2023/0127(COD)
Unitary supplementary certificate for medicinal products
Basic information
2023/0127(COD)
COD - Ordinary legislative procedure (ex-codecision procedure)
Regulation
Amending Regulation 2006/1901
2004/0217(COD)
Amending Regulation 2013/608
2011/0137(COD)
Amending Regulation 2017/1001
2016/0345(COD)
Subject
3.50.15 Intellectual property, copyright
3.50.16 Industrial property, European patent, Community patent, design and pattern
4.20.04 Pharmaceutical products and industry
Status
Awaiting Council's 1st reading position
Key players
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European Parliament
Committee responsible Rapporteur Appointed JURIWÖLKEN Tiemo (S&D)
18/11/2024
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Former committee responsible Former rapporteur Appointed JURI
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Former committee for opinion Former rapporteur for opinion Appointed INTAThe committee decided not to give an opinion. The committee decided not to give an opinion. The committee decided not to give an opinion.
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European Commission
Commission DG Commissioner Internal Market, Industry, Entrepreneurship and SMEs BRETON Thierry
Key events
| Date | Event | Reference | Summary |
|---|---|---|---|
| 27/04/2023 | Legislative proposal published | COM(2023)0222 | |
| 11/09/2023 | Committee referral announced in Parliament, 1st reading | ||
| 24/01/2024 | Vote in committee, 1st reading | ||
| 31/01/2024 | Committee report tabled for plenary, 1st reading | A9-0019/2024 | |
| 27/02/2024 | Debate in Parliament | ||
| 28/02/2024 | Decision by Parliament, 1st reading | T9-0097/2024 | |
| 28/02/2024 | Results of vote in Parliament | ||
| 13/11/2024 | Committee referral announced in Parliament, 1st reading |
Technical information
| Procedure | Information |
|---|---|
| Procedure reference | 2023/0127(COD) |
| Procedure type | COD - Ordinary legislative procedure (ex-codecision procedure) |
| Nature of procedure | Legislation |
| Legislative instrument | Regulation |
|
Amending Regulation 2006/1901
2004/0217(COD)
Amending Regulation 2013/608 2011/0137(COD) Amending Regulation 2017/1001 2016/0345(COD) |
|
| Legal basis | Treaty on the Functioning of the EU TFEU 118-p1 |
| Other legal basis | Rules of Procedure EP 165 |
| Stage reached in procedure | Awaiting Council's 1st reading position |
| Committee dossier |
JURI/9/11896
|
Documentation gateway
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Document type Committee Reference Date Summary Committee draft report PE753.703 13/10/2023 Amendments tabled in committee PE756.103 13/11/2023 Committee report tabled for plenary, 1st reading/single reading A9-0019/2024 31/01/2024 Text adopted by Parliament, 1st reading/single reading T9-0097/2024 28/02/2024 -
Document type Reference Date Summary Document attached to the procedure SWD(2023)0119 27/04/2023 Legislative proposal COM(2023)0222 27/04/2023 Document attached to the procedure SWD(2023)0118 27/04/2023 Document attached to the procedure SWD(2023)0117 27/04/2023 Commission response to text adopted in plenary SP(2024)270 08/07/2024 -
Document type Parliament/Chamber Reference Date Summary Contribution DE_BUNDESRAT COM(2023)0222 09/11/2023 -
Institution/body Document type Reference Date Summary ESC Economic and Social Committee: opinion, report CES2306/2023 20/09/2023
Transparency
Meetings with interest representatives published in line with the Rules of Procedure
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Name Role Committee Date Interest representatives ZARZALEJOS Javier Shadow rapporteur JURI 23/01/2024 Chamber of Commerce of the United States of America ZARZALEJOS Javier Shadow rapporteur JURI 05/12/2023 European Federation of Pharmaceutical Industries and Associations ZARZALEJOS Javier Shadow rapporteur JURI 04/12/2023 Bristol-Myers Squibb Company ZARZALEJOS Javier Shadow rapporteur JURI 08/11/2023 European Federation of Pharmaceutical Industries and Associations VÁZQUEZ LÁZARA Adrián Shadow rapporteur JURI 08/11/2023 MEDICINES FOR EUROPE ZARZALEJOS Javier Shadow rapporteur JURI 07/11/2023 Johnson & Johnson ZARZALEJOS Javier Shadow rapporteur JURI 06/11/2023 Bristol-Myers Squibb Company WÖLKEN Tiemo Rapporteur JURI 11/10/2023 EUIPO WÖLKEN Tiemo Rapporteur JURI 04/10/2023 Bristol-Myers Squibb Company WÖLKEN Tiemo Rapporteur JURI 19/07/2023 European Federation of Pharmaceutical Industries and Associations
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Name Date Interest representatives WÖLKEN Tiemo 26/06/2023 Permanent Representation of the Federal Republic of Germany to the European Union