Dossier · Ordinary legislative procedure
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
- Reference
- 2023/0127(COD) Ordinary legislative procedure
- Where it stands
- 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.
- Stage
- First reading
- Lead committee
- Legal Affairs JURI
More facts (5)
- Rapporteur
- Tiemo WÖLKEN
- Shadow rapporteurs
- 4 members
- Decisions in plenary
- None yet
- Versions
- 3 versions
- Opinions from
- IMCO, ENVI, INTA
Where it stands
The steps of this kind of dossier and how far it has come, from the procedure file.
- 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)
A proposed EU law. Parliament and the Council must agree on the same text: Parliament adopts its position, then negotiates with the Council.
People
Committees and members responsible for the dossier, as the procedure file names them. Groups as recorded there.
- Lead committee
- Legal Affairs JURI
- Rapporteur
- Tiemo WÖLKEN (S&D)
- Shadow rapporteurs
- Javier ZARZALEJOS (EPP), Adrián VÁZQUEZ LÁZARA (Renew), Marie TOUSSAINT (Greens), MEP #24505 (The Left) former member
- Opinion: IMCO
- Internal Market and Consumer Protection
- Opinion: ENVI
- Environment, Climate and Food Safety
- Opinion: INTA
- International Trade
Decisions in plenary, 0
Every decision Parliament took on this dossier, newest first.
No plenary decision on this dossier is in the records yet.
Every roll-call vote on the dossier, in date and voting order, with each group's line at the date of the vote.
No roll-call vote was recorded on this dossier.
Add members’ columns
Versions, 3
The text of the dossier, version by version, newest first. Compare shows what changed between two consecutive versions.
Adopted by Parliament28 Feb 2024
Adopted text TA9-0097/2024 TA-9-2024-0097
Tabled for plenary31 Jan 2024
Report A9-0019/2024 A-9-2024-0019
Committee draft13 Oct 2023
Draft report (JURI) JURI-PR-753703
AI: Each version in short Written by AI from the official text — check the source
- Report A9-0019/2024: 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.
What changed
Between consecutive versions of the text, newest pair first.
No overview of what changed between versions is available for this dossier. The “Compare” links under Versions show every change between two versions.
Timeline, 7
Every recorded step, newest first, grouped by stage; the latest stage is open.
Plenary stage 3 steps · 31 Jan 2024–28 Feb 2024
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 · 11 Sept 2023–24 Jan 2024
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.
Connections
Texts, decisions, people and other dossiers related to this one.
No connections found for this item.
Sources & citation
Where the facts on this page come from, and how to cite it.
- Official source
- Data source
- Licensed CC BY 4.0.
- Retrieved
- 25 September 2026
Cite as
European Parliament (2026). “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”. Dossier. reference 2023/0127(COD). EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/dossiers/2023-0127 (retrieved 25 September 2026). Official source: Legislative Observatory (OEIL), 2023/0127(COD), https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2023%2F0127(COD). Data: European Parliament Open Data, https://data.europarl.europa.eu/ (CC BY 4.0).
BibTeX
@misc{epw-dossier-2023-0127,
author = {{European Parliament}},
title = {{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}},
year = {2026},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/dossiers/2023-0127}},
url = {https://news.eu-parl.st-solutions.dev/dossiers/2023-0127},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Dossier. reference 2023/0127(COD). Official source: https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2023\%2F0127(COD). Data: European Parliament Open Data (CC BY 4.0)}
}