2023/0127(COD)COM(2023)222JURI

Unitary supplementary certificate for medicinal products

Unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013

Stage: EP position adopted, reached 28 Feb 2024
Procedure: Regulation · 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. 118; TFEU_2016 Art. 118(1); TFEU_2016 Art. 294

51 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
1 Aug 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
13 Nov 2023
- Committee amendments tabled
- Tabling of amendments in the EP committee responsible
24 Jan 2024
- Committee report adopted
31 Jan 2024
- Tabled for plenary
1 Feb 2024
- Discussions within the Council or its preparatory bodies
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
30 Jan 2025
- Discussions within the Council or its preparatory bodies
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
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
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 · Council
22 May 2026
- Deliberations in Council working party
27 May 2026
- Deliberations in Coreper · Council
28 May 2026
- Deliberations in Council · Council
4 Jun 2026
- Deliberations in Council working party · Council
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

5 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

168 amendments

Amendments

Tabled on 13 Nov 2023. The texts are in the amendment documents below.

By committee

JURI168

By author

Javier Zarzalejos62
Daniel Buda49
Marie Toussaint25
Raffaele Stancanelli17
Adrián Vázquez Lázara15

Amendments each member tabled or co-signed.

By article

Article 28 – paragraph 34
Article 13 – paragraph 23
Article 18 – paragraph 1 – introductory part3
Article 35 – paragraph 1 – point i a (new)3
Article 35 – paragraph 1 – point l3
Article 35 – paragraph 1 – point m3
Article 35 – paragraph 8 a (new)3
Article 41 – paragraph 23
Article 56 – paragraph 13
Article 12 – paragraph 12

Show 20 more provisions

Article 13 – paragraph 12
Article 13 – paragraph 32
Article 13 – paragraph 5 a (new)2
Article 14 – paragraph 32
Article 15 – paragraph 102
Article 15 – paragraph 10 a (new)2
Article 15 – paragraph 122
Article 15 – paragraph 13 a (new)2
Article 15 – paragraph 62
Article 15 – paragraph 82
Article 17 – paragraph 3 – point c2
Article 232
Article 23 – paragraph 32
Article 242
Article 29 – paragraph 42
Article 35 – paragraph 1 – point k a (new)2
Article 35 – paragraph 1 – point n2
Article 35 – paragraph 1 – point r a (new)2
Article 35 – paragraph 7 – point b2
Article 41 – paragraph 32

Covers 70 of the 168 amendments.

6 documents

Documents

Newest first. Each opens at its source.

Text adopted · T9-0097/2024Parliament · 27 Feb 2024
Report · A9-0019/2024Parliament · 24 Jan 2024
Report · PE753.703Parliament · 13 Oct 2023
Amendments · PE756.103Parliament · 13 Oct 2023
Proposal · COM(2023)0222Commission · 27 Apr 2023
Text adopted · SP(2024)270Parliament

Summary

Generated

This regulation creates a unitary supplementary certificate for medicinal products, extending EU-wide patent and trademark protection for innovative drugs. It streamlines approval across member states, strengthening public health outcomes and ensuring consistent market exclusivity for pharmaceutical companies. The European Parliament has adopted its position; the file is now with the Council.

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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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