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Procedure

Medicinal products for human use

2023/0132(COD)·9th term·ENVI / ITRE·COD - Ordinary legislative procedure (ex-codecision procedure)·In progressAwaiting Council's 1st reading position
Subjects: Medicine, diseases · Pharmaceutical products and industry
Rapporteur (the Member appointed to lead Parliament's work on this text): MONTSERRAT Dolors (EPP)
Summary

A legislative dossier on medicinal products for human use. The amendments rework the regulatory data protection periods for new therapeutic indications and options, debating durations of one, two, two-and-a-half and four years, the clinical or non-clinical evidence of significant benefit, designation as a value added medicinal product, reporting of research and development costs, and the treatment of patent rights and supplementary protection certificates.

Procedure timeline

  1. Committee amendments tabled
    21 Nov 2023 – 1 Dec 2023
  2. Plenary vote — Adopted
    10 Apr 2024 · On the Commission proposal (the draft law)
  3. In progress — not yet concluded
1,844
Amendments
distinct, in window
64
Members
tabled at least one
2
Committee(s)
21 Nov 2023 – 1 Dec 2023
Dates

Plenary votes

8 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 5 earlier votes
    1. 10 Apr 2024Adopted
      On the lead committee's amendments — amendment 85
      Official label: Amendements de la commission compétente - vote séparé - Am 85 · what was voted ↗
      382 for199 against16 abstentions108 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    2. 10 Apr 2024Adopted
      On the lead committee's amendments — amendment 159 (part 1 of a split vote)
      Official label: Amendements de la commission compétente - vote séparé - Am 159/1 · what was voted ↗
      501 for81 against8 abstentions115 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    3. 10 Apr 2024Adopted
      On the lead committee's amendments — amendment 159 (part 2 of a split vote)
      Official label: Amendements de la commission compétente - vote séparé - Am 159/2 · what was voted ↗
      464 for123 against11 abstentions107 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    4. 10 Apr 2024Rejected
      On amendment 343 — paragraph 3 — article 63
      Official label: Article 63, § 3 - Am 343 · what was voted ↗
      80 for509 against8 abstentions108 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    5. 10 Apr 2024Rejected
      On amendment 345 — paragraph 1 — article 81
      Official label: Article 81, § 1 - Am 345 · what was voted ↗
      91 for490 against9 abstentions115 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

  2. 10 Apr 2024Rejected
    On amendment 346 — paragraph 1 — article 82 — subparagraph 1
    Official label: Article 82, § 1, alinéa 1 - Am 346 · what was voted ↗
    53 for532 against14 abstentions106 did not vote
    For
    Against
    Abst.

    Click a group to see each Member’s position.

  3. 10 Apr 2024Rejected
    On amendment 339 — recital 11
    Official label: Considérant 11 - Am 339 · what was voted ↗
    112 for464 against6 abstentions123 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 ↗
    495 for57 against45 abstentions108 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)

Official amendment documents

PE754.916 ↗PE754.917 ↗PE756.261 ↗PE757.082 ↗PE757.083 ↗PE757.084 ↗

Connections

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See these connections as a navigable graph — and walk from there to anything else.

Explore the graph
Full record

Members who amended this procedure

64 Members · by amendment count
1🇪🇸
Nicolás GONZÁLEZ CASARES
Socialists & Democrats · Spain
448
2🇩🇰
Margrete AUKEN
Greens / EFA · Denmark
236(236 solo)
3🇪🇸
Laura BALLARÍN CEREZA
Socialists & Democrats · Spain
232
4🇩🇪
Tiemo WÖLKEN
Socialists & Democrats · Germany
222
5🇪🇸
Susana SOLÍS PÉREZ
European People's Party (EPP) · Spain
200(24 solo)
6🇩🇰
Pernille WEISS
European People's Party (EPP) · Denmark
196(196 solo)
7🇪🇸
Margarita DE LA PISA CARRIÓN
Patriots for Europe · Spain
194(188 solo)
8🇸🇮
Klemen GROŠELJ
Renew Europe · Slovenia
123
9🇫🇮
Ville NIINISTÖ
Greens / EFA · Finland
109(109 solo)
10🇷🇴
Cristian-Silviu BUŞOI
European People's Party (EPP) · Romania
100(100 solo)
11🇫🇷
Catherine AMALRIC
Renew Europe · France
75(7 solo)
12🇮🇪
Billy KELLEHER
Renew Europe · Ireland
67(2 solo)
13🇪🇸
Pilar DEL CASTILLO VERA
European People's Party (EPP) · Spain
60(60 solo)
14🇮🇹
Pietro FIOCCHI
European Conservatives & Reformists · Italy
55(19 solo)
15🇨🇿
Ondřej KNOTEK
Patriots for Europe · Czechia
42
16🇫🇷
Max ORVILLE
Renew Europe · France
40
17🇵🇱
Joanna KOPCIŃSKA
European Conservatives & Reformists · Poland
38(26 solo)
18🇧🇪
Frédérique RIES
Renew Europe · Belgium
38
19🇭🇷
Tomislav SOKOL
European People's Party (EPP) · Croatia
37(17 solo)
20🇮🇹
Elisabetta DE BLASIS
European Conservatives & Reformists · Italy
36
21🇫🇷
Nathalie COLIN-OESTERLÉ
European People's Party (EPP) · France
35(12 solo)
22🇨🇿
Kateřina KONEČNÁ
Non-attached · Czechia
35(35 solo)
23🇩🇰
Erik POULSEN
Renew Europe · Denmark
35
24🇷🇴
Marian-Jean MARINESCU
European People's Party (EPP) · Romania
33(33 solo)
25🇮🇹
Patrizia TOIA
Socialists & Democrats · Italy
33

The amendments, in full text

2,180 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.