Authorisation and supervision of medicinal products for human use and governing rules for the European Medicines Agency
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
- Committee amendments tabled21 Nov 2023 – 30 Nov 2023
- Plenary vote — Adopted10 Apr 2024 · On the Commission proposal (the draft law)
- In progress — not yet concluded
Plenary votes
6 roll-call votesIn 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 →
Show the 3 earlier votes
- 10 Apr 2024RejectedOn amendment 373 — paragraph 3 — article 33Official label: Article 33, § 3 - Am 373 · what was voted ↗129 for459 against1 abstentions116 did not voteForAgainstAbst.
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- 10 Apr 2024RejectedOn amendment 379 — article 40Official label: Après l'article 40 - Am 379 · what was voted ↗156 for334 against98 abstentions117 did not voteForAgainstAbst.
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- 10 Apr 2024RejectedOn amendment 378 — text to be inserted before paragraph 1 — article 134Official label: Article 134, avant le § 1 - Am 378 · what was voted ↗96 for450 against36 abstentions123 did not voteForAgainstAbst.
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- 10 Apr 2024RejectedOn amendment 377 — text to be inserted after recital 3Official label: Après le considérant 3 - Am 377 · what was voted ↗73 for504 against15 abstentions113 did not voteForAgainstAbst.
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- 10 Apr 2024RejectedOn amendment 368 — text to be inserted after recital 5Official label: Après le considérant 5 - Am 368 · what was voted ↗62 for443 against59 abstentions141 did not voteForAgainstAbst.
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- 10 Apr 2024Main voteAdoptedOn the Commission proposal (the draft law)Official label: Proposition de la Commission · what was voted ↗488 for67 against34 abstentions116 did not voteForAgainstAbst.
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Vote data: HowTheyVote.eu (ODbL, attribution) / European Parliament · roll-call votes only
How groups usually vote on similar files
Based on 2,388 past all main roll-call votes, Jul 2019 → 2026-07-04.
Statistical baseline from past roll-call votes; not a forecast. · roll-call votes only
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Official amendment documents
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Explore the graphMembers who amended this procedure
58 Members · by amendment countThe amendments, in full text
2,004 amendmentsEvery amendment as tabled — original text, proposed change and justification, with a link to the official PDF.