Council of the
European Union
Brussels, 20 February 2019
(OR. en)
6638/19
Interinstitutional File:
2018/0161(COD)
PI 38
CODEC 490
COMPET 162
PHARM 10
IA 73
NOTE
From:
General Secretariat of the Council
To:
Permanent Representatives Committee
No. prev. doc.:
6383/19
No. Cion doc.:
9485/18 + ADD1 + ADD2 + ADD3 + ADD 4
Subject:
Proposal for a Regulation amending Regulation (EC) No 469/2009
concerning the supplementary protection certificate for medicinal products
- Outcome of proceedings
Delegations will find attached the compromise text on the above mentioned proposal as approved
by the Permanent Representatives Committee on 20 February 2019.
______________________
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Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for
medicinal products
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114
thereof,
Having regard to the proposal from the European Commission
After transmission of the draft legislative act to the national parliaments
Having regard to the opinion of the European Economic and Social Committee1,
Acting in accordance with the ordinary legislative procedure,
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Whereas:
(1) Regulation (EC) No 469/2009 of the European Parliament and of the Council1 provides that
any product protected by a patent in the territory of a Member State and subject, prior to being
placed on the market as a medicinal product, to an administrative authorisation procedure as
laid down in Directive 2001/83/EC of the European Parliament and of the Council2or
Directive 2001/82/EC of the European Parliament and of the Council3, may be the subject of a
supplementary protection certificate under the terms and conditions provided for in
Regulation (EC) No 469/2009.
(2) By providing for a period of supplementary protection of up to five years, Regulation (EC)
No 469/2009 seeks to promote, within the Union, the research and innovation that is
necessary to develop medicinal products, and to contribute to preventing the relocation of
pharmaceutical research outside the Union to countries that may offer greater protection.
(3) Since the adoption in 1992 of the predecessor to Regulation (EC) No 469/2009, markets have
evolved significantly and there has been huge growth in the manufacture of generics and
especially of biosimilars, and their active ingredients, in particular in countries outside the EU
(‘third countries’) where protection does not exist or has expired.
1 Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009
concerning the supplementary protection certificate for medicinal products (OJ L 152, 16.6.2009,
p. 1).
2 Directive
2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p.67).
3 Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the
Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).
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(4) The absence of any exception in Regulation (EC) No 469/2009 to the protection conferred by
a supplementary protection certificate has had the unintended consequence of preventing
makers of generics and biosimilars established in the Union from making in the Union, even
for the purpose of exporting to third country markets in which protection does not exist or has
expired. Likewise, they are prevented from making for the purpose of storing for a limited
period before the expiry of the certificate. This makes it more difficult for those makers to
enter the Union market immediately after expiry of the certificate, given that they are not in a
position to build up production capacity for export and for the purpose of entering the market
of a Member State until the protection provided by the certificate has expired, by contrast
with makers located in third countries where protection does not exist or has expired.
(5) This puts makers of generics and biosimilars established in the Union at a significant
competitive disadvantage compared with makers based in third countries that offer less or no
protection. The Union should strike a balance between restoring a level playing field between
those makers and ensuring that the essence of the exclusive rights of certificate holders is
guaranteed in relation to the Union market.
(6) Without any intervention, the viability of makers of generics and biosimilars established in
the Union could be under threat, with consequences for the Union’s pharmaceutical industrial
base as a whole. This may affect the fully effective functioning of the internal market, through
the loss of potential new business opportunities for generics and biosimilars, possibly
diminishing related investments within the Union, thereby possibly hampering job creation.
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(6a) The timely entry of generics and biosimilars onto the Union market is important, notably to
increase competition, to reduce prices and to ensure both the sustainability of national
healthcare systems and better access to affordable medicines by patients in the EU. The
importance of such timely entry has been underlined by the Council in its conclusions of 17
June 2016 on strengthening the balance in the pharmaceutical systems in the Union and its
Member States. Regulation (EC) No 469/2009 should therefore be amended so as to allow the
production of generics and biosimilars for export and storage, while recalling that intellectual
property rights remain one of the cornerstones of innovation, competitiveness and growth in
the internal market.
(7) The aim of this Regulation is to promote the competitiveness of the Union, enhancing growth
and job creation in the internal market and contributing to a wider supply of products under
uniform conditions, by allowing makers of generics and biosimilars established in the Union
to make in the Union medicinal products or products for the purpose of export to third country
markets where protection does not exist or has expired, thereby also helping these makers to
compete effectively in those third country markets. The Regulation should also allow these
makers to make and store medicinal products or products in a Member State for a defined
period pending the expiry of the certificate for the purpose of entering the market of any
Member State upon expiry of the corresponding certificate (EU ‘Day-one’ entry), thereby
helping these makers to compete effectively in the Union immediately after protection has
expired. It should also complement the efforts of the Union’s trade policy to ensure open
markets for Union-based makers of medicinal products or products. Over time, the Regulation
should benefit the entire pharmaceutical sector in the Union, by allowing all players,
including newcomers, to reap the benefits of the new opportunities opening up in the fast-
changing global pharmaceutical market. Furthermore, the common interest in the Union
would be promoted as, through the reinforcement of Union-based supply chains for
medicines, and by allowing storing in view of entry onto the Union market upon expiry of the
certificate, medicines would become more accessible to patients in the Union after the expiry
of the certificate.
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(8) In these specific and limited circumstances, and in order to create a level playing field
between Union-based makers and third country makers, it is appropriate to restrict the
protection conferred by a certificate so as to allow making for the exclusive purpose of export
to third countries and any related acts in the Union strictly necessary for making or for the
actual export itself, where such acts would otherwise require the consent of a certificate
holder (‘related acts’). For instance, such acts could include the possession, supply, offering to
supply, import, using or synthesis of an active ingredient for the purpose of making a
medicinal product containing that product, or temporary storage of the product or advertising
for the exclusive purpose of export to third country destinations.The exception should also
apply to related acts performed by third parties who are in a contractual relationship with the
maker.
(9) This exception should apply to a product, or a medicinal product containing that product,
protected by a certificate. It should cover the making of the product protected by a certificate
in the territory of a Member State and the making of the medicinal product containing that
product.
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(10) The exception should not cover placing the product or medicinal product containing that
product, which is made for the purpose of export to third countries or storing in view of EU
Day-one entry, on the market in the Member State where a certificate is in force, either
directly, or indirectly after export, nor should it cover re-importation of the product to the
market of a Member State in which a certificate is in force. Moreover, it should not cover any
act or activity for the purpose of import of products or medicinal products into the Union
merely for the purposes of repackaging and re-exporting. The exception should not cover any
storage of the product or medicinal product containing that product for any purposes other
than those set out in this Regulation.
(11) By limiting the scope of the exception to the making for the purpose of export outside the
Union or to the making for the purpose of storing, and to acts strictly necessary for such
making or for the actual export or the actual storing itself, the exception introduced by this
Regulation should not conflict with the normal exploitation of the product or medicinal
product containing that product in the Member State where the certificate is in force, namely
with the core exclusive right of the certificate holder to make that product for the purpose of
placing it on the Union market during the term of the certificate. In addition, the exception
should not unreasonably prejudice the legitimate interests of the certificate holder, whilst
taking account of the legitimate interests of third parties.
(12) Effective and proportionate safeguards should accompany the exception in order to increase
transparency, to help the holder of a certificate to enforce its protection in the Union, to check
compliance with the conditions set out in this Regulation and to reduce the risk of illicit
diversion onto the Union market during the term of the certificate.
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(13) To this end, this Regulation should impose an information obligation on the maker, namely
the person established in the Union, on whose behalf the making of a product or medicinal
product containing that product for the purpose of export or storing is done (this includes the
possibility of the person itself directly doing the making). Namely, the maker should provide
certain information to the authority which granted the certificate in the Member State where
the making is to take place. A common notification form should be provided for this purpose.
The information should be provided before the making starts for the first time in that Member
State, or before any related act prior to that making, whichever is the earlier. It should be
updated as and when appropriate. The making and related acts, including those performed in
Member States other than the one of making in cases where the product is protected by a
certificate in those other Member States too, should only fall within the scope of the exception
where the maker has sent this notification to the competent industrial property authority (or
other designated authority) of the Member State of making and has informed the holder of the
certificate granted in that Member State. Should making take place in more than one Member
State, a notification should be required in each of these Member States. In the interests of
transparency, the authority should be required to publish, as soon as possible, the information
it receives, together with the date of notification of that information. Member States should be
allowed to require that notifications, and updates to notifications, be subject to the payment of
a once-off fee. This fee should be set at a level which does not exceed the administrative cost
of processing notifications and updates.
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(13a) The maker should also inform the certificate holder, through appropriate and documented
means, of the intention to make a product or medicinal product containing that product
pursuant to the exception, by providing the certificate holder with the same information as
notified to the authority. That information is limited to what is necessary and appropriate for
the certificate holder to assess whether the rights conferred by the certificate are being
respected, and does not include confidential or commercially sensitive information. The
information to the certificate holder may be provided by making use of the same common
notification form, and the information provided should be updated as and when appropriate.
(13b) Regarding related acts prior to the making, if any, the notification should list the name of the
Member State where the first related act, which would otherwise require the consent of a
certificate holder, is to take place, as this information is relevant to the timing of the
notification.
(13c) If the local marketing authorisation, or equivalent, in a specific third country, for a given
medicinal product, is published after the notification is made, the notification should be
promptly updated to include the reference number of that marketing authorisation, as soon as
it is publicly available. If the reference number of the granted authorisation is pending
publication, the maker should be required to provide, in the notification, that reference
number as soon as it is publicly available.
(13d) For reasons of proportionality, failure to comply with these requirements regarding a third
country would only affect exports to that country, and exports to such third country would
thus not benefit from the exception. It should be the responsibility of the maker established in
the Union to verify that protection does not exist or has expired in a country of export, subject
to any limitations or exemptions in that country. A notification to an authority and the
corresponding information to the certificate holder may be provided already during the period
between the entry into force of the Regulation and the date on which the exception itself
becomes applicable.
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(14) In addition, this Regulation should impose certain due diligence requirements on the maker as
a condition for the exception to operate. The maker should be required to inform persons
within its supply chain in the Union, including the exporter and the person doing the storing,
through appropriate and documented means, in particular contractual means, that the product
or medicinal product containing that product is covered by the exception introduced by this
Regulation and is intended for the purpose of export or storing, as applicable. A maker who
failed to comply with these due diligence requirements would not benefit from the exception,
nor would any third party performing a related act in the same or a different Member State
where a certificate conferring protection for the product was in force, and the holder of the
relevant certificate would therefore be entitled to enforce its rights under the certificate, while
paying due regard to the general obligation, set out in Directive 2004/48/EC of the European
Parliament and of the Council4, not to engage in abusive litigation.
(15) Furthermore, in respect of products to be exported, this Regulation should impose labelling
requirements on the maker, in order to facilitate, by means of a logo, identification of the
product or medicinal product containing that product as being exclusively intended for the
purpose of export to third countries. The making for the purposes of export and related acts
should only fall outside the protection conferred by a certificate if the product or medicinal
product containing that product is labelled in this manner. This labelling obligation would be
without prejudice to labelling requirements of third countries.
(16) Any act not covered by the exception introduced by this Regulation will remain within the
scope of the protection conferred by a certificate. Any diversion onto the Union market,
during the term of the certificate, of any product or medicinal product containing that product
made within the terms of the exception, will remain prohibited.
4 Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the
enforcement of intellectual property rights (OJ L157, 30.4.2004, p. 45).
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(17) This Regulation is without prejudice to the respect of other intellectual property rights that
may protect other aspects of a medicinal product. This Regulation does not affect the
application of Union measures that aim to prevent infringements and facilitate enforcement of
intellectual property rights, including Directive 2004/48/EC5 and Regulation (EU) No
608/2013 of the European Parliament and of the Council5. Furthermore, this Regulation does
not affect the rules on the unique identifier provided for by Directive 2001/83/EC of the
European Parliament and of the Council as amended by Directive 2011/62/EU and as
provided for by Commission Delegated Regulation (EU) 2016/1616. The maker ensures that
the medicinal product made pursuant to point (a)(i) of paragraph 2 does not bear an active
unique identifier within the meaning of Directive 2011/62/EU. However, the requirement to
affix an active unique identifier applies to medicinal products to be placed on the market of a
Member State upon expiry of the corresponding certificate.
(18) This Regulation does not affect the application of Directives 2001/83/EC and 2001/82/EC, in
particular the requirements related to the manufacturing authorisation of medicinal products
manufactured for export. This includes compliance with the principles and guidelines of good
manufacturing practices for medicinal products and the use of active substances that have
been manufactured in accordance with good manufacturing practices for active substances
and distributed in accordance with good distribution practices for active substances.
5 Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013
concerning customs enforcement of intellectual property rights (OJ L 181, 29.6.2013, p. 15).
6 Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive
2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the
safety features appearing on the packaging of medicinal products for human use (OJ L 32,
9.2.2016, p. 1).
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(19) To safeguard the rights of certificate holders, the exception should not apply to a certificate
that has already taken effect at the date of entry into force of the Regulation. In order to
ensure that the rights of certificate holders are not excessively restricted, the exception
provided for in this Regulation should apply to certificates that are applied for on or after the
day of the entry into force of this Regulation. At the same time, in order to safeguard the aim
of this Regulation, and since a certificate takes effect at the end of the lawful term of the basic
patent, which can be a relatively long time after the date of filing of the application for the
certificate, it is justified to bring within the scope of the Regulation, over a certain period of
time, a certificate that was applied for before the entry into force of this Regulation, but has
not yet taken effect before that entry into force, and irrespective of whether or not that
certificate has been granted before the entry into force of the Regulation. Therefore, the
exception should apply, as from 1 July 2022, to a certificate that takes effect as from that
entry into force. This ‘certain period of time’ for each individual certificate that takes effect
after that entry into force should ensure that the exception is applied, on a progressive basis,
to such a certificate, depending on its date of taking effect and its duration. Such application
of the exception would allow the holder of a granted certificate that has not yet taken effect by
the date of the entry into force of the Regulation a reasonable period of transition to adapt to
the changed legal context, while at the same time ensuring that makers of generics and
biosimilars can benefit effectively, without excessive delay, from the exception.
(19a) An applicant for a certificate might be expected to file an application at around the same date
in each Member State of filing. However due to differences in national procedures for
examination of applications, the date of grant might vary significantly from one Member State
to another, thereby creating disparities in the legal situation of the applicant in the different
Member States where the certificate is applied for. Introducing the exception on the basis of
the date of filing of the application for a certificate would therefore promote uniformity and
limit this risk of disparities.
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(20) The Commission should carry out a regular evaluation of this Regulation. Pursuant to
paragraph 22 of the Interinstitutional Agreement between the European Parliament, the
Council of the European Union and the European Commission on Better Law-Making of 13
April 20167, that evaluation should be based on the five criteria of effectiveness, efficiency,
relevance, coherence and added value and should provide the basis for impact assessments of
possible further measures. The evaluation should take into account on the one hand, exports to
outside the Union, and on the other, the effects of storing on swifter entry of generic and
especially biosimilar medicines onto markets in the Union as soon as possible after a
certificate lapses. Such regular evaluation should also address the effects of this Regulation on
making within the Union by generic and biosimilar makers based in the Union. In this
context, it would be important to ascertain whether making that was previously taking place
outside of the Union would be moved to within its territory. In particular, this evaluation
should review the effectiveness of the exception in the light of the aim to restore a global level
playing field for generic and biosimilar firms in the Union . It should also study the impact of
the exception on research and production of innovative medicines in the Union by holders of
certificates and consider the balance between the different interests at stake, notably public
health, public expenditure and, in this context, access to medicines within the Union. It should
also study whether the period foreseen for making for the purpose of storing is sufficient to
achieve the objective of EU Day-one entry, including its effects on public health.
(21) It is necessary and appropriate for the achievement of the basic objective, of providing a level
playing field for makers of generics and biosimilars with their competitors in third country
markets where protection does not exist or has expired, to lay down rules enabling the making
of the product in question during the term of the certificate, and also to provide certain
information and labelling obligations on makers using those rules
. This Regulation complies
with the principle of proportionality, and does not go beyond what is necessary in order to
achieve the objectives pursued, in accordance with Article 5(4) of the Treaty on European
Union.
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(22) This Regulation respects fundamental rights and observes the principles recognised by the
Charter of Fundamental Rights of the European Union. In particular, this Regulation seeks to
ensure full respect for the right to property in Article 17, and the right to health care under
Article 35, of the Charter. The Regulation should maintain the core rights of the certificate, by
confining the exception provided for in this Regulation to the making of a product or a
medicinal product containing that product only for the purpose of export outside the Union or
for the purpose of storing it during a limited period of time in view of entry onto the Union
market upon expiry of the protection, and to the acts strictly necessary for such making or for
the actual export or storing itself. This exception does not go beyond what is necessary and
appropriate in the light of the overall objective of this Regulation, which is to promote the
competitiveness of the Union by avoiding delocalisations and allowing Union-based makers
of generics and biosimilars to compete, on the one hand, on fast-growing, global markets
where protection does not exist or has already expired, and on the other, on the Union market
upon expiry of the certificate. Indeed, it is necessary to benefit from those positive economic
effects arising from the exception, as otherwise the Union would risk substantially weakening
its position as a hub for pharmaceutical development and manufacturing. It is therefore
appropriate to introduce that exception in order to increase the competitive position of Union-
based makers of generics and biosimilars in third countries whose markets are in any event
open to competition, whilst leaving the scope and duration of the protection granted by the
certificate in the Union untouched. The appropriateness of the measure is further ensured by
providing for appropriate safeguards regulating the use of the exception. The Regulation
should allow sufficient time for public authorities to put in place the necessary arrangements
to receive and publish notifications,
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HAVE ADOPTED THIS REGULATION
Article 1 – Amendment of Regulation (EC) No 469/2009
Regulation (EC) No 469/2009 is amended as follows:
(-1) in Article 1, the following point is added:
‘(f) ‘maker’ means the person established in the Union on whose behalf the making of a
product or a medicinal product containing that product, for the purpose of export to
third countries or for the purpose of storing, is done;’
(1) Article 5 is replaced by the following:
‘Article 5 – Effects of the certificate
1.
Subject to the provisions of Article 4, the certificate shall confer the same rights as
conferred by the basic patent and shall be subject to the same limitations and the same
obligations.
2.
By way of derogation from paragraph 1, the certificate referred to in paragraph 1 shall
not confer protection against certain acts which would otherwise require the consent of
the holder of the certificate, referred to in Article 11 (‘the certificate holder’) if the
following conditions are met:
(a) the acts comprise:
(i)
making a product, or a medicinal product containing that product, for the
purpose of export to third countries; or
(ii) any related act that is strictly necessary for that making in the Union or for
the actual export itself; or
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(iii) making, no earlier than 6 months before the expiry of the certificate, a
product, or a medicinal product containing that product, for the purpose of
storing it in the Member State of making in order to place that product, or a
medicinal product containing that product, on the market of Member States
after the expiry of the certificate;or
(iv) any related act that is strictly necessary for the making in the Union as
referred to in point (iii), or for the actual storing itself, provided that such
related act is carried out no earlier than 6 months before the expiry of the
certificate.
(b) the maker, through appropriate and documented means, notifies the authority
referred to in Article 9(1) of the Member State where that making is to take place
and informs the certificate holder of the information listed in paragraph 3 no later
than three months before the start date of making in that Member State, or no later
than three months before the first related act prior to that making that would
otherwise be prohibited by the protection conferred by a certificate, whichever is
the earlier;
(ba) if the information listed in paragraph 3 changes, the maker shall notify the
authority referred to in Article 9(1) and shall inform the certificate holder, before
these changes take effect;
(c) in the case of products made for the purpose of export to third countries, the
maker ensures that a logo, in the form set out in Annex -I, is affixed to the outer
packaging of the product or of the medicinal product containing that product,
referred to in paragraph 2(a)(i), and, where feasible, to its immediate packaging;
(d) the maker complies with the requirements of paragraph 4 and, if applicable, of
Article 12(2).
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2a. The exception referred to in paragraph 2 shall not apply to any act or activity for import
of medicinal products, or parts thereof, into the Union merely for the purpose of
repackaging and re-exporting or storing.
2b. The information provided to the certificate holder shall be used exclusively for the
purposes of verifying whether the requirements of this Regulation have been met and,
where applicable, initiating legal proceedings for non-compliance.
3.
The information for the purposes of paragraph 2(b) shall be as follows:
(a) the name and address of the maker;
(aa) an indication of whether the making is for the purpose of export, for the purpose
of storing, or for the purpose of both export and storing;
(b) the Member State where the making and if applicable, also the storing is to take
place and the Member State where the first related act, if any, prior to that making
is to take place;
(c) the number of the certificate granted in the Member State of making, and the
number of the certificate granted in the Member State of the first related act, if
any, prior to that making;
(d)
(deleted)
(e)
(deleted)
(f)
for medicinal products to be exported to third countries, the reference number of
the marketing authorisation or equivalent in each third country of export , as soon
as it is publicly available.
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3a. For the purposes of notification to the competent authority under points (b) and (ba) of
paragraph, the maker shall use the standard form contained in Annex -Ia.
3b. Failure to comply with the requirements of paragraph 3(f) in respect of a third country
shall only affect exports to that country, and such exports would thus not benefit from
the exception.
3c. The maker ensures that the medicinal product made pursuant to point (a)(i) of
paragraph 2 does not bear an active unique identifier within the meaning of Commission
Delegated Regulation (EU) 2016/161.
4.
The maker shall ensure, through appropriate and documented means, that any person in
a contractual relationship with the maker who performs acts falling within paragraph
2(a) are fully informed and aware of the following:
(a) that those acts are subject to the provisions of paragraph 2;
(b) that the placing on the market, import or re-import of the product referred to in
point (a)(i) of paragraph 2 or the placing on the market of the product referred to
in point (a)(iii) of paragraph 2 might infringe the certificate referred to in
paragraph 2 where, and as long as, that certificate applies.
5.
Paragraph 2 shall apply to certificates that are applied for on or after the entry into force
of this Regulation.
Paragraph 2, shall also apply, to certificates that have been applied for before the entry
into force of this Regulation and that take effect on or after the entry into force of this
Regulation Paragraph 2 shall only apply to such certificates from 1 July 20227.
Paragraph 2 shall not apply to certificates that enter into effect before the entry into
force of this Regulation.’;
7 Date to be replaced by the actual date of entry into force of the Regulation, plus 3 years.
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(2) in Article 11, the following paragraph is added:
4.
‘The authority referred to in Article 9(1) shall publish, as soon as possible, the
information listed in Article 5(3), together with the date of notification of that
information. It shall also publish, as soon as possible, any changes to this information
notified in accordance with Article 5(2)(ba).’;
(2a) Article 12 is replaced by the following:
‘
Article 12 – Fees
1.
Member States may require that the certificate be subject to the payment of annual fees.
2.
Member States may require that the notifications referred to in Article 5(2)(b) and (ba)
be subject to the payment of a fee.’;
[Note to translators: Paragraph 1 corresponds to the existing Article 12 of Regulation
(EC) No 469/2009]
(3) the following Article is inserted:
‘
Article 21a – Evaluation
No later than five years after the date referred to in Article 5(5), and every five years
thereafter, the Commission shall carry out an evaluation of Articles 5(2) to (4) and 11 in
order to assess whether the objectives of these provisions have been achieved, and
present a report on the main findings to the European Parliament, the Council and the
European Economic and Social Committee. In addition to evaluating the impact of the
exception of making for the purpose of export, special account shall be taken of the
effects of making for the purpose of storing with a view to ensuring EU Day-one entry,
on access to medicines and on public health expenditure, and on whether the waiver and
in particular the period foreseen in point (a)(iii) of Article 5(2) is sufficient to achieve
the objectives mentioned in Article 5 including public health.’;
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(4) the Annexes to this Regulation are inserted as Annexes -I and -Ia.
[Note: Numbering of Annexes to be checked by jurist linguists]
Article 2 – Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in
the
Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the European Parliament
For the Council
The President
The President
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ANNEX -I
Logo
This logo should appear in black colour and of such size as to be sufficiently visible.
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ANNEX -Ia
Form for notification pursuant to Article 5(2)(b) and (ba)
Tick the appropriate box
New notification
Update of an existing notification
(a) Purpose of making
Export
Storing
Export and storing
(aa) Name and address of the
…
maker
(b) Member State where making
Member State of making:
…
is to take place and Member State
where first related act (if any)
(Member State of first related act (if
…
prior to making is to take place
any))
(c) Number of certificate granted
Certificate of Member State of making
…
in the Member State of making
and number of certificate granted
in Member State of first related
(Certificate of Member State of first
…
related act (if any))
act (if any) prior to making
(d)* (deleted)
(e)* (deleted)
(f) for medicinal products to be
…
exported to third countries,
reference number of marketing
…
authorisation or equivalent in each
third country of export
…
[*Note: points (d) and (e) of Article 5(3) have been deleted; however, for ease of reference in the neogotiations, the
numbering of paragraphs, both in the form above and in Article 5, is retained, but will be adjusted before adoption of
the Regulation. In addition, the current points (a) to (f) will be re-numbered at the jurists-linguists stage (i.e. meaning
that current point (f) will become point (d)). These changes will also be carried through in Article.]
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Document Outline
