2023/0130(COD)COM(2023)231JURI

Supplementary protection certificate for medicinal products. Recast

Supplementary protection certificate for medicinal products (recast)

Stage: EP position adopted, reached 28 Feb 2024
Procedure: OLP · Ordinary legislative procedure
Rapporteur: Tiemo Wölken (S&D)
Lead DG: DG GROW
Commissioner: Stéphane Séjourné
Council configuration: Competitiveness Council
Last activity: 4 Sept 2026
Legal basis: TFEU_2016 Art. 114; TFEU_2016 Art. 114(1); TFEU_2016 Art. 294

52 entries · record as of 14 Sept 2026

Where it stands

Latest: Deliberations in Council working party, 4 Sept 2026.

Show the earlier record: 39 dates, 27 Apr 2023 to 31 Mar 2026

27 Apr 2023
- Adoption of legislative proposal by the Commission
28 Apr 2023
- Discussions within the Council or its preparatory bodies
14 Jul 2023
- Discussions within the Council or its preparatory bodies
11 Sept 2023
- Referred to committee
25 Sept 2023
- Discussions within the Council or its preparatory bodies
13 Oct 2023
- Committee report tabled
- EP committee draft report
16 Oct 2023
- Discussions within the Council or its preparatory bodies
7 Nov 2023
- Committee opinion adopted
14 Nov 2023
- Committee amendments tabled
- Tabling of amendments in the EP committee responsible
24 Jan 2024
- Committee report adopted
1 Feb 2024
- Discussions within the Council or its preparatory bodies
- Tabled for plenary
27 Feb 2024
- Debate in plenary
28 Feb 2024
- EP position at first reading
- Plenary amended the proposal
- Plenary vote
2 Jul 2024
- Discussions within the Council or its preparatory bodies
11 Jul 2024
- Discussions within the Council or its preparatory bodies
13 Nov 2024
- Referred to committee
28 Nov 2024
- Deliberations in Council
18 Dec 2024
- Deliberations in Coreper
10 Apr 2025
- Deliberations in Council working party
28 Apr 2025
- Deliberations in Council working party
8 May 2025
- Deliberations in Council working party
2 Jun 2025
- Deliberations in Council working party
3 Jun 2025
- Deliberations in Council working party
23 Jun 2025
- Deliberations in Council working party
2 Jul 2025
- Deliberations in Council working party
3 Jul 2025
- Deliberations in Council working party
5 Sept 2025
- Deliberations in Council working party
3 Oct 2025
- Deliberations in Council working party
20 Oct 2025
- Deliberations in Council working party
21 Oct 2025
- Retained as a pending proposal in the Commission work programme · Commission
3 Nov 2025
- Deliberations in Council working party
17 Nov 2025
- Deliberations in Council working party
5 Dec 2025
- Deliberations in Council working party
8 Dec 2025
- Deliberations in Council
21 Jan 2026
- Deliberations in Council working party
6 Feb 2026
- Deliberations in Council working party
18 Feb 2026
- Deliberations in Council working party
18 Mar 2026
- Deliberations in Council working party
31 Mar 2026
- Deliberations in Council working party

27 Apr 2026
- Deliberations in Council working party
22 May 2026
- Deliberations in Council working party
27 May 2026
- Deliberations in Coreper
28 May 2026
- Deliberations in Council
4 Jun 2026
- Deliberations in Council working party
22 Jun 2026
- Deliberations in Council working party
3 Jul 2026
- Deliberations in Council working party · Council
4 Sept 2026
- Deliberations in Council working party · Council

6 people

Who is on it

The Parliament's rapporteurs, shadow rapporteurs and opinion rapporteurs currently on this file.

Role	Name	Group	Country	Committee
Rapporteur	Tiemo Wölken	S&D	DE	JURI
Shadow rapporteur	Adrián Vázquez Lázara	Renew	ES	JURI
Shadow rapporteur	Emmanuel Maurel	The Left	FR	JURI
Shadow rapporteur	Javier Zarzalejos	EPP	ES	JURI
Shadow rapporteur	Marie Toussaint	Greens/EFA	FR	JURI
Rapporteur for opinion	Magdalena Adamowicz	EPP	PL	JURI

108 amendments

Amendments

Tabled on 14 Nov 2023. The texts are in the amendment documents below.

By committee

JURI108

By author

Daniel Buda51
Javier Zarzalejos38
Marie Toussaint19

Amendments each member tabled or co-signed.

By article

Recital 243
Article 28 – paragraph 3 – point c2
Article 29 – paragraph 32
Article 29 – paragraph 52
Article 32 – paragraph 12
Article 35 – paragraph 11 a (new)2
Article 35 – paragraph 2 – point j a (new)2
Article 35 – paragraph 2 – point n2
Article 44 – paragraph 22
Article 57 – paragraph 22

Show 20 more provisions

Article 8 – paragraph 1 – point d a (new)2
Recital 132
Recital 32
Recital 52
Recital 602
Recital 82
Recital 92
Article 11 – paragraph 1 a (new)1
Article 11 – paragraph 1 – point f a (new)1
Article 15 – paragraph 1 – point a1
Article 15 – paragraph 1 – point c a (new)1
Article 16 – paragraph 21
Article 18 – paragraph 2 a (new)1
Article 2 – paragraph 1 – point 12 a (new)1
Article 20 – paragraph 11
Article 23 – paragraph 11
Article 24 – paragraph 11
Article 24 – paragraph 21
Article 24 – paragraph 31
Article 24 – paragraph 5 a (new)1

Covers 48 of the 108 amendments.

7 documents

Documents

Newest first. Each opens at its source.

Text adopted · T9-0099/2024Parliament · 27 Feb 2024
Report · A9-0022/2024Parliament · 24 Jan 2024
Amendments · PE756.105Parliament · 9 Nov 2023
Report · PE753.704Parliament · 13 Oct 2023
Committee opinion · PE756.057Parliament · 13 Oct 2023
Proposal · COM(2023)0231Commission · 27 Apr 2023
Text adopted · SP(2024)270Parliament

Summary

Generated

This recast regulation harmonizes supplementary protection certificates across the EU, extending market exclusivity for patented medicinal products. It aims to balance legal certainty for pharmaceutical innovators with public health objectives and timely access to medicines.

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Sources: EP Legislative Observatory · EU Law Tracker. Record as of 14 Sept 2026. Something wrong on this page? Report an error.

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