Documentation regarding general pharmaceutical legislation revision

Kathrin Lauber made this access to documents request to Health and Food Safety

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The request was partially successful.

Dear DG SANTE access to documents team,

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting the following documents regarding the revision of the general pharmaceutical legislation.

Specifically, I would like to request the following:
(1) Any written correspondence from external stakeholders which directly concerns the revision of the general pharmaceutical legislation, and DG SANTE’s response, if it made any. Please include any documents attached to such correspondence.
(2) Any and all drafts of the consultation strategies for the revision of the general pharmaceutical legislation and the Pharmaceutical Strategy.
(3) A list of all stakeholder meetings that have fed into the revision process from 5 October 2022 onwards, as well as the agendas and minutes of these meetings. Where minutes and or/agendas were not created or are not held by DG SANTE, I would be grateful if this could be indicated. Please note that this is complementary to another access-to-documents request (2022/5670, currently under internal review) which covered the period up to 5th October.

As per Article 4(1)(b) Regulation 1049/2001, please redact the names/initials and contact information of Commission staff members not pertaining to senior management, as well as representatives of stakeholder groups.

If you have any questions or require clarification of the scope of the request, please do not hesitate to contact me. I would be glad to discuss the request and refine its parameters if appropriate. In case it is helpful to have some context, we are seeking to better understand the Commission’s stakeholder engagement processes as part of a research project.

Yours sincerely,

Dr Kathrin Lauber
University of Edinburgh, School of Social and Political Science
Chrystal Macmillan Building
15a George Square
EH8 9LD, Edinburgh

SANTE-ACCESS-TO-DOCUMENTS@ec.europa.eu,

Dear Sir or Madam,

We hereby acknowledge the receipt of your request for access to documents
sent on 17/05/2023 and registered on 22/05/2023 under the case number
2023/2969.

We will handle your request within 15 working days as of the date of
registration. The time-limit expires on 13/06/2023. 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,

Directorate-General for Health and Food Safety - Access to Documents
European Commission

References

Visible links
1. https://ec.europa.eu/info/principles-and...

SANTE-ACCESS-TO-DOCUMENTS@ec.europa.eu,

1 Attachment

Dear Ms Lauber,

Please find the extension of deadline letter enclised.

kind regards,

UNIT D1

SANTE-PHARMA-POLICY@ec.europa.eu, Health and Food Safety

4 Attachments

Our reference: Ares(2023)4605380

 

Dear Ms Lauber,

 

Please find attached a letter with the attachments on the above mentioned
subject.

 

Due to the big amount of documents you will receive 6 separate e-mails.

 

According to the standard operational procedure, the reply is sent by
e-mail only.

 

We would therefore appreciate if you could explicitly confirm receipt of
the e-mail within 5 working days by replying to
[email address].

 

Kind regards,

 

Unit “Medicines: policy, authorisation and monitoring“

[1]logo-ce-horizontal-en-quadri-jpg24

 

European Commission

DG Health and Food Safety

show quoted sections

SANTE-PHARMA-POLICY@ec.europa.eu, Health and Food Safety

2 Attachments

Our reference: Ares(2023)4605380

 

Dear Ms Lauber,

 

Please find attached the documents in a Zip file on the above mentioned
subject.

 

Due to the big amount of documents you will receive 6 separate e-mails.

 

According to the standard operational procedure, the reply is sent by
e-mail only.

 

We would therefore appreciate if you could explicitly confirm receipt of
the e-mail within 5 working days by replying to
[email address].

 

Kind regards,  

 

Unit “Medicines: policy, authorisation and monitoring“

[1]logo-ce-horizontal-en-quadri-jpg24

 

European Commission

DG Health and Food Safety

show quoted sections

SANTE-PHARMA-POLICY@ec.europa.eu, Health and Food Safety

2 Attachments

Our reference: Ares(2023)4605380

 

Dear Ms Lauber,

 

Please find attached the documents in a Zip file on the above mentioned
subject.

 

Due to the big amount of documents you will receive 6 separate e-mails.

 

According to the standard operational procedure, the reply is sent by
e-mail only.

 

We would therefore appreciate if you could explicitly confirm receipt of
the e-mail within 5 working days by replying to
[email address].

 

Kind regards,

 

Unit “Medicines: policy, authorisation and monitoring“

[1]logo-ce-horizontal-en-quadri-jpg24

 

European Commission

DG Health and Food Safety

show quoted sections

SANTE-PHARMA-POLICY@ec.europa.eu, Health and Food Safety

2 Attachments

Our reference: Ares(2023)4605380

 

Dear Ms Lauber,

 

Please find attached the documents in a Zip file on the above mentioned
subject.

 

Due to the big amount of documents you will receive 6 separate e-mails.

 

According to the standard operational procedure, the reply is sent by
e-mail only.

 

We would therefore appreciate if you could explicitly confirm receipt of
the e-mail within 5 working days by replying to
[email address].

 

Kind regards,

 

Unit “Medicines: policy, authorisation and monitoring“

[1]logo-ce-horizontal-en-quadri-jpg24

 

European Commission

DG Health and Food Safety

show quoted sections

SANTE-PHARMA-POLICY@ec.europa.eu, Health and Food Safety

2 Attachments

Our reference: Ares(2023)4605380

 

Dear Ms Lauber,

 

Please find attached the documents in a Zip file on the above mentioned
subject.

 

Due to the big amount of documents you will receive 6 separate e-mails.

 

According to the standard operational procedure, the reply is sent by
e-mail only.

 

We would therefore appreciate if you could explicitly confirm receipt of
the e-mail within 5 working days by replying to
[email address].

 

Kind regards,

 

Unit “Medicines: policy, authorisation and monitoring“

[1]logo-ce-horizontal-en-quadri-jpg24

 

European Commission

DG Health and Food Safety

show quoted sections

SANTE-PHARMA-POLICY@ec.europa.eu, Health and Food Safety

2 Attachments

Our reference: Ares(2023)4605380

 

Dear Ms Lauber,

 

Please find attached the documents in a Zip file on the above mentioned
subject.

 

Due to the big amount of documents you will receive 6 separate e-mails.

 

According to the standard operational procedure, the reply is sent by
e-mail only.

 

We would therefore appreciate if you could explicitly confirm receipt of
the e-mail within 5 working days by replying to
[email address].

 

Kind regards,

 

Unit “Medicines: policy, authorisation and monitoring“

[1]logo-ce-horizontal-en-quadri-jpg24

 

European Commission

DG Health and Food Safety

show quoted sections

Dear DG Health and Food Safety,

Many thanks for sending these documents. I hereby acknowledge that all 104 documents have been received.

Yours sincerely,
Kathrin Lauber