# Medicinal products for human and veterinary use: marketing authorisations

European Parliament procedure 2008/0045(COD) (COD - Ordinary legislative procedure (ex-codecision procedure), 6th term, committee AGRI / ENVI). Stage: Procedure completed. 24 committee amendments tabled by 14 Members between 2008-07-18 and 2008-08-26.

## What the amendments focus on

Legislative proposal on marketing authorisations for medicinal products for human and veterinary use. The amendments concern the transposition deadline and recitals on legal consistency and predictability for variations to marketing authorisations, with several provisions deleted, and the Commission adopting arrangements for examining variations to authorisations granted through national, mutual recognition, centralised or decentralised procedures.

## Most active Members on this file

| Member | Country | Group | Amendments | Markdown |
|---|---|---|---|---|
| Françoise GROSSETÊTE | France | PPE | 11 | https://amendeu.com/md/meps/2025.md |
| Dagmar ROTH-BEHRENDT | Germany | S&D | 3 | https://amendeu.com/md/meps/1183.md |
| Thomas ULMER | Germany | PPE | 2 | https://amendeu.com/md/meps/28221.md |
| Astrid LULLING | Luxembourg | PPE | 1 | https://amendeu.com/md/meps/1186.md |
| Avril DOYLE | Ireland | PPE-DE | 1 | https://amendeu.com/md/meps/4382.md |
| Donato Tommaso VERALDI | Italy | ALDE | 1 | https://amendeu.com/md/meps/36394.md |
| Iles BRAGHETTO | Italy | PPE-DE | 1 | https://amendeu.com/md/meps/34174.md |
| Jerzy BUZEK | Poland | PPE | 1 | https://amendeu.com/md/meps/28269.md |
| Bogusław SONIK | Poland | PPE | 1 | https://amendeu.com/md/meps/28299.md |
| Edite ESTRELA | Portugal | S&D | 1 | https://amendeu.com/md/meps/28310.md |
| Anne FERREIRA | France | PSE | 1 | https://amendeu.com/md/meps/5735.md |
| David MARTIN | United Kingdom | S&D | 1 | https://amendeu.com/md/meps/1403.md |
| Riitta MYLLER | Finland | PSE | 1 | https://amendeu.com/md/meps/2062.md |
| Carl SCHLYTER | Sweden | Verts/ALE | 1 | https://amendeu.com/md/meps/28139.md |

## Official source documents

- PE409.694: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-409.694+01+DOC+PDF+V0//EN&language=EN
- PE409.740: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-409.740+01+DOC+PDF+V0//EN&language=EN

Full amendment texts, votes and exports: https://amendeu.com/dossiers/2008-0045-COD · machine-readable: https://amendeu.com/data/dossiers/2008-0045-COD.json

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Data refreshed: 2026-07-27. Human-readable version: https://amendeu.com/dossiers/2008-0045-COD
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