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Procedure

European Medicines Agency

2020/0321(COD)·9th term·ENVI / ITRE·COD - Ordinary legislative procedure (ex-codecision procedure)·CompletedProcedure completed
Subjects: Medicine, diseases · Pharmaceutical products and industry · Health legislation and policy · Agencies and bodies of the EU
Rapporteur (the Member appointed to lead Parliament's work on this text): GONZÁLEZ CASARES Nicolás (S&D)
Summary

This dossier concerns the European Medicines Agency. Amendments revise recitals on the COVID-19 pandemic and shortages of medicinal products and medical devices, the monitoring of shortages and supply, the Agency's executive steering groups and an Emergency Task Force on clinical trials, vaccines and treatments, the role of the Medical Device Coordination Group and expert panels, and conformity assessment derogations.

Procedure timeline

  1. Committee amendments tabled
    26 Mar 2021 – 28 Apr 2021
  2. Plenary vote — Passed
    8 Jul 2021 · On the Commission proposal (the draft law)
  3. Plenary vote — Passed
    19 Jan 2022 · On the provisional agreement negotiated with the Council (the trilogue deal) — amendment 156
  4. Procedure completed
884
Amendments
distinct, in window
64
Members
tabled at least one
2
Committee(s)
26 Mar 2021 – 28 Apr 2021
Dates

Plenary votes

18 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 →

Where each group stood at the decisive votes

GroupShift
EPPFor100%For100%consistent
S&DFor100%For100%consistent
RenewFor100%For100%consistent
Greens/EFAFor100%For100%consistent
ECRAbstained75%For86%Abstained → For
The LeftFor100%For100%consistent
IDAbstained45%For67%Abstained → For
Non-attachedFor78%For79%consistent

Milestones are the votes that adopt or reject text (not every amendment vote) — the percentage is the share of the group’s Members behind that position. Click a column heading to open the vote below.

  1. Show the 15 earlier votes
    1. 7 Jul 2021Passedoutcome from totals
      On amendment 97
      Official label: Am 97 · what was voted ↗
      434 for202 against57 abstentions12 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    2. 7 Jul 2021Failedoutcome from totals
      On amendment 155
      Official label: Am 155 · what was voted ↗
      274 for411 against8 abstentions12 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    3. 7 Jul 2021Failedoutcome from totals
      On amendment 153
      Official label: Am 153 · what was voted ↗
      302 for371 against20 abstentions12 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    4. 7 Jul 2021Passedoutcome from totals
      On amendment 4
      Official label: Am 4-73, 75-96, 98-125, 127-143, 145-152 · what was voted ↗
      585 for22 against86 abstentions12 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    5. 7 Jul 2021Passedoutcome from totals
      On amendment 74 (part 1 of a split vote)
      Official label: Am 74/1 · what was voted ↗
      630 for25 against38 abstentions12 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    6. 7 Jul 2021Passedoutcome from totals
      On amendment 74 (part 2 of a split vote)
      Official label: Am 74/2 · what was voted ↗
      425 for260 against8 abstentions12 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    7. 7 Jul 2021Passedoutcome from totals
      On amendment 126 (part 1 of a split vote)
      Official label: Am 126/1 · what was voted ↗
      631 for25 against37 abstentions12 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    8. 7 Jul 2021Passedoutcome from totals
      On amendment 126 (part 2 of a split vote)
      Official label: Am 126/2 · what was voted ↗
      424 for262 against7 abstentions12 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    9. 7 Jul 2021Passedoutcome from totals
      On amendment 144
      Official label: Am 144 · what was voted ↗
      560 for121 against12 abstentions12 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    10. 7 Jul 2021Passedoutcome from totals
      On amendment 1 (part 1 of a split vote)
      Official label: Am 1/1 · what was voted ↗
      655 for17 against21 abstentions12 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    11. 7 Jul 2021Passedoutcome from totals
      On amendment 1 (part 2 of a split vote)
      Official label: Am 1/2 · what was voted ↗
      579 for71 against43 abstentions12 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    12. 7 Jul 2021Passedoutcome from totals
      On amendment 2 (part 1 of a split vote)
      Official label: Am 2/1 · what was voted ↗
      656 for7 against30 abstentions12 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    13. 7 Jul 2021Passedoutcome from totals
      On amendment 2 (part 2 of a split vote)
      Official label: Am 2/2 · what was voted ↗
      548 for85 against60 abstentions12 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    14. 7 Jul 2021Passedoutcome from totals
      On amendment 3 (part 1 of a split vote)
      Official label: Am 3/1 · what was voted ↗
      668 for20 against5 abstentions12 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

    15. 7 Jul 2021Passedoutcome from totals
      On amendment 3 (part 2 of a split vote)
      Official label: Am 3/2 · what was voted ↗
      538 for94 against61 abstentions12 did not vote
      For
      Against
      Abst.

      Click a group to see each Member’s position.

  2. 8 Jul 2021Passedoutcome from totals
    On a procedural vote to send the text back to committee, under Parliament's rules
    Official label: Renvoi (article 59, paragraphe 4, du règlement) · what was voted ↗
    665 for20 against11 abstentions9 did not vote
    For
    Against
    Abst.

    Click a group to see each Member’s position.

  3. 8 Jul 2021Main votePassedoutcome from totals
    On the Commission proposal (the draft law)
    Official label: Proposition de la Commission · what was voted ↗
    587 for28 against81 abstentions9 did not vote
    For
    Against
    Abst.

    Click a group to see each Member’s position.

  4. 19 Jan 2022Main votePassedoutcome from totals
    On the provisional agreement negotiated with the Council (the trilogue deal) — amendment 156
    Official label: Accord provisoire - Am 156 · what was voted ↗
    655 for31 against8 abstentions11 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

Official amendment documents

PE691.131 ↗PE691.443 ↗

Connections

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Full record

Members who amended this procedure

64 Members · by amendment count
1🇪🇸
Margarita DE LA PISA CARRIÓN
Patriots for Europe · Spain
97(88 solo)
2🇫🇷
Joëlle MÉLIN
Identity & Democracy · France
86(82 solo)
3🇱🇺
Tilly METZ
Greens / EFA · Luxembourg
81(81 solo)
4🇩🇪
Jutta PAULUS
Greens / EFA · Germany
73(73 solo)
5🇮🇹
Aldo PATRICIELLO
Patriots for Europe · Italy
64(37 solo)
6🇪🇸
Antoni COMÍN I OLIVERES
Non-attached · Spain
60(60 solo)
7🇨🇿
Kateřina KONEČNÁ
Non-attached · Czechia
47(47 solo)
8🇧🇪
Frédérique RIES
Renew Europe · Belgium
45
9🇫🇷
Véronique TRILLET-LENOIR
Renew Europe · France
45
10🇷🇴
Nicolae ȘTEFĂNUȚĂ
Greens / EFA · Romania
45
11🇪🇸
Susana SOLÍS PÉREZ
European People's Party (EPP) · Spain
45
12🇷🇴
Cristian-Silviu BUŞOI
European People's Party (EPP) · Romania
44
13🇩🇪
Andreas GLÜCK
Renew Europe · Germany
42
14🇸🇰
Martin HOJSÍK
Renew Europe · Slovakia
42
15🇪🇸
María Soraya RODRÍGUEZ RAMOS
Renew Europe · Spain
42
16🇫🇷
Nathalie COLIN-OESTERLÉ
European People's Party (EPP) · France
41(41 solo)
17🇮🇹
Pietro FIOCCHI
European Conservatives & Reformists · Italy
30(30 solo)
18🇮🇹
Danilo Oscar LANCINI
Identity & Democracy · Italy
28(25 solo)
19🇷🇴
Ioan-Rareş BOGDAN
European People's Party (EPP) · Romania
27
20🇵🇹
Maria da Graça CARVALHO
European People's Party (EPP) · Portugal
27
21🇮🇹
Massimiliano SALINI
European People's Party (EPP) · Italy
26
22🇧🇬
Ivo HRISTOV
Socialists & Democrats · Bulgaria
26
23🇪🇸
Nicolás GONZÁLEZ CASARES
Socialists & Democrats · Spain
26
24🇵🇹
Maria-Manuel LEITÃO-MARQUES
Socialists & Democrats · Portugal
26
25🇪🇸
Lina GÁLVEZ
Socialists & Democrats · Spain
26

The amendments, in full text

884 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.