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

European Parliament procedure 2023/0131(COD) (COD - Ordinary legislative procedure (ex-codecision procedure), 9th term, committee ENVI / ITRE). Stage: Awaiting Council's 1st reading position. 2,004 committee amendments tabled by 58 Members between 2023-11-21 and 2023-11-30.

## What the amendments focus on

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.

## Most active Members on this file

| Member | Country | Group | Amendments | Markdown |
|---|---|---|---|---|
| Susana SOLÍS PÉREZ | Spain | PPE | 271 | https://amendeu.com/md/meps/197784.md |
| Catherine AMALRIC | France | RE | 213 | https://amendeu.com/md/meps/247122.md |
| Tilly METZ | Luxembourg | Verts/ALE | 194 | https://amendeu.com/md/meps/193292.md |
| Max ORVILLE | France | RE | 175 | https://amendeu.com/md/meps/234344.md |
| Billy KELLEHER | Ireland | RE | 160 | https://amendeu.com/md/meps/197818.md |
| Frédérique RIES | Belgium | RE | 146 | https://amendeu.com/md/meps/4253.md |
| Andrey SLABAKOV | Bulgaria | ECR | 145 | https://amendeu.com/md/meps/197849.md |
| Tomislav SOKOL | Croatia | PPE | 144 | https://amendeu.com/md/meps/197417.md |
| Pernille WEISS | Denmark | PPE | 120 | https://amendeu.com/md/meps/197515.md |
| Klemen GROŠELJ | Slovenia | RE | 120 | https://amendeu.com/md/meps/197452.md |
| Laura BALLARÍN CEREZA | Spain | S&D | 89 | https://amendeu.com/md/meps/247735.md |
| Nicolás GONZÁLEZ CASARES | Spain | S&D | 87 | https://amendeu.com/md/meps/197718.md |
| Erik POULSEN | Denmark | RE | 86 | https://amendeu.com/md/meps/239972.md |
| Margarita DE LA PISA CARRIÓN | Spain | PfE | 85 | https://amendeu.com/md/meps/204414.md |
| Maria Angela DANZÌ | Italy | NI | 73 | https://amendeu.com/md/meps/239258.md |

## Official source documents

- PE756.131: https://www.europarl.europa.eu/doceo/document/ENVI-AM-756131_EN.pdf
- PE756.132: https://www.europarl.europa.eu/doceo/document/ENVI-AM-756132_EN.pdf
- PE756.133: https://www.europarl.europa.eu/doceo/document/ENVI-AM-756133_EN.pdf
- PE756.134: https://www.europarl.europa.eu/doceo/document/ENVI-AM-756134_EN.pdf
- PE756.135: https://www.europarl.europa.eu/doceo/document/ENVI-AM-756135_EN.pdf
- PE756.136: https://www.europarl.europa.eu/doceo/document/ENVI-AM-756136_EN.pdf

Full amendment texts, votes and exports: https://amendeu.com/dossiers/2023-0131-COD · machine-readable: https://amendeu.com/data/dossiers/2023-0131-COD.json

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Data refreshed: 2026-07-27. Human-readable version: https://amendeu.com/dossiers/2023-0131-COD
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