
(d) drug-related problems
and the solutions applied, in
deleted
deleted
deleted
particular the
G
123
implementation of
G
innovative best practices and
research results;
Article 7(1), point (e)
(e) in cooperation with
(e) in cooperation with
(e) in cooperation with
(e) in cooperation with
Europol and with the support Europol and with the support Europol and with the support Europol and with the support
of the national focal points
of the national focal points
of the national focal points
of the national focal points
and the Europol national
and the Europol national
and the Europol national
and the Europol national
units, all new psychoactive
units, all new psychoactive
units, all new psychoactive
units, all new psychoactive
G
124
G
substances that have been
substances that have been
substances that have been
substances that have been
reported by Member States;
reported by Member States;
reported by Member States;
reported by Member States;
Text Origin: Commission
Proposal
Article 7(1), point (f)
(f) drug precursors and their (f) drug precursors and their (f) drug precursors and their (f) drug precursors and their
[Last line discussed on
trafficking and diversion;
trafficking and diversion;
trafficking and diversion;
trafficking and diversion;
26/1]
G
125
G
Text Origin: Commission
Proposal
Article 7(1), point (g)
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(g) Union and national
(g) Union and national
(g)
the implementation of
(g)
the implementation of
drugs policies, including in
drugs policies, including in
the Union and national
the Union and national drugs
view of supporting their
view of supporting their
drugs policies, including in
policies, including in view of
development and
development and
view of supporting their
supporting their
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126
independent evaluation;
independent evaluation;
development and
development and
G
independent evaluation;
.
independent evaluation
;.
Text Origin: Council
Mandate
Article 7(1), point (h)
(h) Technology-enabled
[linked to line 121]
drug markets, in cooperation
deleted
deleted
deleted
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127
with Europol within their
G
respective mandates.
Article 7(2)
2. Based on its monitoring
2. Based on its monitoring
2. Based on its monitoring
2. Based on its monitoring
activities, the Agency shall
activities, the Agency shall
activities, the Agency shall
activities, the Agency shall
identify innovative best
identify innovative best
identify innovative
and
identify
innovative best
practices and develop them
practices and develop
them
support evidence-based
practices and develop them
further. The Agency shall
further. The Agency shall
best practices and develop
further. The Agency shall
provide and share
provide and share
them further. The Agency
provide and share
information on innovative
information on
shall provide
innovative
information on innovative
best practices in the Member
innovativeand identify
approaches, and share
best practices inand support
Y
128
States and facilitate the
innovative and evidence-
information on innovative
[and, where appropriate, co-
Y
exchange of such practices
based best practices
, share
best practices in
them with
develop] evidence-based
among the Member States.
them with in the Member
the Member States and
best practices and
States and facilitate the
facilitate the exchange of
innovative approaches, and
exchange of such practices
such practices
thereof among
share them with the
among
the Member
the Member States
them.
Member States and facilitate
Statesthem.
the exchange
of such
practicesthereof among
the
Member Statesthem.
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Text Origin: Council
Mandate
Article 7(2a)
2a. The Agency shall, in
2a. The Agency shall
NB: This provision does
cooperation with the
develop tools and
not prejudge the provisions
national focal points,
instruments to help Member on certification / assessment.
develop tools and
States to monitor and
instruments to help
evaluate their national
Member States to monitor
policies, in cooperation with
Y
128a
and evaluate their national the national focal points,
Y
policies and the
and the Commission to
Commission to monitor
monitor and evaluate Union
and evaluate Union
policies.
policies.
Text Origin: Council
Mandate
Article 7(3)
3. The Agency shall
3. The Agency shall
3. The Agency shall
3. The Agency shall
Elements from EP
undertake regular foresight
undertake regular foresight
undertake regular foresight
undertake regular foresight
amendment covered in lines
exercises, taking into
exercises, taking into
exercises, taking into
exercises, taking into
113 and 128
account the information
account the information
account the information
account the information
available. It shall develop,
available. Itprovide data,
available. It shall develop,
available. It shall develop,
on that basis, relevant
analysis and best practices
on that basis, relevant
on that basis, relevant
predictions for the
to, and share the latest
predictions
scenarios for the
predictionsscenarios for the
development of future drugs
evidence-based policy
development of future drugs development of future drugs
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129
policy.
recommendations with, the
policy.
policy.
G
Commission and the
Member States, provided
Text Origin: Council
Mandate
that such data, analysis,
best practices and policy
recommendations concern
Union and national policies
which address the
phenomenon of drug
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addictions. The Agency shall develop, on that basis,
relevant
predictionsscenarios for the
development of future drugs
policy.
The Agency shall
undertake regular foresight
exercises, taking into
account the information
available.
CHAPTER III
CHAPTER III
CHAPTER III
CHAPTER III
CHAPTER III
PREPAREDNESS
PREPAREDNESS
PREPAREDNESS
PREPAREDNESS
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130
G
Text Origin: Commission
Proposal
Article 8
Article 8
Article 8
Article 8
Article 8
Information exchange on,
Information exchange on,
Information exchange on,
Information exchange on,
and early warning system
and early warning system
and early warning system
and early warning system
for, new psychoactive
for, new psychoactive
for, new psychoactive
for, new psychoactive
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131
G
substances
substances
substances
substances
Text Origin: Commission
Proposal
Article 8(1), first subparagraph
1. Each Member State shall
1. Each Member State shall
1. Each Member State shall
1. Each Member State shall
ensure that its national focal
ensure that its national focal
ensure that its national focal
ensure that its national focal
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132
point and its Europol
point and its Europol
point and its Europol
point and its Europol
G
national unit provide the
national unit provide the
national unit provide the
national unit provide the
Agency and Europol, taking
Agency and Europol, taking
Agency and Europol, taking
Agency and Europol, taking
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into account their respective
into account their respective
into account their respective
into account their respective
mandates, with the available mandates, with the available mandates, with the available mandates, with the available
information on new
information on new
information on new
information on new
psychoactive substances in a psychoactive substances in a psychoactive substances in a psychoactive substances in a
timely manner and without
timely manner and without
timely manner and without
timely manner and without
undue delay.
undue delay.
undue delay.
undue delay.
Text Origin: Commission
Proposal
Article 8(1), second subparagraph
The information shall be
The information shall be
The information shall be
The information shall be
related to the detection and
related to the detection and
related to the detection and
related to the detection and
identification, use and
identification, use and
identification, use and
identification, use and
patterns of use, manufacture, patterns of use, manufacture, patterns of use, manufacture, patterns of use, manufacture,
extraction, distribution and
extraction, distribution and
extraction, distribution and
extraction, distribution and
distribution methods,
distribution methods,
distribution methods,
distribution methods,
trafficking, and commercial, trafficking, and commercial, trafficking, and commercial, trafficking, and commercial,
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133
G
medical and scientific use of, medical and scientific use of, medical and scientific use of, medical and scientific use of,
and potential and identified
and potential and identified
and potential and identified
and potential and identified
risks posed by, those
risks posed by, those
risks posed by, those
risks posed by, those
substances.
substances.
substances.
substances.
Text Origin: Commission
Proposal
Article 8(2), first subparagraph
2. The Agency, in
2. The Agency, in
2. The Agency, in
2. The Agency, in
cooperation with Europol,
cooperation with Europol,
cooperation with Europol,
cooperation with Europol,
shall collect, collate, analyse shall collect, collate, analyse shall collect, collate, analyse shall collect, collate, analyse
and assess information on
and assess information on
and assess information on
and assess information on
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134
new psychoactive
new psychoactive
new psychoactive
new psychoactive
G
substances. It shall
substances. It shall
substances. It shall
substances. It shall
communicate this
communicate this
communicate this
communicate this
information in a timely
information in a timely
information in a timely
information in a timely
manner to the national focal
manner to the national focal
manner to the national focal
manner to the national focal
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points, the Europol national
points, the Europol national
points, the Europol national
points, the Europol national
units, and the Commission
units, and the Commission
units, and the Commission
units, and the Commission
with a view to providing
with a view to providing
with a view to providing
with a view to providing
them with any information
them with any information
them with any information
them with any information
required for the purposes of
required for the purposes of
required for the purposes of
required for the purposes of
early warning.
early warning.
early warning.
early warning.
Text Origin: Commission
Proposal
Article 8(2), second subparagraph
The Agency shall draw up
The Agency shall draw up
The Agency shall draw up
The Agency shall draw up
the initial report or the
the initial report or the
the initial report or the
the initial report or the
combined initial report
combined initial report
combined initial report
combined initial report
pursuant to Article 9 based
pursuant to Article 9 based
pursuant to Article 9 based
pursuant to Article 9 based
on the information collected
on the information collected
on the information collected
on the information collected
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135
G
pursuant to the first
pursuant to the first
pursuant to the first
pursuant to the first
subparagraph.
subparagraph.
subparagraph.
subparagraph.
Text Origin: Commission
Proposal
Article 9
Article 9
Article 9
Article 9
Article 9
Initial report
Initial report
Initial report
Initial report
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136
G
Text Origin: Commission
Proposal
Article 9(1), first subparagraph
1. Where the Agency, the
1. Where the Agency, the
1. Where the Agency, the
1. Where the Agency, the
Commission or the majority
Commission or the majority
Commission or the majority
Commission or the majority
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137
of Member States considers
of Member States considers
of Member States considers
of Member States considers
G
that information shared on a
that information shared on a
that information shared on a
that information shared on a
new psychoactive substance
new psychoactive substance
new psychoactive substance
new psychoactive substance
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collected in one or more
collected in one or more
collected in one or more
collected in one or more
Member States gives rise to
Member States gives rise to
Member States gives rise to
Member States gives rise to
concerns that the new
concerns that the new
concerns that the new
concerns that the new
psychoactive substance may
psychoactive substance may
psychoactive substance may
psychoactive substance may
pose health or social risks at
pose health or social risks at
pose health or social risks at
pose health or social risks at
Union level, the Agency
Union level, the Agency
Union level, the Agency
Union level, the Agency
shall draw up an initial
shall draw up an initial
shall draw up an initial
shall draw up an initial
report on the new
report on the new
report on the new
report on the new
psychoactive substance.
psychoactive substance.
psychoactive substance.
psychoactive substance.
Text Origin: Commission
Proposal
Article 9(1), second subparagraph
For the purpose of the first
For the purpose of the first
For the purpose of the first
For the purpose of the first
subparagraph, Member
subparagraph, Member
subparagraph, Member
subparagraph, Member
States shall inform the
States shall inform the
States shall inform the
States shall inform the
Commission and other
Commission and other
Commission and other
Commission and other
Member States of their wish
Member States of their wish
Member States of their wish
Member States of their wish
that an initial report be
that an initial report be
that an initial report be
that an initial report be
drawn up. Where the
drawn up. Where the
drawn up. Where the
drawn up. Where the
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138
majority of Member States is majority of Member States is majority of Member States is majority of Member States is
G
reached, the Commission
reached, the Commission
reached, the Commission
reached, the Commission
shall instruct the Agency
shall instruct the Agency
shall instruct the Agency
shall instruct the Agency
accordingly and shall inform accordingly and shall inform accordingly and shall inform accordingly and shall inform
the Member States thereof.
the Member States thereof.
the Member States thereof.
the Member States thereof.
Text Origin: Commission
Proposal
Article 9(2), introductory part
2. The initial report shall
2. The initial report shall
2. The initial report shall
2. The initial report shall
contain:
contain:
contain:
contain:
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139
G
Text Origin: Commission
Proposal
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Article 9(2), point (a)
(a) a preliminary indication
(a) a preliminary indication
(a) a preliminary indication
(a) a preliminary indication
of the nature, number and
of the nature, number and
of the nature, number and
of the nature, number and
scale of incidents showing
scale of incidents showing
scale of incidents showing
scale of incidents showing
health and social problems
health and social problems
health and social problems
health and social problems
in which the new
in which the new
in which the new
in which the new
psychoactive substance may
psychoactive substance may
psychoactive substance may
psychoactive substance may
G
140
G
potentially be involved, and
potentially be involved, and
potentially be involved, and
potentially be involved, and
the patterns of use of the
the patterns of use of the
the patterns of use of the
the patterns of use of the
new psychoactive substance; new psychoactive substance; new psychoactive substance; new psychoactive substance;
Text Origin: Commission
Proposal
Article 9(2), point (b)
(b) a preliminary indication
(b) a preliminary indication
(b) a preliminary indication
(b) a preliminary indication
of the chemical and physical of the chemical and physical of the chemical and physical of the chemical and physical
description of the new
description of the new
description of the new
description of the new
psychoactive substance and
psychoactive substance and
psychoactive substance and
psychoactive substance and
the methods and precursors
the methods and precursors
the methods and precursors
the methods and precursors
G
141
G
used for its manufacture or
used for its manufacture or
used for its manufacture or
used for its manufacture or
extraction;
extraction;
extraction;
extraction;
Text Origin: Commission
Proposal
Article 9(2), point (c)
(c) a preliminary indication
(c) a preliminary indication
(c) a preliminary indication
(c) a preliminary indication
of the pharmacological and
of the pharmacological and
of the pharmacological and
of the pharmacological and
toxicological description of
toxicological description of
toxicological description of
toxicological description of
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142
the new psychoactive
the new psychoactive
the new psychoactive
the new psychoactive
G
substance;
substance;
substance;
substance;
Text Origin: Commission
Proposal
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Article 9(2), point (d)
(d) a preliminary indication
(d) a preliminary indication
(d) a preliminary indication
(d) a preliminary indication
of the involvement of
of the involvement of
of the involvement of
of the involvement of
criminal groups in the
criminal groups in the
criminal groups in the
criminal groups in the
manufacture or distribution
manufacture or distribution
manufacture or distribution
manufacture or distribution
G
143
of the new psychoactive
of the new psychoactive
of the new psychoactive
of the new psychoactive
G
substance;
substance;
substance;
substance;
Text Origin: Commission
Proposal
Article 9(2), point (e)
(e) information on the
(e) information on the
(e) information on the
(e) information on the
human and veterinary
human and veterinary
human and veterinary
human and veterinary
medical use of the new
medical use of the new
medical use of the new
medical use of the new
psychoactive substance,
psychoactive substance,
psychoactive substance,
psychoactive substance,
including as an active
including as an active
including as an active
including as an active
substance in a medicinal
substance in a medicinal
substance in a medicinal
substance in a medicinal
G
144
G
product for human use or in
product for human use or in
product for human use or in
product for human use or in
a veterinary medicinal
a veterinary medicinal
a veterinary medicinal
a veterinary medicinal
product;
product;
product;
product;
Text Origin: Commission
Proposal
Article 9(2), point (f)
(f) information on the
(f) information on the
(f) information on the
(f) information on the
commercial and industrial
commercial and industrial
commercial and industrial
commercial and industrial
use of the new psychoactive
use of the new psychoactive
use of the new psychoactive
use of the new psychoactive
G
145
substance, the extent of such substance, the extent of such substance, the extent of such substance, the extent of such
G
use, as well as its use for
use, as well as its use for
use, as well as its use for
use, as well as its use for
scientific research and
scientific research and
scientific research and
scientific research and
development purposes;
development purposes;
development purposes;
development purposes;
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Text Origin: Commission
Proposal
Article 9(2), point (fa)
(fa) information on the
Covered in line 140.
health-related risks
G
145a
associated with new
G
psychoactive substances;
Article 9(2), point (g)
(g) information on whether
(g) information on whether
(g) information on whether
(g) information on whether
the new psychoactive
the new psychoactive
the new psychoactive
the new psychoactive
substance is subject to any
substance is subject to any
substance is subject to any
substance is subject to any
restrictive measures in the
restrictive measures in the
restrictive measures in the
restrictive measures in the
G
146
G
Member States;
Member States;
Member States;
Member States;
Text Origin: Commission
Proposal
Article 9(2), point (h)
(h) information on whether
(h) information on whether
(h) information on whether
(h) information on whether
the new psychoactive
the new psychoactive
the new psychoactive
the new psychoactive
substance is currently or has
substance is currently or has
substance is currently or has
substance is currently or has
been under assessment
been under assessment
been under assessment
been under assessment
G
147
within the United Nations
within the United Nations
within the United Nations
within the United Nations
G
system;
system;
system;
system;
Text Origin: Commission
Proposal
Article 9(2), point (i)
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148
(i) other relevant
(i) other relevant
(i) other relevant
(i) other relevant
G
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information, where
information, where
information, where
information, where
available.
available.
available.
available.
Text Origin: Commission
Proposal
Article 9(3)
3. For the purpose of the
3. For the purpose of the
3. For the purpose of the
3. For the purpose of the
initial report, the Agency
initial report, the Agency
initial report, the Agency
initial report, the Agency
shall use information, which shall use information, which shall use information, which shall use information, which
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149
is at its disposal.
is at its disposal
, including
is at its disposal.
is at its disposal.
G
information obtained
pursuant to Article 8.
Text Origin: Commission
Proposal
Article 9(4)
4. Where the Agency
4. Where the Agency
4. Where the Agency
4. Where the Agency
Cooperation with
considers it necessary, it
considers it necessary, it
considers it necessary, it
considers it necessary, it
stakeholders covered in line
shall request the national
shall request the national
shall request the national
shall request the national
93c; with civil society in
focal points to provide
focal points
and the relevant focal points to provide
focal points to provide
Art. 55.
additional information on the
stakeholders, including the
additional information on the additional information on the
new psychoactive substance.
scientific community,
new psychoactive substance. new psychoactive substance.
The national focal points
healthcare professionals,
The national focal points
The national focal points
shall provide that
civil society organisations
shall provide that
shall provide that
information within two
and affected communities,
information within two
information within two
Y
150
weeks of receipt of the
to provide additional
weeks of receipt of the
weeks of receipt of the
Y
request.
information on the new
request.
request.
psychoactive substance. The
national focal points
and the
Text Origin: Commission
Proposal
relevant stakeholders, as
applicable, shall provide that
information within two
weeks of receipt of the
request.
Article 9(5), first subparagraph, introductory part
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5. The Agency shall,
5. The Agency shall,
5. The Agency shall,
5. The Agency shall,
without undue delay after
without undue delay after
without undue delay after
without undue delay after
the start of drawing up of the the start of drawing up of the the start of drawing up of the the start of drawing up of the
initial report pursuant to the
initial report pursuant to the
initial report pursuant to the
initial report pursuant to the
first paragraph, request the
first paragraph, request the
first paragraph, request the
first paragraph, request the
European Medicines Agency European Medicines Agency European Medicines Agency European Medicines Agency
to provide information on
to provide information on
to provide information on
to provide information on
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151
G
whether, at Union or
whether, at Union or
whether, at Union or
whether, at Union or
national level, the new
national level, the new
national level, the new
national level, the new
psychoactive substance is an psychoactive substance is an psychoactive substance is an psychoactive substance is an
active substance in:
active substance in:
active substance in:
active substance in:
Text Origin: Commission
Proposal
Article 9(5), first subparagraph, point (a)
(a) a medicinal product for
(a) a medicinal product for
(a) a medicinal product for
(a) a medicinal product for
human use or in a veterinary human use or in a veterinary human use or in a veterinary human use or in a veterinary
medicinal product that has
medicinal product that has
medicinal product that has
medicinal product that has
obtained a marketing
obtained a marketing
obtained a marketing
obtained a marketing
authorisation in accordance
authorisation in accordance
authorisation in accordance
authorisation in accordance
with Directive 2001/83/EC
with Directive 2001/83/EC
with Directive 2001/83/EC
with Directive 2001/83/EC
of the European Parliament
of the European Parliament
of the European Parliament
of the European Parliament
and of the Council1,
and of the Council1,
and of the Council1,
and of the Council1,
Directive 2001/82/EC of the Directive 2001/82/EC of the Directive 2001/82/EC of the Directive 2001/82/EC of the
European Parliament and of
European Parliament and of
European Parliament and of
European Parliament and of
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152
G
the Council2 or Regulation
the Council2 or Regulation
the Council2 or Regulation
the Council2 or Regulation
(EC) No 726/2004 of the
(EC) No 726/2004 of the
(EC) No 726/2004 of the
(EC) No 726/2004 of the
European Parliament and of
European Parliament and of
European Parliament and of
European Parliament and of
the Council3;
the Council3;
the Council3;
the Council3;
_________
_________
_________
_________
1. Directive 2001/83/EC of the
1. Directive 2001/83/EC of the
1. Directive 2001/83/EC of the
1. Directive 2001/83/EC of the
European Parliament and of the
European Parliament and of the
European Parliament and of the
European Parliament and of the
Council of 6 November 2001 on
Council of 6 November 2001 on
Council of 6 November 2001 on
Council of 6 November 2001 on
the Community code relating to
the Community code relating to
the Community code relating to
the Community code relating to
medicinal products for human use
medicinal products for human use
medicinal products for human use
medicinal products for human use
(OJ L 311, 28.11.2001, p. 67).
(OJ L 311, 28.11.2001, p. 67).
(OJ L 311, 28.11.2001, p. 67).
(OJ L 311, 28.11.2001, p. 67).
2. Directive 2001/82/EC of the
2. Directive 2001/82/EC of the
2. Directive 2001/82/EC of the
2. Directive 2001/82/EC of the
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European Parliament and of the
European Parliament and of the
European Parliament and of the
European Parliament and of the
Council of 6 November 2001 on
Council of 6 November 2001 on
Council of 6 November 2001 on
Council of 6 November 2001 on
the Community code relating to
the Community code relating to
the Community code relating to
the Community code relating to
veterinary medicinal products (OJ
veterinary medicinal products (OJ
veterinary medicinal products (OJ
veterinary medicinal products (OJ
L 311, 28.11.2001, p. 1).
L 311, 28.11.2001, p. 1).
L 311, 28.11.2001, p. 1).
L 311, 28.11.2001, p. 1).
3. Regulation (EC) No 726/2004 of
3. Regulation (EC) No 726/2004 of
3. Regulation (EC) No 726/2004 of
3. Regulation (EC) No 726/2004 of
the European Parliament and of the
the European Parliament and of the
the European Parliament and of the
the European Parliament and of the
Council of 31 March 2004 laying
Council of 31 March 2004 laying
Council of 31 March 2004 laying
Council of 31 March 2004 laying
down Community procedures for
down Community procedures for
down Community procedures for
down Community procedures for
the authorisation and supervision
the authorisation and supervision
the authorisation and supervision
the authorisation and supervision
of medicinal products for human
of medicinal products for human
of medicinal products for human
of medicinal products for human
and veterinary use and establishing
and veterinary use and establishing
and veterinary use and establishing
and veterinary use and establishing
a European Medicines Agency (OJ
a European Medicines Agency (OJ
a European Medicines Agency (OJ
a European Medicines Agency (OJ
L 136, 30.4.2004, p. 1).
L 136, 30.4.2004, p. 1).
L 136, 30.4.2004, p. 1).
L 136, 30.4.2004, p. 1).
Text Origin: Commission
Proposal
Article 9(5), first subparagraph, point (b)
(b) a medicinal product for
(b) a medicinal product for
(b) a medicinal product for
(b) a medicinal product for
human use or in a veterinary human use or in a veterinary human use or in a veterinary human use or in a veterinary
medicinal product that is the medicinal product that is the medicinal product that is the medicinal product that is the
subject of an application for
subject of an application for
subject of an application for
subject of an application for
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a marketing authorisation;
a marketing authorisation;
a marketing authorisation;
a marketing authorisation;
Text Origin: Commission
Proposal
Article 9(5), first subparagraph, point (c)
(c) a medicinal product for
(c) a medicinal product for
(c) a medicinal product for
(c) a medicinal product for
human use or in a veterinary human use or in a veterinary human use or in a veterinary human use or in a veterinary
medicinal product whose
medicinal product whose
medicinal product whose
medicinal product whose
marketing authorisation has
marketing authorisation has
marketing authorisation has
marketing authorisation has
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been suspended by the
been suspended by the
been suspended by the
been suspended by the
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competent authority;
competent authority;
competent authority;
competent authority;
Text Origin: Commission
Proposal
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Article 9(5), first subparagraph, point (d)
(d) an unauthorised
(d) an unauthorised
(d) an unauthorised
(d) an unauthorised
medicinal product for human medicinal product for human medicinal product for human medicinal product for human
use as referred to in Article
use as referred to in Article
use as referred to in Article
use as referred to in Article
5(1) and (2) of Directive
5(1) and (2) of Directive
5(1) and (2) of Directive
5(1) and (2) of Directive
2001/83/EC or in a
2001/83/EC or in a
2001/83/EC or in a
2001/83/EC or in a
veterinary medicinal product veterinary medicinal product veterinary medicinal product veterinary medicinal product
prepared extemporaneously
prepared extemporaneously
prepared extemporaneously
prepared extemporaneously
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by a person authorised to do
by a person authorised to do
by a person authorised to do
by a person authorised to do
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so under national law in
so under national law in
so under national law in
so under national law in
accordance with Article
accordance with Article
accordance with Article
accordance with Article
10(1), point (c), of Directive 10(1), point (c), of Directive 10(1), point (c), of Directive 10(1), point (c), of Directive
2001/82/EC;
2001/82/EC;
2001/82/EC;
2001/82/EC;
Text Origin: Commission
Proposal
Article 9(5), first subparagraph, point (e)
(e) an investigational
(e) an investigational
(e) an investigational
(e) an investigational
medicinal product as defined medicinal product as defined medicinal product as defined medicinal product as defined
in Article 2, point (d), of
in Article 2, point (d), of
in Article 2, point (d), of
in Article 2, point (d), of
Directive 2001/20/EC of the Directive 2001/20/EC of the Directive 2001/20/EC of the Directive 2001/20/EC of the
European Parliament and of
European Parliament and of
European Parliament and of
European Parliament and of
the Council1.
the Council1.
the Council1.
the Council1.
_________
_________
_________
_________
1. Directive 2001/20/EC of the
1. Directive 2001/20/EC of the
1. Directive 2001/20/EC of the
1. Directive 2001/20/EC of the
European Parliament and of the
European Parliament and of the
European Parliament and of the
European Parliament and of the
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156
Council of 4 April 2001 on the
Council of 4 April 2001 on the
Council of 4 April 2001 on the
Council of 4 April 2001 on the
G
approximation of the laws,
approximation of the laws,
approximation of the laws,
approximation of the laws,
regulations and administrative
regulations and administrative
regulations and administrative
regulations and administrative
provisions of the Member States
provisions of the Member States
provisions of the Member States
provisions of the Member States
relating to the implementation of
relating to the implementation of
relating to the implementation of
relating to the implementation of
good clinical practice in the
good clinical practice in the
good clinical practice in the
good clinical practice in the
conduct of clinical trials on
conduct of clinical trials on
conduct of clinical trials on
conduct of clinical trials on
medicinal products for human use
medicinal products for human use
medicinal products for human use
medicinal products for human use
(OJ L 121, 1.5.2001, p. 34).
(OJ L 121, 1.5.2001, p. 34).
(OJ L 121, 1.5.2001, p. 34).
(OJ L 121, 1.5.2001, p. 34).
Text Origin: Commission
Proposal
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Article 9(5), second subparagraph
Where the information
Where the information
Where the information
Where the information
relates to marketing
relates to marketing
relates to marketing
relates to marketing
authorisations granted by
authorisations granted by
authorisations granted by
authorisations granted by
Member States, the Member Member States, the Member Member States, the Member Member States, the Member
States concerned shall
States concerned shall
States concerned shall
States concerned shall
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provide the European
provide the European
provide the European
provide the European
G
Medicines Agency with such Medicines Agency with such Medicines Agency with such Medicines Agency with such
information upon its request. information upon its request. information upon its request. information upon its request.
Text Origin: Commission
Proposal
Article 9(6)
6. The Agency shall,
6. The Agency shall,
6. The Agency shall,
6. The Agency shall,
without undue delay after
without undue delay after
without undue delay after
without undue delay after
the start of the drawing up of the start of the drawing up of the start of the drawing up of the start of the drawing up of
the initial report pursuant to
the initial report pursuant to
the initial report pursuant to
the initial report pursuant to
the first paragraph, request
the first paragraph, request
the first paragraph, request
the first paragraph, request
Europol to provide
Europol to provide
Europol to provide
Europol to provide
information on the
information on the
information on the
information on the
involvement of criminal
involvement of criminal
involvement of criminal
involvement of criminal
groups in the manufacture,
groups in the manufacture,
groups in the manufacture,
groups in the manufacture,
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distribution and distribution
distribution and distribution
distribution and distribution
distribution and distribution
methods, and trafficking of
methods, and trafficking of
methods, and trafficking of
methods, and trafficking of
the new psychoactive
the new psychoactive
the new psychoactive
the new psychoactive
substance, and in any use of
substance, and in any use of
substance, and in any use of
substance, and in any use of
the new psychoactive
the new psychoactive
the new psychoactive
the new psychoactive
substance.
substance.
substance.
substance.
Text Origin: Commission
Proposal
Article 9(7)
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7. The Agency shall,
7. The Agency shall,
7. The Agency shall,
7. The Agency shall,
without undue delay after
without undue delay after
without undue delay after
without undue delay after
the start of the drawing up of the start of the drawing up of the start of the drawing up of the start of the drawing up of
the initial report pursuant to
the initial report pursuant to
the initial report pursuant to
the initial report pursuant to
the first paragraph, request
the first paragraph, request
the first paragraph, request
the first paragraph, request
the European Chemicals
the European Chemicals
the European Chemicals
the European Chemicals
Agency, the European
Agency, the European
Agency, the European
Agency, the European
Centre for Disease
Centre for Disease
Centre for Disease
Centre for Disease
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159
Prevention and Control and
Prevention and Control and
Prevention and Control and
Prevention and Control and
G
the European Food Safety
the European Food Safety
the European Food Safety
the European Food Safety
Authority to provide the
Authority to provide the
Authority to provide the
Authority to provide the
information and data at their information and data at their information and data at their information and data at their
disposal on the new
disposal on the new
disposal on the new
disposal on the new
psychoactive substance.
psychoactive substance.
psychoactive substance.
psychoactive substance.
Text Origin: Commission
Proposal
Article 9(8)
8. The details of the
8. The details of the
8. The details of the
8. The details of the
cooperation between the
cooperation between the
cooperation between the
cooperation between the
Agency and the Union
Agency and the Union
Agency and the Union
Agency and the Union
decentralised agencies
decentralised agencies
decentralised agencies
decentralised agencies
referred to in paragraphs 5, 6 referred to in paragraphs 5, 6 referred to in paragraphs 5, 6 referred to in paragraphs 5, 6
and 7 shall be governed by
and 7 shall be governed by
and 7 shall be governed by
and 7 shall be governed by
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160
working arrangements. Such working arrangements. Such working arrangements. Such working arrangements. Such
G
working arrangements shall
working arrangements shall
working arrangements shall
working arrangements shall
be concluded in accordance
be concluded in accordance
be concluded in accordance
be concluded in accordance
with Article 53(2).
with Article 53(2).
with Article 53(2).
with Article 53(2).
Text Origin: Commission
Proposal
Article 9(9)
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161
9. The Agency shall respect 9. The Agency shall respect 9. The Agency shall respect 9. The Agency shall respect
G
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the conditions on use of the
the conditions on use of the
the conditions on use of the
the conditions on use of the
information, which are
information, which are
information, which are
information, which are
communicated to the
communicated to the
communicated to the
communicated to the
Agency, including
Agency, including
Agency, including
Agency, including
conditions on access to
conditions on access to
conditions on access to
conditions on access to
documents, information and
documents, information and
documents, information and
documents, information and
data security and protection
data security and protection
data security and protection
data security and protection
of confidential data,
of confidential data,
of confidential data,
of confidential data,
including sensitive data and
including sensitive data and
including sensitive data and
including sensitive data and
confidential business
confidential business
confidential business
confidential business
information of third parties.
information of third parties.
information of third parties.
information of third parties.
Text Origin: Commission
Proposal
Article 9(10)
10. The Agency shall
10. The Agency shall
10. The Agency shall
10. The Agency shall
submit the initial report to
submit the initial report to
submit the initial report to
submit the initial report to
the Commission and the
the Commission and the
the Commission and the
the Commission and the
Member States within five
Member States within five
Member States within five
Member States within five
weeks of making the
weeks of making the
weeks of making the
weeks of making the
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162
requests for information
requests for information
requests for information
requests for information
G
referred to in paragraphs 5, 6 referred to in paragraphs 5, 6 referred to in paragraphs 5, 6 referred to in paragraphs 5, 6
and 7.
and 7.
and 7.
and 7.
Text Origin: Commission
Proposal
Article 9(10), point (a)
(a) Where appropriate, the
Covered in line 113.
Agency shall disseminate
Possibly additionally address
the initial report to the
these elements in the recitals
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162a
relevant stakeholders,
[COM to suggest a wording] G
including the scientific
community, civil society
organisations and affected
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communities, for the
purpose of raising
awareness.
Article 9(11)
11. Where the Agency
11. Where the Agency
11. Where the Agency
11. Where the Agency
collects information on
collects information on
collects information on
collects information on
several new psychoactive
several new psychoactive
several new psychoactive
several new psychoactive
substances that it considers
substances that it considers
substances that it considers
substances that it considers
to be of similar chemical
to be of similar chemical
to be of similar chemical
to be of similar chemical
structure, it shall submit to
structure, it shall submit to
structure, it shall submit to
structure, it shall submit to
the Commission and to the
the Commission and to the
the Commission and to the
the Commission and to the
Member States individual
Member States individual
Member States individual
Member States individual
initial reports, or combined
initial reports, or combined
initial reports, or combined
initial reports, or combined
initial reports dealing with
initial reports dealing with
initial reports dealing with
initial reports dealing with
several new psychoactive
several new psychoactive
several new psychoactive
several new psychoactive
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163
G
substances, provided that the substances, provided that the substances, provided that the substances, provided that the
characteristics of each new
characteristics of each new
characteristics of each new
characteristics of each new
psychoactive substance are
psychoactive substance are
psychoactive substance are
psychoactive substance are
clearly identified, within six
clearly identified, within six
clearly identified, within six
clearly identified, within six
weeks of making the
weeks of making the
weeks of making the
weeks of making the
requests for information
requests for information
requests for information
requests for information
referred to in paragraphs 5, 6 referred to in paragraphs 5, 6 referred to in paragraphs 5, 6 referred to in paragraphs 5, 6
and 7.
and 7.
and 7.
and 7.
Text Origin: Commission
Proposal
Article 10
Article 10
Article 10
Article 10
Article 10
Risk assessment procedure
Risk assessment procedure
Risk assessment procedure
Risk assessment procedure
and report
and report
and report
and report
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Text Origin: Commission
Proposal
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Article 10(1)
1. Within two weeks of
1. Within two weeks of
1. Within two weeks of
1. Within two weeks of
receipt of an initial report as
receipt of an initial report as
receipt of an initial report as
receipt of an initial report as
referred to in Article 9(10),
referred to in Article 9(10),
referred to in Article 9(10),
referred to in Article 9(10),
the Commission may request the Commission may request the Commission may request the Commission may request
the Agency to assess the
the Agency to assess the
the Agency to assess the
the Agency to assess the
potential risks posed by the
potential risks posed by the
potential risks posed by the
potential risks posed by the
new psychoactive substance
new psychoactive substance
new psychoactive substance
new psychoactive substance
and to draw up a risk
and to draw up a risk
and to draw up a risk
and to draw up a risk
assessment report, where
assessment report, where
assessment report, where
assessment report, where
there are indications in the
there are indications in the
there are indications in the
there are indications in the
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165
initial report to believe that
initial report to believe that
initial report to believe that
initial report to believe that
G
the substance may pose
the substance may pose
the substance may pose
the substance may pose
severe public health risks
severe public health risks
severe public health risks
severe public health risks
and, where applicable,
and, where applicable,
and, where applicable,
and, where applicable,
severe social risks. The risk
severe social risks. The risk
severe social risks. The risk
severe social risks. The risk
assessment shall be carried
assessment shall be carried
assessment shall be carried
assessment shall be carried
out by the Scientific
out by the Scientific
out by the Scientific
out by the Scientific
Committee.
Committee.
Committee.
Committee.
Text Origin: Commission
Proposal
Article 10(2)
2. Within two weeks of
2. Within two weeks of
2. Within two weeks of
2. Within two weeks of
receipt of a combined initial
receipt of a combined initial
receipt of a combined initial
receipt of a combined initial
report as referred to in
report as referred to in
report as referred to in
report as referred to in
Article 9(11), the
Article 9(11), the
Article 9(11), the
Article 9(11), the
Commission may request the Commission may request the Commission may request the Commission may request the
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166
Agency to assess the
Agency to assess the
Agency to assess the
Agency to assess the
G
potential risks posed by
potential risks posed by
potential risks posed by
potential risks posed by
several new psychoactive
several new psychoactive
several new psychoactive
several new psychoactive
substances with a similar
substances with a similar
substances with a similar
substances with a similar
chemical structure and to
chemical structure and to
chemical structure and to
chemical structure and to
draw up a combined risk
draw up a combined risk
draw up a combined risk
draw up a combined risk
assessment report, where
assessment report, where
assessment report, where
assessment report, where
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there are indications in the
there are indications in the
there are indications in the
there are indications in the
combined initial report to
combined initial report to
combined initial report to
combined initial report to
believe that the substances
believe that the substances
believe that the substances
believe that the substances
may pose severe public
may pose severe public
may pose severe public
may pose severe public
health risks and, where
health risks and, where
health risks and, where
health risks and, where
applicable, severe social
applicable, severe social
applicable, severe social
applicable, severe social
risks. The combined risk
risks. The combined risk
risks. The combined risk
risks. The combined risk
assessment shall be carried
assessment shall be carried
assessment shall be carried
assessment shall be carried
out by the Scientific
out by the Scientific
out by the Scientific
out by the Scientific
Committee.
Committee.
Committee.
Committee.
Text Origin: Commission
Proposal
Article 10(3), introductory part
3. The risk assessment
3. The risk assessment
3. The risk assessment
3. The risk assessment
report or combined risk
report or combined risk
report or combined risk
report or combined risk
assessment report shall
assessment report shall
assessment report shall
assessment report shall
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contain:
contain:
contain:
contain:
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Text Origin: Commission
Proposal
Article 10(3), point (a)
(a) available information on (a) available information on (a) available information on (a) available information on
the chemical and physical
the chemical and physical
the chemical and physical
the chemical and physical
properties of the new
properties of the new
properties of the new
properties of the new
psychoactive substance and
psychoactive substance and
psychoactive substance and
psychoactive substance and
the methods and the
the methods and the
the methods and the
the methods and the
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168
G
precursors used for its
precursors used for its
precursors used for its
precursors used for its
manufacture or extraction;
manufacture or extraction;
manufacture or extraction;
manufacture or extraction;
Text Origin: Commission
Proposal
Article 10(3), point (b)
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(b) available information on (b) available information on (b) available information on (b) available information on
the pharmacological and
the pharmacological and
the pharmacological and
the pharmacological and
toxicological properties of
toxicological properties of
toxicological properties of
toxicological properties of
the new psychoactive
the new psychoactive
the new psychoactive
the new psychoactive
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169
G
substance;
substance;
substance;
substance;
Text Origin: Commission
Proposal
Article 10(3), point (c)
(c) an analysis of the health
(c) an analysis of the health
(c) an analysis of the health
(c) an analysis of the health
Covered under "health risks
risks associated with the new risks associated with the new risks associated with the new risks associated with the new / acute toxicity
psychoactive substance, in
psychoactive substance, in
psychoactive substance, in
psychoactive substance, in
particular with respect to its
particular with respect to its
particular with respect to its
particular with respect to its
acute and chronic toxicity,
acute and chronic toxicity,
acute and chronic toxicity,
acute and chronic toxicity,
abuse liability, dependence-
abuse liability, dependence-
abuse liability, dependence-
abuse liability, dependence-
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170
producing potential, and
producing potential, and
producing potential, and
producing potential, and
G
physical, mental and
physical, mental and
physical, mental and
physical, mental and
behavioural effects;
behavioural effects
and in
behavioural effects;
behavioural effects;
relation to drug-related
deaths, including where
Text Origin: Commission
Proposal
they are a result of
overdoses;
Article 10(3), point (d)
(d) an analysis of the social
(d) an analysis of the social
(d) an analysis of the social
(d) an analysis of the social
"Social marginalisation"
risks associated with the new risks associated with the new risks associated with the new risks associated with the new could be covered in a recital
psychoactive substance – in
psychoactive substance – in
psychoactive substance – in
psychoactive substance – in
relating to social aspects
particular its impact on
particular its impact on
particular its impact on
particular its impact on
[COM to suggest a wording]
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171
social functioning, public
social functioning
and social social functioning, public
social functioning, public
G
order and criminal activities,
marginalisation, public
order and criminal activities, order and criminal activities,
and the involvement of
order and criminal activities, and the involvement of
and the involvement of
criminal groups in the
and the involvement of
criminal groups in the
criminal groups in the
manufacture, distribution
criminal groups in the
manufacture, distribution
manufacture, distribution
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and distribution methods,
manufacture, distribution
and distribution methods,
and distribution methods,
and trafficking of the new
and distribution methods,
and trafficking of the new
and trafficking of the new
psychoactive substance;
and trafficking of the new
psychoactive substance;
psychoactive substance;
psychoactive substance;
Text Origin: Commission
Proposal
Article 10(3), point (e)
(e) available information on (e) available information on (e) available information on (e) available information on
the extent and patterns of use the extent and patterns of use the extent and patterns of use the extent and patterns of use
of the new psychoactive
of the new psychoactive
of the new psychoactive
of the new psychoactive
substance, its availability
substance, its availability
substance, its availability
substance, its availability
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172
and potential for diffusion
and potential for diffusion
and potential for diffusion
and potential for diffusion
G
within the Union;
within the Union;
within the Union;
within the Union;
Text Origin: Commission
Proposal
Article 10(3), point (f)
(f) available information on
(f) available information on
(f) available information on
(f) available information on
the commercial and
the commercial and
the commercial and
the commercial and
industrial use of the new
industrial use of the new
industrial use of the new
industrial use of the new
psychoactive substance, the
psychoactive substance, the
psychoactive substance, the
psychoactive substance, the
extent of such use, as well as extent of such use, as well as extent of such use, as well as extent of such use, as well as
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173
G
its use for scientific research its use for scientific research its use for scientific research its use for scientific research
and development purposes;
and development purposes;
and development purposes;
and development purposes;
Text Origin: Commission
Proposal
Article 10(3), point (fa)
(fa) available information
No evidence-based
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173a
on recommended evidence-
responses might be available G
based demand reduction,
as this concerns new
harm reduction and
substances
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recovery responses to
minimise the risks and
harms associated with the
new psychoactive
substance;
Article 10(3), point (g)
(g) other relevant
(g) other relevant
(g) other relevant
(g) other relevant
information, where
information, where
information, where
information, where
available.
available.
available.
available.
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G
Text Origin: Commission
Proposal
Article 10(4), first subparagraph
4. The Scientific Committee 4. The Scientific Committee 4. The Scientific Committee 4. The Scientific Committee
shall assess the risks posed
shall assess the risks posed
shall assess the risks posed
shall assess the risks posed
by the new psychoactive
by the new psychoactive
by the new psychoactive
by the new psychoactive
substance or group of new
substance or group of new
substance or group of new
substance or group of new
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G
psychoactive substances.
psychoactive substances.
psychoactive substances.
psychoactive substances.
Text Origin: Commission
Proposal
Article 10(4), second subparagraph
The Commission, the
The Commission, the
The Commission, the
The Commission, the
Agency, Europol and the
Agency, Europol and the
Agency, Europol and the
Agency, Europol and the
European Medicines Agency European Medicines Agency European Medicines Agency European Medicines Agency
shall each have the right to
shall each have the right to
shall each have the right to
shall each have the right to
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G
appoint two observers.
appoint two observers.
appoint two observers.
appoint two observers.
Text Origin: Commission
Proposal
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Article 10(5)
5. The Scientific Committee 5. The Scientific Committee 5. The Scientific Committee 5. The Scientific Committee
shall carry out the risk
shall carry out the risk
shall carry out the risk
shall carry out the risk
assessment on the basis of
assessment on the basis of
assessment on the basis of
assessment on the basis of
the available information
the available information
the available information
the available information
and of any other relevant
and of any other relevant
and of any other relevant
and of any other relevant
scientific evidence. It shall
scientific evidence. It shall
scientific evidence. It shall
scientific evidence. It shall
take into account all
take into account all
take into account all
take into account all
opinions held by its
opinions held by its
opinions held by its
opinions held by its
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members. The Agency shall
members. The Agency shall
members. The Agency shall
members. The Agency shall
G
organise the risk assessment
organise the risk assessment
organise the risk assessment
organise the risk assessment
procedure, including
procedure, including
procedure, including
procedure, including
identifying future
identifying future
identifying future
identifying future
information needs and
information needs and
information needs and
information needs and
relevant studies.
relevant studies.
relevant studies.
relevant studies.
Text Origin: Commission
Proposal
Article 10(6)
6. The Agency shall submit
6. The Agency shall submit
6. The Agency shall submit
6. The Agency shall submit
the risk assessment report or the risk assessment report or the risk assessment report or the risk assessment report or
the combined risk
the combined risk
the combined risk
the combined risk
assessment report to the
assessment report to the
assessment report to the
assessment report to the
Commission and the
Commission and the
Commission and the
Commission and the
Member States within six
Member States within six
Member States within six
Member States within six
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178
weeks of receipt of the
weeks of receipt of the
weeks of receipt of the
weeks of receipt of the
G
request from the
request from the
request from the
request from the
Commission to draw up a
Commission to draw up a
Commission to draw up a
Commission to draw up a
risk assessment report.
risk assessment report.
risk assessment report.
risk assessment report.
Text Origin: Commission
Proposal
Article 10(6), point (a)
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178a
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(a) Where appropriate, the
Covered in line 113.
Agency shall disseminate
Possibly additionally address
the risk assessment report
these elements in the recitals
or the combined risk
[COM to suggest a wording,
assessment report to the
as for line 162a]
relevant stakeholders,
including the scientific
community, civil society
organisations and affected
communities, for
awareness-raising purposes.
Article 10(7)
7. Upon receipt of a duly
7. Upon receipt of a duly
7. Upon receipt of a duly
7. Upon receipt of a duly
reasoned request of the
reasoned request of the
reasoned request of the
reasoned request of the
Agency, the Commission
Agency, the Commission
Agency, the Commission
Agency, the Commission
may extend the period for
may extend the period for
may extend the period for
may extend the period for
completion of the risk
completion of the risk
completion of the risk
completion of the risk
assessment or combined risk assessment or combined risk assessment or combined risk assessment or combined risk
assessment to allow for
assessment to allow for
assessment to allow for
assessment to allow for
additional research and data
additional research and data
additional research and data
additional research and data
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179
collection to take place. That collection to take place. That collection to take place. That collection to take place. That
G
request shall contain
request shall contain
request shall contain
request shall contain
information on the period of
information on the period of
information on the period of
information on the period of
time needed to complete the
time needed to complete the
time needed to complete the
time needed to complete the
risk assessment or combined risk assessment or combined risk assessment or combined risk assessment or combined
risk assessment.
risk assessment.
risk assessment.
risk assessment.
Text Origin: Commission
Proposal
Article 10(8)
8. The Agency shall also
8. The Agency shall also
8. The Agency shall also
8. The Agency shall also
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180
provide timely rapid risk
provide timely rapid risk
provide timely rapid risk
provide timely rapid risk
G
assessments, in accordance
assessments, in accordance
assessments, in accordance
assessments, in accordance
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with Article 20 of
with Article 20 of
with Article 20 of
with Article 20 of
Regulation (EU) …/… on
Regulation (EU) …/… on
Regulation (EU) …/… on
Regulation (EU) …/… on
serious cross-border threats
serious cross-border threats
serious cross-border threats
serious cross-border threats
to health and repealing
to health and repealing
to health and repealing
to health and repealing
Decision No 1082/2013/EU, Decision No 1082/2013/EU, Decision No 1082/2013/EU, Decision No 1082/2013/EU,
in the case of a threat
in the case of a threat
in the case of a threat
in the case of a threat
referred to in points (b) of
referred to in points (b) of
referred to in points
point (b) referred to in
pointspoint (b)
Article 2(1) of that
Article 2(1) of that
of Article 2(1) of that
of Article 2(1) of that
Regulation, where the threat
Regulation, where the threat
Regulation, where the threat
Regulation, where the threat
falls under the mandate of
falls under the mandate of
falls under the mandate of
falls under the mandate of
the Agency.
the Agency.
the Agency.
the Agency.
Text Origin: Council
Mandate
Article 11
Article 11
Article 11
Article 11
Article 11
Exclusion from risk
Exclusion from risk
Exclusion from risk
Exclusion from risk
assessment
assessment
assessment
assessment
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181
G
Text Origin: Commission
Proposal
Article 11(1)
1. No risk assessment shall
1. No risk assessment shall
1. No risk assessment shall
1. No risk assessment shall
be carried out where the new be carried out where the new be carried out where the new be carried out where the new
psychoactive substance is at
psychoactive substance is at
psychoactive substance is at
psychoactive substance is at
an advanced stage of
an advanced stage of
an advanced stage of
an advanced stage of
assessment within the United assessment within the United assessment within the United assessment within the United
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182
Nations system, namely
Nations system, namely
Nations system, namely
Nations system, namely
G
once the World Health
once the World Health
once the World Health
once the World Health
Organisation Expert
Organisation Expert
Organisation Expert
Organisation Expert
Committee on Drug
Committee on Drug
Committee on Drug
Committee on Drug
Dependence has published
Dependence has published
Dependence has published
Dependence has published
its critical review together
its critical review together
its critical review together
its critical review together
with a written
with a written
with a written
with a written
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recommendation, except
recommendation, except
recommendation, except
recommendation, except
where there are sufficient
where there are sufficient
where there are sufficient
where there are sufficient
data and information
data and information
data and information
data and information
available to suggest the need available to suggest the need available to suggest the need available to suggest the need
for a risk assessment report
for a risk assessment report
for a risk assessment report
for a risk assessment report
at Union level, the reasons
at Union level, the reasons
at Union level, the reasons
at Union level, the reasons
for which shall be indicated
for which shall be indicated
for which shall be indicated
for which shall be indicated
in the initial report.
in the initial report.
in the initial report.
in the initial report.
Text Origin: Commission
Proposal
Article 11(2)
2. No risk assessment shall
2. No risk assessment shall
2. No risk assessment shall
2. No risk assessment shall
be carried out where,
be carried out where,
be carried out where,
be carried out where,
following an assessment
following an assessment
following an assessment
following an assessment
within the United Nations
within the United Nations
within the United Nations
within the United Nations
system, it has been decided
system, it has been decided
system, it has been decided
system, it has been decided
not to schedule the new
not to schedule the new
not to schedule the new
not to schedule the new
psychoactive substance,
psychoactive substance,
psychoactive substance,
psychoactive substance,
except where there are
except where there are
except where there are
except where there are
sufficient data and
sufficient data and
sufficient data and
sufficient data and
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183
G
information available to
information available to
information available to
information available to
suggest the need for a risk
suggest the need for a risk
suggest the need for a risk
suggest the need for a risk
assessment report at Union
assessment report at Union
assessment report at Union
assessment report at Union
level, the reasons for which
level, the reasons for which
level, the reasons for which
level, the reasons for which
shall be indicated in the
shall be indicated in the
shall be indicated in the
shall be indicated in the
initial report.
initial report.
initial report.
initial report.
Text Origin: Commission
Proposal
Article 11(3), introductory part
3. No risk assessment shall
3. No risk assessment shall
3. No risk assessment shall
3. No risk assessment shall
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184
be carried out where the new be carried out where the new be carried out where the new be carried out where the new
G
psychoactive substance is an psychoactive substance is an psychoactive substance is an psychoactive substance is an
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active substance in:
active substance in:
active substance in:
active substance in:
Text Origin: Commission
Proposal
Article 11(3), point (a)
(a) a medicinal product for
(a) a medicinal product for
(a) a medicinal product for
(a) a medicinal product for
human use or in a veterinary human use or in a veterinary human use or in a veterinary human use or in a veterinary
medicinal product that has
medicinal product that has
medicinal product that has
medicinal product that has
obtained a marketing
obtained a marketing
obtained a marketing
obtained a marketing
authorisation in accordance
authorisation in accordance
authorisation in accordance
authorisation in accordance
with Directive 2001/83/EC,
with Directive 2001/83/EC,
with Directive 2001/83/EC,
with Directive 2001/83/EC,
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185
G
Directive 2001/82/EC or
Directive 2001/82/EC or
Directive 2001/82/EC or
Directive 2001/82/EC or
Regulation (EC) No
Regulation (EC) No
Regulation (EC) No
Regulation (EC) No
726/2004;
726/2004;
726/2004;
726/2004;
Text Origin: Commission
Proposal
Article 11(3), point (b)
(b) a medicinal product for
(b) a medicinal product for
(b) a medicinal product for
(b) a medicinal product for
human use or in a veterinary human use or in a veterinary human use or in a veterinary human use or in a veterinary
medicinal product that is the medicinal product that is the medicinal product that is the medicinal product that is the
subject of an application for
subject of an application for
subject of an application for
subject of an application for
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186
G
a marketing authorisation;
a marketing authorisation;
a marketing authorisation;
a marketing authorisation;
Text Origin: Commission
Proposal
Article 11(3), point (c)
(c) a medicinal product for
(c) a medicinal product for
(c) a medicinal product for
(c) a medicinal product for
human use or in a veterinary human use or in a veterinary human use or in a veterinary human use or in a veterinary
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187
medicinal product whose
medicinal product whose
medicinal product whose
medicinal product whose
G
marketing authorisation has
marketing authorisation has
marketing authorisation has
marketing authorisation has
been suspended by the
been suspended by the
been suspended by the
been suspended by the
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competent authority;
competent authority;
competent authority;
competent authority;
Text Origin: Commission
Proposal
Article 11(3), point (d)
(d) an investigational
(d) an investigational
(d) an investigational
(d) an investigational
medicinal product as defined medicinal product as defined medicinal product as defined medicinal product as defined
in Article 2, point (d), of
in Article 2, point (d), of
in Article 2, point (d), of
in Article 2, point (d), of
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188
Directive 2001/20/EC.
Directive 2001/20/EC.
Directive 2001/20/EC.
Directive 2001/20/EC.
G
Text Origin: Commission
Proposal
Article 12
Article 12
Article 12
Article 12
Article 12
Threat assessment and
Health and security threat
Health and security threat
Health and security threat
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189
preparedness
assessment and preparedness assessment and preparedness assessment and preparedness
G
Text Origin: EP Mandate
Article 12(1)
1. The Agency shall
1. The Agency shall
1. The Agency shall
1. The Agency shall
Social matters / aspects to
develop a strategic general
develop a strategic
develop a strategic
develop a strategic
be aligned with other
threat assessment capability
generalevidence-based
evidence-based general
generalevidence-based
provisions, in line with
to identify at an early stage
health and security threat
health and security threat
health and security threat
advice from lawyer-linguists
new developments of the
assessment capability to
assessment capability to
assessment capability to
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190
drugs phenomenon that have identify at an early stage
identify at an early stage
identify at an early stage
G
a potential to impact
new developments of the
new developments of the
new developments of the
negatively on public health,
drugs phenomenon that have drugs phenomenon
situation drugs phenomenon that have
safety and security and,
a potential to impact
that have a potential to
a potential to impact
through doing so, to help
negatively on public health,
impact negatively on public
negatively on
public
increase the preparedness of
social matters, safety and
health
health, social aspects,
healthhealth, social matters,
the relevant stakeholders to
security
in the Union and,
safety and
or security
in the
safety
andor security
in the
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respond to new threats in a
through doing so, to help
Union and, through doing
Union and, through doing
timely and effective manner. increase the preparedness of
so, to help increase the
so, to help increase the
the relevant stakeholders to
preparedness of the relevant
preparedness of the relevant
respond to new threats in a
stakeholders to respond to
stakeholders to respond to
timely and effective manner. new threats in a timely and
new threats in
a timely and
effective
an efficient and
effectivean effective and
timely manner.
timely manner.
Text Origin: Council
Mandate
Article 12(2), first subparagraph
2. The Agency shall set out
2. The Agency shall set out
a set of criteria to evaluate
a set of
objective criteria to
deleted
deleted
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191
when to trigger a threat
evaluate when to trigger a
G
assessment.
health and security threat
assessment.
Article 12(2), second subparagraph
A threat assessment may be
A
health and security threat A threat assessment may be
A
health and security threat
launched by the Agency on
assessment may be launched launched by the Agency on
assessment may be launched
its own initiative based on an by the Agency on its own
its own initiative based on an by the Agency on its own
internal appraisal of signals
initiative based on an
internal appraisal of signals
initiative based on an
arising from routine
internal appraisal of signals
arising from routine
internal appraisal of signals
monitoring, research or other arising from routine
monitoring, research or other arising from routine
appropriate information
monitoring, research or other appropriate information
monitoring, research or other
sources. A threat assessment appropriate information
sources. A threat assessment appropriate information
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192
G
may also be launched at the
sources. A
health and
may also be launched at the
sources. A
health and
request of the Commission
security threat assessment
request of the Commission
security threat assessment
or of a Member State, if the
may also be launched at the
or of a Member State, if the
may also be launched at the
defined criteria are met.
request of the Commission
defined criteria
criteria set
request of the Commission
or of a Member State, if the
out in paragraph 1 are met. or of a Member State, if the
defined criteria are met.
defined criteriacriteria set
out in paragraph 1 are met.
Text Origin: EP Mandate
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Article 12(3)
3. A threat assessment shall
3. A
health and security
3. A threat assessment shall
3. A
health and security
consist of a rapid evaluation
threat assessment shall
consist of a rapid evaluation
threat assessment shall
of existing information and,
consist of a rapid evaluation
of existing information and,
consist of a rapid evaluation
where necessary, the
of existing information and,
where necessary, the
of existing information and,
collection of new
where necessary, the
collection of new
where necessary, the
information through the
collection of new
information through the
collection of new
Agency’s information
information through the
Agency’s information
information through the
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193
G
networks. The Agency shall
Agency’s information
networks. The Agency shall
Agency’s information
develop appropriate
networks. The Agency shall
develop appropriate
networks. The Agency shall
scientific rapid assessment
develop appropriate
scientific rapid assessment
develop appropriate
methods.
scientific rapid assessment
methods.
scientific rapid assessment
methods.
methods.
Text Origin: EP Mandate
Article 12(4)
4. The threat assessment
4. The
health and security
4. The threat assessment
4. The
health and security
report shall describe the
threat assessment report
report shall describe the
threat assessment report
identified threat, the current
shall describe the identified
identified threat, the current
shall describe the identified
situation based on available
threat, the current situation
situation based on available
threat, the current situation
evidence, the potential
based on available evidence, evidence, the potential
based on available evidence,
outcomes in the event of no
the potential outcomes in the outcomes in the event of no
the potential outcomes in the
action, and set out options
event of no action, and set
action, and set out options
event of no action, and set
for preparedness and
out options for preparedness for preparedness and
out options for preparedness
Y
194
response that may be
and response that may be
response that may be
and response that may be
Y
adopted to mitigate the
adopted to mitigate
and to
adopted to mitigate the
adopted to mitigate
and to
threat identified. It may also
respond to the threat
threat identified. It may also
respond to the threat
contain potential follow-up
identified
, including
contain potential follow-up
identified
, including, where
measures to be adopted. The
evidence-based
measures to be adopted. The
possible, evidence-based
threat assessment report
interventions on demand
threat assessment report
interventions on demand
shall be sent to the
reduction, risk and harm
shall be sent to the
reduction, risk and harm
Commission and the
reduction and recovery. It
Commission and the
reduction and recovery. It
Member States, as
may also contain potential
Member States, as
may also contain potential
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appropriate.
follow-up measures to be
appropriate.
follow-up measures
. The
adopted. The
health and
health and security to be
security threat assessment
adopted. The threat
report shall be sent to the
assessment report shall be
Commission and
to the
sent to the Commission and
Member States
. Where
to the Member States
. [The
appropriate, the Agency
Agency shall make
shall disseminate health
summaries of those reports
and security threat
publicly available on its
assessment reports to
website, where, as
relevant stakeholders,
appropriate
, except where
including the scientific
prevented to do so by the
community, healthcare
use of sensitive non-
professionals, civil society
classified and classified
organisations and affected
data.
]
communities, as
appropriate.
The Agency
Text Origin: EP Mandate
shall make summaries of
those reports publicly
available on its website.
Article 12(5)
5. The Agency shall
5. The Agency shall
5. The Agency shall
5. The Agency shall
cooperate closely with other
cooperate closely with
cooperate closely with
cooperate closely with
Union decentralised
Member States, other Union
Member States, other
Member States, other Union
agencies and bodies, Union
decentralised agencies and
Union decentralised agencies
decentralised agencies and
and international
bodies, Unionbodies, offices and bodies, Union and
bodies, Unionbodies, offices
organisations in carrying out
and agencies and
international organisations in
and agencies and
a threat assessment by
international organisations in carrying out a threat
international organisations in
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195
involving them in the
carrying out a
health and
assessment by involving
carrying out a
health and
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assessment as appropriate.
security threat assessment by them in the assessment as
security threat assessment by
Where the potential threat is
involving them in the
appropriate. Where the
involving them in the
already subject to an
assessment as appropriate.
potential threat is already
assessment as appropriate.
analysis under another
Where the potential threat is
subject to an analysis under
Where the potential threat is
Union mechanism, the
already subject to an
another Union mechanism,
already subject to an
Agency shall not carry out a
analysis under another
the Agency shall not carry
analysis under another
threat assessment.
Union mechanism, the
out a threat assessment.
Union mechanism, the
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Agency shall not carry out a
Agency shall not carry out a
health and security threat
health and security threat
assessment.
assessment.
Text Origin: EP Mandate
Article 12(6)
6. With the agreement of the 6. With the agreement of the 6. With the agreement of the 6. With the agreement of the Social matters / socials
Commission, the Agency
Commission, the Agency
Commission, the Agency
Commission, the Agency
aspects tbc
shall conduct threat
shall conduct
health and
shall conduct threat
shall conduct
health and
assessments on drug related
security threat assessments
assessments on drug related
security threat assessments
threats emerging from
on drug related threats
threats emerging from
on drug related threats
outside the Union, which
emerging from outside the
outside the Union, which
emerging from outside the
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196
have the potential to impact
Union, which have the
have the potential to impact
Union, which have the
G
public health, safety and
potential to impact public
public health
health, social
potential to impact
public
security within the Union.
health
, social matters, safety
aspects, safety and
or
healthhealth, social matters,
and security within the
security within the Union.
safety
andor security within
Union.
the Union.
Text Origin: EP Mandate
Article 12(6), point (a)
(a) The Agency shall
Covered in line 196b
monitor the evolution of
new developments of the
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196a
drugs phenomenon as
G
referred to in paragraph 1
and update the threat
assessments accordingly.
Article 12(6a)
6a. The Agency shall,
6a. The Agency shall
G
196b
when needed, update the
monitor the evolution of the
G
threat assessments and to
situation and, when
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monitor the evolution of
necessary, update the threat
the situation.
assessments accordingly.
Text Origin: Council
Mandate
Article 13
Article 13
Article 13
Article 13
Article 13
European drug alert system
European drug alert system
European drug alert system
European drug alert system
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197
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Text Origin: Commission
Proposal
Article 13(1)
1. The Agency shall set up
1. The Agency shall set up
1. The Agency shall set up
1. The Agency shall set up
and manage a rapid
and manage a rapid
and manage a rapid
and manage a rapid
European drug alert system.
European drug alert system.
European drug alert system
,
European drug alert system
,
complementing and
complementing and without
without prejudice to the
prejudice to the relevant
relevant national alert
national alert systems. The
systems. The system is
system is complementary to
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198
G
complementary to the
the Early Warning System
Early Warning System on
on the new psychoactive
the new psychoactive
substances, referred to in
substances, referred to in
Articles 8-11.
Articles 8-11.
Text Origin: Council
Mandate
Article 13(2), introductory part
2. Member States shall
2. Member States shall
2. Member States
The
2.
Member StatesThe
immediately notify the
immediately notify the
national focal points, in
national focal points[, in
Y
199
Agency of any information
Agency of any information
cooperation with the
cooperation with the
Y
relating to the appearance of relating to the appearance of
relevant national
relevant national competent
a serious direct or indirect
a serious direct or indirect
competent authorities, shall
authorities,] shall
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drug-related risk to human
drug-related risk to human
immediately notify the
immediately notify the
health, safety or security as
health,
social aspects, safety Agency of any information
Agency of any information
well as any information that
or security as well as any
relating to the appearance of relating to the appearance of
may be useful for
information that may be
a serious direct or indirect
a serious direct or indirect
coordinating a response
useful for coordinating a
drug-related risk to human
drug-related risk to
human
whenever they become
response whenever they
health
, social aspects, safety health
, social aspects, safety
aware of such information,
become aware of such
or security as well as any
or security as well as any
such as:
information, such as:
information that may be
information that may be
useful for coordinating a
useful for coordinating a
response whenever they
response whenever they
become aware of such
become aware of such
information, such as:
information, such as:
Text Origin: Council
Mandate
Article 13(2), point (a)
(a) the type and origin of the (a) the type and origin of the (a) the type and origin of the (a) the type and origin of the
risk;
risk;
risk;
risk;
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200
G
Text Origin: Commission
Proposal
Article 13(2), point (b)
(b) the date and place of the (b) the date and place of the (b) the date and place of the (b) the date and place of the
event involving the risk;
event involving the risk;
event involving the risk;
event involving the risk;
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201
G
Text Origin: Commission
Proposal
Article 13(2), point (c)
(c) the means of exposure,
(c) the means of exposure,
(c) the means of exposure,
(c) the means of exposure,
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202
transmission or
transmission or
transmission or
transmission or
G
dissemination;
dissemination;
dissemination;
dissemination;
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Text Origin: Commission
Proposal
Article 13(2), point (d)
(d) analytical and
(d) analytical and
(d) analytical and
(d) analytical and
toxicological data;
toxicological data;
toxicological data;
toxicological data;
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203
G
Text Origin: Commission
Proposal
Article 13(2), point (e)
(e) identification methods;
(e) identification methods;
(e) identification methods;
(e) identification methods;
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204
G
Text Origin: Commission
Proposal
Article 13(2), point (f)
(f) public health risks;
(f) public health risks;
(f) public health risks;
(f)
public health risks;
[Last line discussed on
1/2/2023]
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Text Origin: Council
Mandate
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******
Financial provisions
Article 36
Article 36
Article 36
Article 36
Article 36
Budget
Budget
Budget
Budget
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427
G
Text Origin: Commission
Proposal
Article 36(1)
1. Estimates of all revenue
1. Estimates of all revenue
1. Estimates of all revenue
1. Estimates of all revenue
and expenditure for the
and expenditure for the
and expenditure for the
and expenditure for the
Agency shall be prepared
Agency shall be prepared
Agency shall be prepared
Agency shall be prepared
each financial year,
each financial year,
each financial year,
each financial year,
corresponding to the
corresponding to the
corresponding to the
corresponding to the
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428
calendar year, and shall be
calendar year, and shall be
calendar year, and shall be
calendar year, and shall be
G
shown in the Agency's
shown in the Agency's
shown in the Agency's
shown in the Agency's
budget.
budget.
budget.
budget.
Text Origin: Commission
Proposal
Article 36(2)
2. The Agency's budget
2. The Agency's budget
2. The Agency's budget
2. The Agency's budget
Possible link to COM
shall be balanced in terms of shall be balanced in terms of shall be balanced in terms of shall be balanced in terms of declaration in relation to
revenue and of expenditure.
revenue and of expenditure.
revenue and of expenditure.
revenue and of expenditure.
recital 29 and other budget-
The Agency shall be
related elements
awarded an adequate
Text Origin: Commission
Y
429
Proposal
budget to ensure sufficient
Y
staff and equipment in
order to allow it to achieve
the objectives and tasks set
out in this Regulation.
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Article 36(3), introductory part
3. Without prejudice to
3. Without prejudice to
3. Without prejudice to
3. Without prejudice to
other resources, the
other resources, the
other resources, the
other resources, the
Agency's revenue shall
Agency's revenue shall
Agency's revenue shall
Agency's revenue shall
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430
comprise:
comprise:
comprise:
comprise:
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Text Origin: Commission
Proposal
Article 36(3), point (a)
(a) a contribution from the
(a) a contribution from the
(a) a contribution from the
(a) a contribution from the
Union entered in the general Union entered in the general Union entered in the general Union entered in the general
budget of the European
budget of the European
budget of the European
budget of the European
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431
Union;
Union;
Union;
Union;
G
Text Origin: Commission
Proposal
Article 36(3), point (b)
(b) any voluntary financial
(b) any voluntary financial
(b) any voluntary financial
(b) any voluntary financial
contribution from the
contribution from the
contribution from the
contribution from the
Member States;
Member States;
Member States;
Member States;
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432
G
Text Origin: Commission
Proposal
Article 36(3), point (c)
(c) the fees paid for services (c) the fees paid for services (c) the fees paid for services (c) the fees paid for services
rendered in accordance with
rendered in accordance with
rendered in accordance with
rendered in accordance with
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433
Article 37; and
Article 37;
and
Article 37; and
Article 37;
and
G
Text Origin: EP Mandate
Article 36(3), point (d)
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(d) any financial
(d) any financial
(d) any financial
(d) any financial
contributions from the
contributions from the
contributions from the
contributions from the
organisations and bodies and organisations and bodies and organisations and bodies and organisations and bodies and
third countries referred to in
third countries referred to in
third countries referred to in
third countries referred to in
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434
G
Articles 53 and 54,
Articles 53 and 54,
Articles 53 and 54,
Articles 53 and 54,
respectively.
respectively
.; and
respectively.
respectively
.; and
Text Origin: EP Mandate
Article 36(3), point (da)
(da) Union funding under
(da) Union funding under
To align this wording with
indirect management or in
indirect management or in
texts of other Regulations.
the form of ad hoc grants in
the form of ad hoc grants in
accordance with the
accordance with the
financial rules applicable to
financial rules applicable to
Y
434a
the Agency and with the
the Agency and with the
Y
provisions of the relevant
provisions of the relevant
instruments supporting the
instruments supporting the
policies of the Union.
policies of the Union.
Text Origin: EP Mandate
Article 36(3a)
3a. The amount and origin
3a. The amount and origin
of any revenue as referred
of any revenue as referred
to in points (b), (c) (d) and
to in points (b), (c) (d) and
(da) of the first
(da) of the first
subparagraph of this
subparagraph of this
Y
434b
paragraph shall be included
paragraph shall be included
Y
in the annual accounts of
in the annual accounts of
the Agency and clearly
the Agency and clearly
detailed in the annual
detailed in the annual
report on the Agency's
report on the Agency's
budgetary and financial
budgetary and financial
management referred to in
management referred to in
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Article 40(2).
Article 40(2).
Article 36 - paragraph
Text Origin: EP Mandate
3 - subparagraph 1 a
(new)
Article 36(4)
4. The expenditure of the
4. The expenditure of the
4. The expenditure of the
4. The expenditure of the
Agency shall include staff
Agency shall include staff
Agency shall include staff
Agency shall include staff
remuneration, administrative remuneration, administrative remuneration, administrative remuneration, administrative
and infrastructure expenses,
and infrastructure expenses,
and infrastructure expenses,
and infrastructure expenses,
and operating costs. The
and operating costs. The
and operating costs. The
and operating costs. The
operating costs may include
operating costs may include
operating costs may include
operating costs may include
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435
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expenditure in support of the expenditure in support of the expenditure in support of the expenditure in support of the
national focal points, as
national focal points, as
national focal points, as
national focal points, as
referred to in Article 32(7).
referred to in Article 32(7).
referred to in Article 32(7).
referred to in Article 32(7).
Text Origin: Commission
Proposal
Article 37
Article 37
Article 37
Article 37
Article 37
Fees
Fees
Fees
Fees
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436
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Text Origin: Commission
Proposal
Article 37(1), introductory part
1. The Agency may charge
1. The Agency may charge
1. The Agency may charge
Informal COM suggestion
fees for the following:
fees for the following
fees for the following:
(see together with recital
services where they are
30):
Y
437
clearly separated from the
Y
tasks of the Agency laid
1. The Agency may
decide
down in this Regulation:
to deliver and charge fees
for the following
additional
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services other than those
laid down in this
Regulation: ***
Alternative suggestions by
the Presidency, following
the consultation with the
Legal Service:
1. The Agency may
decide
to deliver and charge fees
for the following
additional
services delivered upon
request, other than those
laid down in this
Regulation:
Article 37(1), point (a)
(a) training programmes;
(a) training programmes
(a) training
Informal COM suggestion:
Y
438
other than those referred to
programmes
pursuant to
Y
in Article 19;
Article 19;
(a)
customised training;
Article 37(1), point (b)
(b) certain support activities (b)
certainnecessary and
(b) certain support activities
Informal COM suggestion:
for Member States that have
duly justified support
for Member States that have
not been identified as a
activities for Member States
not been identified as a
(b) certain support activities
priority but could be
other than those provided
priority but could be
for Member States that have
Y
439
beneficially conducted if
for in this Regulation that
beneficially conducted if
not been identified as a
Y
supported by national
have not been identified as a supported by national
priority but could be
resources;
priority but could be
resources;
beneficially conducted if
beneficially conducted if
supported by national
supported by national
resources;
resources;
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Article 37(1), point (c)
(c) capacity-building
(c) capacity-building
(c) capacity-building
(c) capacity-building
Informal COM suggestion:
programmes for third
programmes for third
programmes for third
programmes
and training
countries, which are not
countries, which are not
countries, which are not
for third countries, which are (c) capacity-building
covered by separate
covered by separate
covered by separate
not covered by separate
programmes for third
Y
440
Y
dedicated Union funding;
dedicated Union funding;
dedicated Union funding;
dedicated Union funding;
countries which are not
covered by separate
Text Origin: Commission
dedicated Union funding;
Proposal
Article 37(1), point (d)
(d) certification of national
(d) certification of national
(d) certification
assessment
(d)
[certification
/
Term "certification /
bodies set up in third
bodies set up in third
of national bodies set up in
assessment] of national
assessment" depends on
countries pursuant to Article countries
, in particular
third countries pursuant to
bodies set up in third
other articles.
20(3);
candidate countries,
Article 20(3);
countries
, in particular
pursuant to Article 20(3);
candidate countries,
Informal COM suggestion:
Y
441
pursuant to Article 20(3);
Y
(d) certification of national
Linked to other provisions
bodies set up in third
countries
, in particular
Text Origin: EP Mandate
candidate countries,
pursuant to Article 20(3);
Article 37(1), point (e)
(e) other services falling
(e) other
customised
(e) other services falling
(e) other
customised
Informal COM suggestion:
within its mandate and
services falling within its
within its mandate and
services
and training falling
rendered at the request of a
mandate and rendered at the
rendered at the request of a
within its mandate and
(e) other
customised services
participating country which
request of a participating
participating country which
rendered at the request of a
falling within its mandate
Y
442
Y
require the investment of
country which require the
require the investment of
participating country which
rendered at the request of a
resources in the support of
investment of
additional
resources in the support of
require the investment of
participating country which
national activities.
resources in the support of
national activities.
additional resources in the
require the investment of
national activities.
support of national activities.
additional resources in the
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Text Origin: EP Mandate
support of national activities.
Article 37(2)
2. At the proposal of the
2. At the proposal of the
2. At the proposal of the
2. At the proposal of the
Informal COM suggestion:
Executive Director, the
Executive Director, the
Executive Director, the
Executive Director, the
Management Board of the
Management Board of the
Management Board of the
Management Board of the
2. At the proposal of the
Agency shall set the amount
Agency shall set the amount
Agency shall set the amount
Agency shall set the amount
Executive Director
and after
of the fees and the way in
of the fees and the way in
of the fees and the way in
of the fees and the way in
having consulted the
which they are paid.
which they are paid
in a
which they are paid
in a
which they are paid
in a
Commission, the
transparent manner and
transparent manner.
transparent manner and
Management Board of the
Y
443
after having consulted the
after having consulted the
Agency shall set the amount
Y
Commission. Those fees
Commission. Those fees
of
method for calculating
shall cover only the human
shall cover only the costs
the fees and the way in
and financial costs
associated with the
which they are paid
in a
associated with the
provision of the services set
transparent manner.
provision of the services set
out in paragraph 1.
out in paragraph 1.
Text Origin: EP Mandate
Article 37(3)
3. Fees shall be
3. Fees shall be
3. Fees shall be
3. Fees shall be
Informal COM suggestion:
proportionate to the costs of
proportionate to the costs of
proportionate to the costs of
proportionate to the costs of
the relevant services as
the relevant services as
the relevant services as
the relevant services as
3. Fees shall be
provided in a cost-effective
provided in a cost-effective
provided in a cost-effective
provided in a cost-effective
proportionate to the costs of
way and shall be sufficient
way and shall be sufficient
way and shall be sufficient
way and shall be sufficient
the relevant services as
to cover those costs. Fees
to cover those costs. Fees
to cover those costs. Fees
to cover those costs. Fees
provided in a cost-effective
shall be set at such a level as shall be set at such a level as shall be set at such a level as shall be set at such a level as way and shall be sufficient
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444
to ensure that they are non-
to ensure that they are non-
to ensure that they are non-
to ensure that they are non-
to cover those costs. Fees
G
discriminatory and that they
discriminatory and that they
discriminatory and that they
discriminatory and that they
shall be set at such a level as
avoid placing an undue
avoid placing an undue
avoid placing an undue
avoid placing an undue
to ensure that they are non-
financial or administrative
financial or administrative
financial or administrative
financial or administrative
discriminatory and that they
burden on stakeholders.
burden on stakeholders.
burden on stakeholders.
burden on stakeholders.
avoid placing an undue
financial or administrative
Text Origin: Commission
burden on stakeholders.
Proposal
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Article 37(4)
4. Fees should be set at a
4. Fees should be set at a
4. Fees should be set at a
4. Fees should be set at a
Informal COM suggestion:
level such as to avoid a
level such as to avoid a
level such as to avoid a
level such as to avoid a
deficit or a significant
deficit or a significant
deficit or a significant
deficit or a significant
4. Fees should be set at a
accumulation of surplus in
accumulation of surplus in
accumulation of surplus in
accumulation of surplus in
level such as to avoid a
the budget. Should a
the budget. Should a
the budget. Should a
the budget. Should a
deficit or a significant
significant positive balance
significant positive balance
significant positive balance
significant positive balance
accumulation of surplus in
in the budget, resulting from in the budget, resulting from in the budget, resulting from in the budget, resulting from the budget. Should a
the provision of the services
the provision of the services
the provision of the services
the provision of the services
significant positive balance
covered by fees, become
covered by fees, become
covered by fees, become
covered by fees, become
in the budget, resulting from
recurrent, a revision of the
recurrent, a revision of the
recurrent, a revision of the
recurrent, a revision of the
the provision of the services
level of the fees, or of the
level of the fees, or of the
level of the fees, or of the
level of the fees, or of the
covered by fees, become
Y
445
Union contribution, shall
Union contribution, shall
Union contribution, shall
Union contribution, shall
recurrent, a revision of the
Y
become mandatory. In case a become mandatory. In case a become mandatory. In case a become mandatory. In case a level of the fees, or of the
significant negative balance
significant negative balance
significant negative balance
significant negative balance
Union contribution, shall
results from the provision of results from the provision of results from the provision of results from the provision of become mandatory. In case a
the services covered by fees, the services covered by fees, the services covered by fees, the services covered by fees, significant negative balance
a revision of the level of the
a revision of the level of the
a revision of the level of the
a revision of the level of the
results from the provision of
fees shall become
fees shall
become
fees shall become
fees shall
become
the services covered by fees,
mandatory.
mandatorybe revised.
mandatory
may be applied.
mandatorybe revised.
a revision of the
method for
calculating the fees shall be
Text Origin: EP Mandate
revised level of the fees shall
become mandatory.
Article 37(4), point (a)
(a) An annual external
Informal COM suggestion:
audit shall be undertaken
with regard to the fees
5. Where applicable, the
collected by the Agency.
Agency shall include a
The Agency shall transmit
report on the fees levied and
Y
445a
the results of such audits to
their impact on the
Y
the European Parliament
Agency’s budget as part of
without delay.
the procedure for the
presentation of accounts
laid down Article 41 of this
Regulation.
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Article 38
Article 38
Article 38
Article 38
Article 38
Establishment of the budget
Establishment of the budget
Establishment of the budget
Establishment of the budget
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446
G
Text Origin: Commission
Proposal
Article 38(1)
1. Each year, the Executive
1. Each year, the Executive
1. Each year, the Executive
1. Each year, the Executive
Director shall draw up a
Director shall draw up a
Director shall draw up a
Director shall draw up a
draft statement of estimates
draft statement of estimates
draft statement of estimates
draft statement of estimates
of the Agency's revenue and of the Agency's revenue and of the Agency's revenue and of the Agency's revenue and
expenditure for the
expenditure for the
expenditure for the
expenditure for the
following financial year,
following financial year,
following financial year,
following financial year,
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447
G
including the establishment
including the establishment
including the establishment
including the establishment
plan, and send it to the
plan, and send it to the
plan, and send it to the
plan, and send it to the
Management Board.
Management Board.
Management Board.
Management Board.
Text Origin: Commission
Proposal
Article 38(2)
2. The Management Board
2. The Management Board
2. The Management Board
2. The Management Board
shall, based on that draft,
shall, based on that draft,
shall, based on that draft,
shall, based on that draft,
adopt a provisional draft
adopt a provisional draft
adopt a provisional draft
adopt a provisional draft
estimate of the Agency's
estimate of the Agency's
estimate of the Agency's
estimate of the Agency's
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448
revenue and expenditure for
revenue and expenditure for
revenue and expenditure for
revenue and expenditure for
G
the following financial year.
the following financial year.
the following financial year.
the following financial year.
Text Origin: Commission
Proposal
Article 38(3)
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3. The provisional draft
3. The provisional draft
3. The provisional draft
3. The provisional draft
estimate of the Agency's
estimate of the Agency's
estimate of the Agency's
estimate of the Agency's
revenue and expenditure
revenue and expenditure
revenue and expenditure
revenue and expenditure
shall be sent to the
shall be sent to the
shall be sent to the
shall be sent to the
Commission by 31 January
Commission by 31 January
Commission by 31 January
Commission by 31 January
each year. The Management
each year. The Management
each year. The Management
each year. The Management
Board shall send the final
Board shall send the final
Board shall send the final
Board shall send the final
draft estimate to the
draft estimate to the
draft estimate to the
draft estimate to the
Commission by 31 March.
Commission by 31 March.
Commission by 31 March.
Commission by 31 March.
Text Origin: Commission
Proposal
Article 38(4)
4. The Commission shall
4. The Commission shall
4. The Commission shall
4. The Commission shall
send the statement of
send the statement of
send the statement of
send the statement of
estimates to the budgetary
estimates to the budgetary
estimates to the budgetary
estimates to the budgetary
authority together with the
authority together with the
authority together with the
authority together with the
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450
draft general budget of the
draft general budget of the
draft general budget of the
draft general budget of the
G
European Union.
European Union.
European Union.
European Union.
Text Origin: Commission
Proposal
Article 38(5)
5. On the basis of the
5. On the basis of the
5. On the basis of the
5. On the basis of the
statement of estimates, the
statement of estimates, the
statement of estimates, the
statement of estimates, the
Commission shall enter in
Commission shall enter in
Commission shall enter in
Commission shall enter in
the draft general budget of
the draft general budget of
the draft general budget of
the draft general budget of
the Union the estimates it
the Union the estimates it
the Union the estimates it
the Union the estimates it
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451
considers necessary for the
considers necessary for the
considers necessary for the
considers necessary for the
G
establishment plan and the
establishment plan and the
establishment plan and the
establishment plan and the
amount of the subsidy to be
amount of the subsidy to be
amount of the subsidy to be
amount of the subsidy to be
charged to the general
charged to the general
charged to the general
charged to the general
budget, which it shall place
budget, which it shall place
budget, which it shall place
budget, which it shall place
before the budgetary
before the budgetary
before the budgetary
before the budgetary
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 87/95
authority in accordance with authority in accordance with authority in accordance with authority in accordance with
Articles 313 and 314 TFEU. Articles 313 and 314 TFEU. Articles 313 and 314 TFEU. Articles 313 and 314 TFEU.
Text Origin: Commission
Proposal
Article 38(6)
6. The budgetary authority
6. The budgetary authority
6. The budgetary authority
6. The budgetary authority
shall authorise the
shall authorise the
shall authorise the
shall authorise the
appropriations for the
appropriations for the
appropriations for the
appropriations for the
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452
contribution to the Agency.
contribution to the Agency.
contribution to the Agency.
contribution to the Agency.
G
Text Origin: Commission
Proposal
Article 38(7)
7. The budgetary authority
7. The budgetary authority
7. The budgetary authority
7. The budgetary authority
shall adopt the Agency's
shall adopt the Agency's
shall adopt the Agency's
shall adopt the Agency's
establishment plan.
establishment plan.
establishment plan.
establishment plan.
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453
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Text Origin: Commission
Proposal
Article 38(8)
8. The Agency's budget
8. The Agency's budget
8. The Agency's budget
8. The Agency's budget
shall be adopted by the
shall be adopted by the
shall be adopted by the
shall be adopted by the
Management Board by a
Management Board by a
Management Board by a
Management Board by a
majority of two-thirds of
majority of two-thirds of
majority of two-thirds of
majority of two-thirds of
members entitled to vote. It
members entitled to vote. It
members entitled to vote. It
members entitled to vote. It
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454
shall become final following shall become final following shall become final following shall become final following
G
final adoption of the general
final adoption of the general
final adoption of the general
final adoption of the general
budget of the European
budget of the European
budget of the European
budget of the European
Union. Where necessary, it
Union. Where necessary, it
Union. Where necessary, it
Union. Where necessary, it
shall be adjusted
shall be adjusted
shall be adjusted
shall be adjusted
accordingly.
accordingly.
accordingly.
accordingly.
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Text Origin: Commission
Proposal
Article 38(9)
9. For any building project
9. For any building project
9. For any building project
9. For any building project
likely to have significant
likely to have significant
likely to have significant
likely to have significant
implications for the budget
implications for the budget
implications for the budget
implications for the budget
of the Agency, the
of the Agency, the
of the Agency, the
of the Agency, the
provisions of Delegated
provisions of
Commission
provisions of Delegated
provisions of
Commission
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455
Regulation (EU) 2019/7151
Delegated Regulation (EU)
Regulation (EU) 2019/7151
Delegated Regulation (EU)
G
apply.
2019/7151 apply.
apply.
2019/7151 apply.
_________
_________
_________
_________
1. OJ L 122, 10.5.2019, p. 1.
1. OJ L 122, 10.5.2019, p. 1.
1. OJ L 122, 10.5.2019, p. 1.
1. OJ L 122, 10.5.2019, p. 1.
Text Origin: EP Mandate
Article 39
Article 39
Article 39
Article 39
Article 39
Implementation of the
Implementation of the
Implementation of the
Implementation of the
budget
budget
budget
budget
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456
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Text Origin: Commission
Proposal
Article 39(1)
1. The Executive Director
1. The Executive Director
1. The Executive Director
1. The Executive Director
shall implement the
shall implement the
shall implement the
shall implement the
Agency's budget.
Agency's budget.
Agency's budget.
Agency's budget.
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457
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Text Origin: Commission
Proposal
Article 39(2)
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 89/95
2. Each year the Executive
2. Each year the Executive
2. Each year the Executive
2. Each year the Executive
Director shall send to the
Director shall send to the
Director shall send to the
Director shall send to the
budgetary authority all
budgetary authority all
budgetary authority all
budgetary authority all
information relevant for the
information relevant for the
information relevant for the
information relevant for the
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evaluation procedures set out evaluation procedures set out evaluation procedures set out evaluation procedures set out
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in Article 51.
in Article 51.
in Article 51.
in Article 51.
Text Origin: Commission
Proposal
Article 40
Article 40
Article 40
Article 40
Article 40
Presentation of accounts and Presentation of accounts and Presentation of accounts and Presentation of accounts and
discharge
discharge
discharge
discharge
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Text Origin: Commission
Proposal
Article 40(1)
1. By 1 March of the
1. By 1 March of the
1. By 1 March of the
1. By 1 March of the
following financial year, the
following financial year, the
following financial year, the
following financial year, the
Agency's accounting officer
Agency's accounting officer
Agency's accounting officer
Agency's accounting officer
shall send the provisional
shall send the provisional
shall send the provisional
shall send the provisional
accounts to the
accounts to the
accounts to the
accounts to the
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Commission's accounting
Commission's accounting
Commission's accounting
Commission's accounting
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officer and to the Court of
officer and to the Court of
officer and to the Court of
officer and to the Court of
Auditors.
Auditors.
Auditors.
Auditors.
Text Origin: Commission
Proposal
Article 40(1a)
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1a. By 31 March of the
1a. By 31 March of the
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following financial year,
following financial year, the
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 90/95
the Commission's
Commission's accounting
accounting officer shall
officer shall send the
send the Agency's
Agency's provisional
provisional accounts,
accounts, consolidated with
consolidated with the
the Commission's accounts,
Commission's accounts, to
to the Court of Auditors.
the Court of Auditors.
Text Origin: Council
Mandate
Article 40(2)
2. By 31 March of the
2. By 31 March of the
2. By 31 March of the
2. By 31 March of the
following financial year, the
following financial year, the
following financial year, the
following financial year, the
Agency shall send the report Agency shall send the report Agency shall send the report Agency shall send the report
on the budgetary and
on the budgetary and
on the budgetary and
on the budgetary and
financial management to the financial management to the financial management to the financial management to the
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European Parliament, the
European Parliament, the
European Parliament, the
European Parliament, the
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Council and the Court of
Council and the Court of
Council and the Court of
Council and the Court of
Auditors.
Auditors.
Auditors.
Auditors.
Text Origin: Commission
Proposal
Article 40(3)
3. By 31 March of the
3. By 31 March of the
following financial year, the
following financial year, the
deleted
deleted
Commission's accounting
Commission's accounting
officer shall send the
officer shall send the
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Agency's provisional
Agency's provisional
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accounts, consolidated with
accounts, consolidated with
the Commission's accounts,
the Commission's accounts,
to the Court of Auditors.
to the Court of Auditors.
Article 40(4)
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Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 91/95
4. On receipt of the Court of 4. On receipt of the Court of 4. On receipt of the Court of 4. On receipt of the Court of
Auditors' observations on the Auditors' observations on the Auditors' observations on the Auditors' observations on the
Agency's provisional
Agency's provisional
Agency's provisional
Agency's provisional
accounts pursuant to Article
accounts pursuant to Article
accounts pursuant to Article
accounts pursuant to Article
246 of the Financial
246 of the Financial
246 of the Financial
246 of the Financial
Regulation1, the Executive
Regulation1, the Executive
Regulation1, the Executive
Regulation1, the Executive
Director shall draw up the
Director shall draw up the
Director shall draw up the
Director shall draw up the
Agency's final accounts
Agency's final accounts
Agency's final accounts
Agency's final accounts
under her/his own
under her/his own
under her/his own
under her/his own
responsibility and submit
responsibility and submit
responsibility and submit
responsibility and submit
them to the Management
them to the Management
them to the Management
them to the Management
Board for an opinion.
Board for an opinion.
Board for an opinion.
Board for an opinion.
_________
_________
_________
_________
1. Regulation (EU, Euratom)
1. Regulation (EU, Euratom)
1. Regulation (EU, Euratom)
1. Regulation (EU, Euratom)
2018/1046 of the European
2018/1046 of the European
2018/1046 of the European
2018/1046 of the European
Parliament and of the Council of
Parliament and of the Council of
Parliament and of the Council of
Parliament and of the Council of
18 July 2018 on the financial rules
18 July 2018 on the financial rules
18 July 2018 on the financial rules
18 July 2018 on the financial rules
applicable to the general budget of
applicable to the general budget of
applicable to the general budget of
applicable to the general budget of
the Union, amending Regulations
the Union, amending Regulations
the Union, amending Regulations
the Union, amending Regulations
(EU) No 1296/2013, (EU) No
(EU) No 1296/2013, (EU) No
(EU) No 1296/2013, (EU) No
(EU) No 1296/2013, (EU) No
1301/2013, (EU) No 1303/2013,
1301/2013, (EU) No 1303/2013,
1301/2013, (EU) No 1303/2013,
1301/2013, (EU) No 1303/2013,
(EU) No 1304/2013, (EU) No
(EU) No 1304/2013, (EU) No
(EU) No 1304/2013, (EU) No
(EU) No 1304/2013, (EU) No
1309/2013, (EU) No 1316/2013,
1309/2013, (EU) No 1316/2013,
1309/2013, (EU) No 1316/2013,
1309/2013, (EU) No 1316/2013,
(EU) No 223/2014, (EU) No
(EU) No 223/2014, (EU) No
(EU) No 223/2014, (EU) No
(EU) No 223/2014, (EU) No
283/2014, and Decision No
283/2014, and Decision No
283/2014, and Decision No
283/2014, and Decision No
541/2014/EU and repealing
541/2014/EU and repealing
541/2014/EU and repealing
541/2014/EU and repealing
Regulation (EU, Euratom) No
Regulation (EU, Euratom) No
Regulation (EU, Euratom) No
Regulation (EU, Euratom) No
966/2012 (OJ L 193, 30.7.2018, p.
966/2012 (OJ L 193, 30.7.2018, p.
966/2012 (OJ L 193, 30.7.2018, p.
966/2012 (OJ L 193, 30.7.2018, p.
1).
1).
1).
1).
Text Origin: Commission
Proposal
Article 40(5)
5. The Management Board
5. The Management Board
5. The Management Board
5. The Management Board
shall deliver an opinion on
shall deliver an opinion on
shall deliver an opinion on
shall deliver an opinion on
the Agency's final accounts.
the Agency's final accounts.
the Agency's final accounts.
the Agency's final accounts.
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Text Origin: Commission
Proposal
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 92/95
Article 40(6)
6. The accounting officer
6. The accounting officer
6. The accounting officer
6. The accounting officer
shall, by 1 July following
shall, by 1 July following
shall, by 1 July following
shall, by 1 July following
each financial year, send the each financial year, send the each financial year, send the each financial year, send the
final accounts to the
final accounts to the
final accounts to the
final accounts to the
European Parliament, the
European Parliament, the
European Parliament, the
European Parliament, the
Council, the Commission
Council, the Commission
Council, the Commission
Council, the Commission
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and the Court of Auditors,
and the Court of Auditors,
and the Court of Auditors,
and the Court of Auditors,
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together with the
together with the
together with the
together with the
Management Board's
Management Board's
Management Board's
Management Board's
opinion.
opinion.
opinion.
opinion.
Text Origin: Commission
Proposal
Article 40(7)
7. The final accounts shall
7. The final accounts shall
7. The final accounts shall
7. The final accounts shall
be published in the Official
be published in the Official
be published in the Official
be published in the Official
Journal of the European
Journal of the European
Journal of the European
Journal of the European
Union by 15 November of
Union by 15 November of
Union by 15 November of
Union by 15 November of
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the following year.
the following year.
the following year.
the following year.
Text Origin: Commission
Proposal
Article 40(8)
8. The Executive Director
8. The Executive Director
8. The Executive Director
8. The Executive Director
shall send the Court of
shall send the Court of
shall send the Court of
shall send the Court of
Auditors a reply to its
Auditors a reply to its
Auditors a reply to its
Auditors a reply to its
observations by 30
observations by 30
observations by 30
observations by 30
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September. The Executive
September. The Executive
September. The Executive
September. The Executive
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Director shall also send this
Director shall also send this
Director shall also send this
Director shall also send this
reply to the Management
reply to the Management
reply to the Management
reply to the Management
Board.
Board.
Board.
Board.
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 93/95
Text Origin: Commission
Proposal
Article 40(9)
9. The Executive Director
9. The Executive Director
9. The Executive Director
9. The Executive Director
shall submit to the European shall submit to the European shall submit to the European shall submit to the European
Parliament, at the latter's
Parliament, at the latter's
Parliament, at the latter's
Parliament, at the latter's
request, any information
request, any information
request, any information
request, any information
required for the smooth
required for the smooth
required for the smooth
required for the smooth
application of the discharge
application of the discharge
application of the discharge
application of the discharge
procedure for the financial
procedure for the financial
procedure for the financial
procedure for the financial
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year in question, in
year in question, in
year in question, in
year in question, in
accordance with Article
accordance with Article
accordance with Article
accordance with Article
261(3) of the Financial
261(3) of the Financial
261(3) of the Financial
261(3) of the Financial
Regulation.
Regulation.
Regulation.
Regulation.
Text Origin: Commission
Proposal
Article 40(10)
10. On a recommendation
10. On a recommendation
10. On a recommendation
10. On a recommendation
from the Council acting by a from the Council acting by a from the Council acting by a from the Council acting by a
qualified majority, the
qualified majority, the
qualified majority, the
qualified majority, the
European Parliament shall,
European Parliament shall,
European Parliament shall,
European Parliament shall,
before 15 May of year N +
before 15 May of year N +
before 15 May of year N +
before 15 May of year N +
2, give a discharge to the
2, give a discharge to the
2, give a discharge to the
2, give a discharge to the
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Executive Director in respect Executive Director in respect Executive Director in respect Executive Director in respect
of the implementation of the of the implementation of the of the implementation of the of the implementation of the
budget for year N.
budget for year N.
budget for year N.
budget for year N.
Text Origin: Commission
Proposal
Article 41
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Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 94/95
Article 41
Article 41
Article 41
Article 41
Financial rules
Financial rules
Financial rules
Financial rules
Text Origin: Commission
Proposal
Article 41, first paragraph
The financial rules
The financial rules
The financial rules
The financial rules
applicable to the Agency
applicable to the Agency
applicable to the Agency
applicable to the Agency
shall be adopted by the
shall be adopted by the
shall be adopted by the
shall be adopted by the
Management Board after
Management Board after
Management Board after
Management Board after
consulting the Commission.
consulting the Commission.
consulting the Commission.
consulting the Commission.
They shall not depart from
They shall not depart from
They shall not depart from
They shall not depart from
Delegated Regulation (EU)
Delegated Regulation (EU)
Delegated Regulation (EU)
Delegated Regulation (EU)
2019/715 unless such a
2019/715 unless such a
2019/715 unless such a
2019/715 unless such a
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departure is specifically
departure is specifically
departure is specifically
departure is specifically
required for the Agency's
required for the Agency's
required for the Agency's
required for the Agency's
operation and the
operation and the
operation and the
operation and the
Commission has given its
Commission has given its
Commission has given its
Commission has given its
prior consent.
prior consent.
prior consent.
prior consent.
Text Origin: Commission
Proposal
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Union Drugs Agency 2022/0009(COD) 02-02-2023 at 09h16 95/95
Document Outline
