ENVote in the European Parliament
Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
Overall Result
Adopted- 495 For
- 57 Against
- 45 Abstention
- 108 Did not vote
How we count
- Yes, No and Abstention come from the European Parliament's roll-call voting protocol.
- “Did not vote” is derived: MEPs with a mandate on the voting day for whom no vote was recorded. Abstentions do not count towards this.
- Subsequent vote corrections are shown but do not change the official result.
- Each vote (overall vote, amendment, partial vote) counts separately. Therefore totals may differ from pages that count differently.
Status and procedure
Outcome as recorded by the European Parliament.
- Vote held on
- Latest recorded step
- Committee stage · (32 days ago)
- Next scheduled step
- Plenary · (in 12 days)
Procedure timeline
2023/0132(COD) · COD
Recorded procedure activities. These do not establish whether a law has entered into force.
- Recorded: Referral
- Recorded: Committee stage
- Recorded: Plenary
- Recorded: Negotiations
- Recorded: Committee stage
- Recorded: Referral
- Latest recorded: Committee stage
- Planned: Plenary
Recorded activities (21)
- Referral to committee
- Committee report tabled
- Committee amendments tabled
- Committee amendments tabled
- Committee amendments tabled
- Committee amendments tabled
- Committee opinion adopted
- Committee opinion adopted
- Committee report adopted
- Tabling for plenary
- Parliament’s first-reading position with amendments
- Plenary debate
- Plenary vote
- Plenary vote results
- Interinstitutional negotiations
- Interinstitutional negotiations
- Interinstitutional negotiations
- Interinstitutional negotiations
- Provisional agreement approved in committee
- Referral to committee
- Committee report tabled
Scheduled activities (not confirmation of completion)
- Plenary debate
- Plenary vote
- Plenary vote
Procedure file (OEIL) · European Parliament data
Retrieved:
Sources
Data: EP Open Data API
What is this about?
- Revision of the EU pharmaceutical codex after 20 years.
- Focus on innovation , access and environmental sustainability .
- Strengthening strategic autonomy in the health sector.
Amendment history (4)
Wording as published by the EP, in English.
- Amendment 339Rejected
Recital 11
Tabled by Aurélia Beigneux, Anders Vistisen · ID
… enable innovation and promote competitiveness of the Union pharmaceutical industry, in particular
Removed: SMEs.Added: SMEs or other marketing authorisation holders producing on the EU territory regardless of their size. In this respect a balanced system of incentives is proposed that rewards … medical need and innovation that reaches patients and improves access across theRemoved: Union.Added: Union and its Outermost regions. To make the regulatory system more efficient and innovation-friendly the Directive also … - Amendment 343Rejected
Article 63 – paragraph 3
Tabled by Annalisa Tardino, Anders Vistisen, Aurélia Beigneux · ID
3.
Removed: Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State,Added: By default, a package leaflet in paper format shall be included in the packaging of a medicinal product.Removed: IfAdded: Member States may decide that the package leafletRemoved: is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of chargeAdded: shall be made available electronically as well, and it should be ensured that the information in digital format is … - Amendment 345Rejected
Article 81 – paragraph 1
Tabled by Aurélia Beigneux, Annalisa Tardino, Anders Vistisen · ID
1. The regulatory data protection period shall be
Removed: sixAdded: eight years from the date when the marketing authorisation for that medicinal product … - Amendment 346Rejected
Article 82 – paragraph 1 – subparagraph 1
Tabled by Aurélia Beigneux, Anders Vistisen · ID
… point (a), shall only be granted to medicinal products if they are
Removed: released and continuouslyAdded: continuously produced and supplied into the supply chain Added: by marketing authorisation holders regardless of their size in a sufficient quantity and in the presentations necessary to cover the …
Vote by political group
How the political groups voted
Progressive Alliance of Socialists and Democrats (S&D)- 116For
- 5Against
- 0Abstention
- 18Did not vote
European People's Party (EPP)- 143For
- 3Against
- 0Abstention
- 31Did not vote
Non-attached Members (NI)- 96For
- 22Against
- 28Abstention
- 39Did not vote
Renew Europe (Renew)- 91For
- 1Against
- 0Abstention
- 10Did not vote
Greens/European Free Alliance (Greens/EFA)- 30For
- 2Against
- 0Abstention
- 1Did not vote
European Conservatives and Reformists (ECR)- 14For
- 3Against
- 9Abstention
- 5Did not vote
The Left in the European Parliament (GUE/NGL)- 5For
- 7Against
- 0Abstention
- 1Did not vote
Identity and Democracy (ID)- 0For
- 14Against
- 8Abstention
- 3Did not vote
Members
Showing 10 of 705
| Name | Country | Group | Vote Position |
|---|---|---|---|
 Portugal | S&D | For | |
 Germany | EPP | For | |
 Spain | NI | For | |
 Romania | Renew | For | |
 Belgium | Renew | For | |
| Portugal | EPP | For | |
 France | Renew | For | |
| France | EPP | For | |
 Hungary | S&D | For | |
 Italy | EPP | For |
