# Medicinal products for human use

European Parliament procedure 2023/0132(COD) (COD - Ordinary legislative procedure (ex-codecision procedure), 9th term, committee ENVI / ITRE). Stage: Awaiting Council's 1st reading position. 1,844 committee amendments tabled by 64 Members between 2023-11-21 and 2023-12-01.

## What the amendments focus on

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.

## Most active Members on this file

| Member | Country | Group | Amendments | Markdown |
|---|---|---|---|---|
| Nicolás GONZÁLEZ CASARES | Spain | S&D | 448 | https://amendeu.com/md/meps/197718.md |
| Margrete AUKEN | Denmark | Verts/ALE | 236 | https://amendeu.com/md/meps/28161.md |
| Laura BALLARÍN CEREZA | Spain | S&D | 232 | https://amendeu.com/md/meps/247735.md |
| Tiemo WÖLKEN | Germany | S&D | 222 | https://amendeu.com/md/meps/185619.md |
| Susana SOLÍS PÉREZ | Spain | PPE | 200 | https://amendeu.com/md/meps/197784.md |
| Pernille WEISS | Denmark | PPE | 196 | https://amendeu.com/md/meps/197515.md |
| Margarita DE LA PISA CARRIÓN | Spain | PfE | 194 | https://amendeu.com/md/meps/204414.md |
| Klemen GROŠELJ | Slovenia | RE | 123 | https://amendeu.com/md/meps/197452.md |
| Ville NIINISTÖ | Finland | Verts/ALE | 109 | https://amendeu.com/md/meps/197802.md |
| Cristian-Silviu BUŞOI | Romania | PPE | 100 | https://amendeu.com/md/meps/38420.md |
| Catherine AMALRIC | France | RE | 75 | https://amendeu.com/md/meps/247122.md |
| Billy KELLEHER | Ireland | RE | 67 | https://amendeu.com/md/meps/197818.md |
| Pilar DEL CASTILLO VERA | Spain | PPE | 60 | https://amendeu.com/md/meps/28390.md |
| Pietro FIOCCHI | Italy | ECR | 55 | https://amendeu.com/md/meps/197607.md |
| Ondřej KNOTEK | Czechia | PfE | 42 | https://amendeu.com/md/meps/197528.md |

## Official source documents

- PE754.916: https://www.europarl.europa.eu/doceo/document/ENVI-AM-754916_EN.pdf
- PE754.917: https://www.europarl.europa.eu/doceo/document/ENVI-AM-754917_EN.pdf
- PE756.261: https://www.europarl.europa.eu/doceo/document/ENVI-AM-756261_EN.pdf
- PE757.082: https://www.europarl.europa.eu/doceo/document/ITRE-AM-757082_EN.pdf
- PE757.083: https://www.europarl.europa.eu/doceo/document/ITRE-AM-757083_EN.pdf
- PE757.084: https://www.europarl.europa.eu/doceo/document/ITRE-AM-757084_EN.pdf

Full amendment texts, votes and exports: https://amendeu.com/dossiers/2023-0132-COD · machine-readable: https://amendeu.com/data/dossiers/2023-0132-COD.json

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Source: AmendEU (amendeu.com), built from Parltrack (ODbL), European Parliament Open Data ((c) European Union) and official Parliament documents. Aggregates CC BY 4.0.
Data refreshed: 2026-07-27. Human-readable version: https://amendeu.com/dossiers/2023-0132-COD
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