Procedure

Authorisation and supervision of medicinal products for human use and governing rules for the European Medicines Agency

2023/0131(COD)·9th term·ENVI / ITRE·COD - Ordinary legislative procedure (ex-codecision procedure)·In progressAwaiting Council's 1st reading position
Rapporteur (the Member appointed to lead Parliament's work on this text): WÖLKEN Tiemo (S&D)
Summary

This dossier covers the authorisation and supervision of medicinal products for human use and governing rules for the European Medicines Agency. The amendments rework the modulation of market exclusivity for orphan medicinal products addressing high unmet needs, invoke the Pharmaceutical Strategy for Europe and the One Health approach, and address shortages, security of supply, generics and biosimilars, paediatric studies, and cross-border access.

Procedure timeline

  1. Committee amendments tabled
    21 Nov 2023 – 30 Nov 2023
  2. Plenary vote — Adopted
    10 Apr 2024 · On the Commission proposal (the draft law)
  3. In progress — not yet concluded
2,004
Amendments
distinct, in window
58
Members
tabled at least one
2
Committee(s)
21 Nov 2023 – 30 Nov 2023
Dates

Plenary votes

6 roll-call votes

In plenary, Parliament usually votes in steps: first on amendments to the text (sometimes split into parts, so Members can accept one half of a sentence and reject the other), then on the text as a whole. The “main vote” is the one that adopts or rejects the text itself. Each vote below shows exactly which step it was. How voting works →

  1. Show the 3 earlier votes
    1. 10 Apr 2024Rejected
      On amendment 373 — paragraph 3 — article 33
      Official label: Article 33, § 3 - Am 373 · what was voted ↗
      129 for459 against1 abstentions116 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    2. 10 Apr 2024Rejected
      On amendment 379 — article 40
      Official label: Après l'article 40 - Am 379 · what was voted ↗
      156 for334 against98 abstentions117 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    3. 10 Apr 2024Rejected
      On amendment 378 — text to be inserted before paragraph 1 — article 134
      Official label: Article 134, avant le § 1 - Am 378 · what was voted ↗
      96 for450 against36 abstentions123 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

  2. 10 Apr 2024Rejected
    On amendment 377 — text to be inserted after recital 3
    Official label: Après le considérant 3 - Am 377 · what was voted ↗
    73 for504 against15 abstentions113 did not vote
    For
    Against
    Abst.

    Click a group to see each Member’s position.

  3. 10 Apr 2024Rejected
    On amendment 368 — text to be inserted after recital 5
    Official label: Après le considérant 5 - Am 368 · what was voted ↗
    62 for443 against59 abstentions141 did not vote
    For
    Against
    Abst.

    Click a group to see each Member’s position.

  4. 10 Apr 2024Main voteAdopted
    On the Commission proposal (the draft law)
    Official label: Proposition de la Commission · what was voted ↗
    488 for67 against34 abstentions116 did not vote
    For
    Against
    Abst.

    Click a group to see each Member’s position.

Vote data: HowTheyVote.eu (ODbL, attribution) / European Parliament · roll-call votes only

Statistical baseline — not a forecast

How groups usually vote on similar files

Based on 2,388 past all main roll-call votes, Jul 2019 → 2026-07-04.

EPPusually FOR88% FOR over 383,644 votes
S&Dusually FOR92% FOR over 301,645 votes
Renewusually FOR91% FOR over 207,185 votes
Greens/EFAusually FOR85% FOR over 147,703 votes
ECRusually FOR60% FOR over 146,773 votes
The Leftusually FOR64% FOR over 84,375 votes
Patriotsusually AGAINST44% FOR over 43,438 votes
IDusually AGAINST37% FOR over 106,739 votes
ESNusually AGAINST30% FOR over 13,705 votes
Non-attachedusually FOR61% FOR over 77,201 votes

Statistical baseline from past roll-call votes; not a forecast. · roll-call votes only

Follow this procedure — subscribe to its votes (RSS)

Full record

Members who amended this procedure

58 Members · by amendment count
1🇪🇸
Susana SOLÍS PÉREZ
European People's Party (EPP) · Spain
271(14 solo)
2🇫🇷
Catherine AMALRIC
Renew Europe · France
213(2 solo)
3🇱🇺
Tilly METZ
Greens / EFA · Luxembourg
194(194 solo)
4🇫🇷
Max ORVILLE
Renew Europe · France
175
5🇮🇪
Billy KELLEHER
Renew Europe · Ireland
160
6🇧🇪
Frédérique RIES
Renew Europe · Belgium
146(15 solo)
7🇧🇬
Andrey SLABAKOV
European Conservatives & Reformists · Bulgaria
145(134 solo)
8🇭🇷
Tomislav SOKOL
European People's Party (EPP) · Croatia
144(113 solo)
9🇩🇰
Pernille WEISS
European People's Party (EPP) · Denmark
120(85 solo)
10🇸🇮
Klemen GROŠELJ
Renew Europe · Slovenia
120
11🇪🇸
Laura BALLARÍN CEREZA
Socialists & Democrats · Spain
89(2 solo)
12🇪🇸
Nicolás GONZÁLEZ CASARES
Socialists & Democrats · Spain
87
13🇩🇰
Erik POULSEN
Renew Europe · Denmark
86(4 solo)
14🇪🇸
Margarita DE LA PISA CARRIÓN
Patriots for Europe · Spain
85(85 solo)
15🇮🇹
Maria Angela DANZÌ
Non-attached · Italy
73(73 solo)
16🇨🇿
Kateřina KONEČNÁ
Non-attached · Czechia
73(73 solo)
17🇫🇮
Ville NIINISTÖ
Greens / EFA · Finland
61(61 solo)
18🇬🇷
Stelios KYMPOUROPOULOS
European People's Party (EPP) · Greece
58(28 solo)
19🇩🇪
Tiemo WÖLKEN
Socialists & Democrats · Germany
55(55 solo)
20🇨🇿
Ondřej KNOTEK
Patriots for Europe · Czechia
54
21🇮🇹
Fulvio MARTUSCIELLO
European People's Party (EPP) · Italy
54(54 solo)
22🇩🇰
Anders VISTISEN
Identity & Democracy · Denmark
53(51 solo)
23🇫🇷
Nathalie COLIN-OESTERLÉ
European People's Party (EPP) · France
45(45 solo)
24🇩🇪
Andreas GLÜCK
Renew Europe · Germany
43(18 solo)
25🇮🇹
Massimiliano SALINI
European People's Party (EPP) · Italy
43

The amendments, in full text

2,004 amendments

Every amendment as tabled — original text, proposed change and justification, with a link to the official PDF.

The full amendment texts load as you scroll here.