Where the law stands, Dossier 2023/0127(COD)
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
Ordinary legislative procedure (COD): Parliament and the Council decide together as equals. · First reading
A proposed EU law. Parliament and the Council must agree on the same text: Parliament adopts its position, then negotiates with the Council.
Where it stands
Plenary vote
Parliament adopted its first-reading position on 28 February 2024. Next: negotiations with the Council, unless the Council accepts Parliament’s text as it stands.
- Referred to committee(done) 11 September 2023
- Committee work(done) Report adopted 24 January 2024
- Tabled for plenary(done) 31 January 2024
- Plenary vote(done) Adopted 28 February 2024
- Negotiations with the Council(to come)
- Published as law(to come)
No plenary decision on this dossier is in our records yet.
Who works on it
- Lead committee
- Legal Affairs
- The MEP who drafts the report and negotiates it on behalf of the committee.
- Tiemo Wölken (S&D)
- An MEP who follows a report on behalf of their own group when another group holds the rapporteur.
- Javier Zarzalejos (EPP), Adrián Vázquez Lázara (Renew), Marie Toussaint (Greens), Mep #24505 (The Left)
- Committees giving an opinion
- Internal Market and Consumer Protection
- Environment, Climate and Food Safety
- International Trade
The text, version by version
Newest first.
Adopted by Parliament· 28 Feb 2024
Tabled for plenary· 31 Jan 2024
AI summary:Parliament's amended version of the Commission proposal for a regulation on the unitary supplementary certificate for medicinal products. It sets up a centralised electronic application and examination system run by the Office, with national examiners, and lays down rules on protection, opposition, appeal and fees.
Committee draft· 13 Oct 2023
Timeline
Newest first.
Plenary stage 3 steps
28 February 2024
Plenary vote
Sitting of 28 Feb 2024 Adopted text TA9-0097/2024Report A9-0019/2024
27 February 2024
Debated in plenary
MEPs debated the text in the chamber ahead of the vote.
Sitting of 27 Feb 2024 Council / Commission text C9-0146/2023Council / Commission text C9-0147/2023Council / Commission text C9-0148/2023Council / Commission text C9-0149/2023Council / Commission text C9-0152/2023Report A9-0016/2024Report A9-0019/2024Report A9-0020/2024Report A9-0022/2024Report A9-0023/2024
31 January 2024
Report tabled for plenary
This is the text all MEPs vote on. Political groups can still table amendments to it.
Committee stage 4 steps
24 January 2024
Committee vote: report adopted
JURI (Legal Affairs) voted on the amendments and adopted the report that goes to plenary.
13 November 2023
Amendments tabled in committee
Members of JURI (Legal Affairs) proposed changes to the draft.
13 October 2023
Draft report published
The rapporteur’s first text in JURI (Legal Affairs). Members can table amendments before the committee votes.
11 September 2023
Referred to the JURI (Legal Affairs) committee
The lead committee prepares the report; IMCO (Internal Market and Consumer Protection), ENVI (Environment, Climate and Food Safety), INTA (International Trade) give an opinion.
Official record: Legislative Observatory, 2023/0127(COD)