Request to RSB Secretariat regarding general pharmaceutical legislation and ambient air quality fitness check
Dear Secretariat General of the European Commission,
Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting the following documents related to the revision of the general pharmaceutical legislation and the ambient air quality directives (AAQD) Fitness Check which we believe are held by the Regulatory Scrutiny Board (RSB) Secretariat.
Revision of the general pharmaceutical legislation
1. The first draft of the general pharmaceutical legislation impact assessment report, submitted on 22 June 2023 by DG SANTE to the RSB (and issued a negative opinion).
2. The revised draft of the general pharmaceutical legislation impact assessment report, submitted on 28 Oct 2022 by DG SANTE to the RSB (and issued a positive opinion with reservations).
3. Additional information circulated in the context of this RSB review, and noted in the first RSB opinion (summarising the 19 July 2022 RSB meeting):
(a) The ‘additional information provided [by DG SANTE] in advance of the meeting’ on 19 July 2022.
(b) Additional, the ‘more technical comments […] sent directly to the author DG’ by the RSB.
4. Any documentation DG SG holds regarding the Inter-service consultation for the revised general pharmaceutical legislation.
5. Minutes of all inter-service steering group meetings which informed the revision of the general pharmaceutical legislation.
Fitness Check of the EU Ambient Air Quality Directives
1. The first draft of the Fitness Check report, discussed by the RSB on 17 July 2019 (and issued a negative opinion).
2. The revised draft of the Fitness Check report, submitted on 16 August 2019 to the RSB (and issued a positive opinion).
3. Any documentation DG SG holds regarding the Inter-service consultation for the AAQD Fitness Check
4. Minutes of all inter-service steering group meetings which informed the revision of the AAQD Fitness Check
Please do not hesitate to let me know if you require any clarification regarding the above. If any of these documents are held only by the respective DGs (and not SecGen), I would greatly appreciate if you could flag this so I can request them separately. Many thanks in advance for your help.
Your sincerely,
Dr Kathrin Lauber
University of Edinburgh, School of Social and Political Science
Chrystal Macmillan Building
15a George Square
EH8 9LD Edinburgh (UK)
Your message has been received by the Transparency Unit of the
Secretariat-General of the European Commission.
Requests for public access to documents are treated on the basis of
[1]Regulation (EC) No 1049/2001 of 30 May 2001 regarding public access to
European Parliament, Council and Commission documents.
The Secretariat-General will reply to your request within 15 working days
upon registration of your request and will duly inform you of the
registration of the request (or of any additional information to be
provided in view of its registration and/or treatment).
L’unité «Transparence» du secrétariat général de la Commission européenne
a bien reçu votre message.
Les demandes d’accès du public aux documents sont traitées sur la base du
[2]règlement (CE) n° 1049/2001 du 30 mai 2001 relatif à l’accès du public
aux documents du Parlement européen, du Conseil et de la Commission.
Le secrétariat général répondra à votre demande dans un délai de 15 jours
ouvrables à compter de la date d’enregistrement de votre demande, et vous
informera de cet enregistrement (ou vous indiquera toute information
supplémentaire à fournir en vue de l'enregistrement et/ou du traitement de
votre demande).
Ihre Nachricht ist beim Referat „Transparenz“ des Generalsekretariats der
Europäischen Kommission eingegangen.
Anträge auf Zugang zu Dokumenten werden auf der Grundlage der
[3]Verordnung (EG) Nr. 1049/2001 vom 30. Mai 2001 über den Zugang der
Öffentlichkeit zu Dokumenten des Europäischen Parlaments, des Rates und
der Kommission behandelt.
Das Generalsekretariat beantwortet Ihre Anfrage innerhalb von
15 Arbeitstagen nach deren Registrierung und wird Sie über die
Registrierung Ihres Antrags (oder die Notwendigkeit weiterer Informationen
im Hinblick auf dessen Registrierung und/oder Bearbeitung) unterrichten.
References
Visible links
1. https://eur-lex.europa.eu/legal-content/...
2. https://eur-lex.europa.eu/legal-content/...
3. https://eur-lex.europa.eu/legal-content/...
Dear Sir or Madam,
We hereby acknowledge the receipt of your request for access to documents
sent on 08/12/2023 and registered on 08/12/2023 under the case number
2023/7286.
We will handle your request within 15 working days as of the date of
registration. The time-limit expires on 09/01/2024. We will let you know
if we need to extend this time limit for additional 15 working days.
To find more information on how we process your personal data, please see
[1]the privacy statement.
Yours faithfully,
Secretariat-General - Access to Documents
European Commission
References
Visible links
1. https://ec.europa.eu/info/principles-and...
Dear Ms Lauber,
We are writing concerning your request for access to Commission documents
registered on 13 December 2023 under case number EASE 2023/7362.
We are currently working on your request. However, we have not yet been
able to gather all the elements necessary to carry out a full analysis of
your request. We will not be able to send you the reply within the
prescribed time limit expiring on 9 January 2024.
An extended time limit is needed due to internal consultations and
thorough analysis of your request.Therefore, in line with Article 7(3) of
[1]Regulation (EC) No 1049/2001, we need to extend this time limit by 15
additional working days. The new time limit expires on 30 January 2024.
We apologise for any inconvenience this may cause.
Kind regards,
SANTE CONSULT D.1
References
Visible links
1. https://eur-lex.europa.eu/legal-content/...
Dear Ms Lauber,
please find attached a response to your request for access to Commission
documents registered under case number 2023/7286.
Please confirm the receipt by return mail.
Kind regards,
ENV.C.3 - Clean Air and Urban Policy
Dear Ms Lauber,
please find attached a response to your request for access to Commission
documents registered under case number 2023/7286.
Please confirm the receipt by return mail.
Kind regards,
ENV.C.3 - Clean Air and Urban Policy
Dear Ms Lauber,
We are writing concerning your request for access to Commission documents
registered on 12 December 2023 under case number 2023/7358.
We are currently working on your request. However, we have not yet been
able to gather all the elements necessary to carry out a full analysis of
your request and to send you the reply within the prescribed time limit
expiring on 09 January 2024.
An extended time limit is needed due to internal consultations and
thorough analysis of your request. Therefore, in line with Article 7(3) of
[1]Regulation (EC) No 1049/2001, we need to extend this time limit by 15
additional working days. The new time limit expires on 30 January 2024.
We apologise for any inconvenience this may cause.
Kind regards,
Secretary-General, Unit E4
References
Visible links
1. https://eur-lex.europa.eu/TodayOJ/
Dear Ms Lauber,
Thank you for your request for access to documents with reference
2023/7362.
We acknowledge that the time limit expired on 30/01/24, and apologise in
advance for the delay.
The consultation of the documents falling within the scope of your request
required more time.
We would like to inform you that your request is being handled. At this
moment the documents have been identified and assessed and the reply will
be sent to you as soon as it is signed at the appropriate level.
Please be reassured that we are doing our utmost to provide you with the
required documents as soon as possible.
Thank you very much for your understanding.
Kind regards,
Unit “Medicines: policy, authorisation and monitoring“
[1]logo-ce-horizontal-en-quadri-jpg24
European Commission
DG Health and Food Safety
References
Visible links
Dear Ms Lauber,
Please find attached the reply to your request for access to Commission
documents registered under the above-mentioned case number 2023/7362.
Due to the size of some of the files, you will receive some of them by
e-mail from our functional mailbox.
Yours sincerely,
Unit D.1
Dear Ms Lauber,
Please find attached the reply to your request for access to Commission
documents registered under the above-mentioned case number 2023/7362.
Due to the size of some of the files, you will receive some of them by
e-mail from our functional mailbox.
Yours sincerely,
Unit D.1
Dear Ms Lauber,
Please find attached the reply to your request for access to Commission
documents registered under the above-mentioned case number 2023/7362.
Due to the size of some of the files, you will receive some of them by
e-mail from our functional mailbox.
Yours sincerely,
Unit D.1
Dear Ms Lauber,
Please find attached the reply to your request for access to Commission
documents registered under the above-mentioned case number 2023/7362.
Due to the size of some of the files, you will receive some of them by
e-mail from our functional mailbox.
Yours sincerely,
Unit D.1
Dear Ms Lauber,
Please find attached the reply to your request for access to Commission
documents registered under the above-mentioned case number 2023/7362.
Due to the size of some of the files, you will receive some of them by
e-mail from our functional mailbox.
Yours sincerely,
Unit D.1
Dear Ms Lauber,
Please find attached the reply to your request for access to Commission
documents registered under the above-mentioned case number 2023/7362.
Due to the size of some of the files, you will receive some of them by
e-mail from our functional mailbox.
Yours sincerely,
Unit D.1
Dear Ms Lauber,
Please find attached the reply to your request for access to Commission
documents registered under the above-mentioned case number 2023/7362.
Due to the size of some of the files, you will receive some of them by
e-mail from our functional mailbox.
Yours sincerely,
Unit D.1
Dear Ms Lauber,
Please find enclosed the missing files for your application for case
2023/7362.
Kind regards,
Unit “Medicines: policy, authorisation and monitoring“
[1]logo-ce-horizontal-en-quadri-jpg24
European Commission
DG Health and Food Safety
References
Visible links
Dear Ms Lauber,
Please find enclosed the missing files for your application for case
2023/7362.
Kind regards,
Unit “Medicines: policy, authorisation and monitoring“
[1]logo-ce-horizontal-en-quadri-jpg24
European Commission
DG Health and Food Safety
References
Visible links
Dear Ms Lauber,
Please find enclosed the missing files for your application for case
2023/7362.
Kind regards,
Unit “Medicines: policy, authorisation and monitoring“
[1]logo-ce-horizontal-en-quadri-jpg24
European Commission
DG Health and Food Safety
References
Visible links
Dear Ms Lauber,
Please find enclosed the missing files for your application for case
2023/7362.
Kind regards,
Unit “Medicines: policy, authorisation and monitoring“
[1]logo-ce-horizontal-en-quadri-jpg24
European Commission
DG Health and Food Safety
References
Visible links
Dear Ms Lauber,
Please find enclosed the missing files for your application for case
2023/7362.
Kind regards,
Unit “Medicines: policy, authorisation and monitoring“
[1]logo-ce-horizontal-en-quadri-jpg24
European Commission
DG Health and Food Safety
References
Visible links
Dear Ms Lauber,
Please find enclosed the last missing file for your application for case
2023/7362.
Kind regards,
Unit “Medicines: policy, authorisation and monitoring“
[1]logo-ce-horizontal-en-quadri-jpg24
European Commission
DG Health and Food Safety
References
Visible links