# Medicinal products for human use: pharmacovigilance of products

European Parliament procedure 2008/0257(COD) (COD - Ordinary legislative procedure (ex-codecision procedure), 7th term, committee ENVI / IMCO / ITRE). Stage: Procedure completed. 118 committee amendments tabled by 32 Members between 2010-02-05 and 2010-03-01.

## What the amendments focus on

This dossier concerns pharmacovigilance of medicinal products for human use. Amendments address the Eudravigilance database as a single point of receipt, a medicines safety web-portal, creation of a Pharmacovigilance Risk Assessment Committee, post-authorisation safety studies, reporting of suspected adverse reactions by health professionals and patients, traceability of biological medicinal products, funding, and monitoring environmental effects of pharmaceutical residues.

## Most active Members on this file

| Member | Country | Group | Amendments | Markdown |
|---|---|---|---|---|
| Bernadette VERGNAUD | France | S&D | 16 | https://amendeu.com/md/meps/28177.md |
| Michèle RIVASI | France | Verts/ALE | 14 | https://amendeu.com/md/meps/96743.md |
| Jiří MAŠTÁLKA | Czechia | GUE/NGL | 9 | https://amendeu.com/md/meps/23704.md |
| Antonyia PARVANOVA | Bulgaria | ALDE | 9 | https://amendeu.com/md/meps/34234.md |
| Anja WEISGERBER | Germany | PPE | 8 | https://amendeu.com/md/meps/28227.md |
| Pilar AYUSO | Spain | PPE | 8 | https://amendeu.com/md/meps/4319.md |
| Philippe JUVIN | France | PPE | 6 | https://amendeu.com/md/meps/96884.md |
| Cristina GUTIÉRREZ-CORTINES | Spain | PPE | 6 | https://amendeu.com/md/meps/4326.md |
| Ashley FOX | United Kingdom | ECR | 6 | https://amendeu.com/md/meps/96957.md |
| Anne DELVAUX | Belgium | PPE | 5 | https://amendeu.com/md/meps/96914.md |
| Elena Oana ANTONESCU | Romania | PPE | 4 | https://amendeu.com/md/meps/96702.md |
| Dagmar ROTH-BEHRENDT | Germany | S&D | 4 | https://amendeu.com/md/meps/1183.md |
| Marian-Jean MARINESCU | Romania | PPE | 3 | https://amendeu.com/md/meps/33982.md |
| Patrizia TOIA | Italy | S&D | 3 | https://amendeu.com/md/meps/28340.md |
| Åsa WESTLUND | Sweden | S&D | 2 | https://amendeu.com/md/meps/28130.md |

## Official source documents

- PE438.413: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN
- PE438.462: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN
- PE438.505: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.505+02+DOC+PDF+V0//EN&language=EN

Full amendment texts, votes and exports: https://amendeu.com/dossiers/2008-0257-COD · machine-readable: https://amendeu.com/data/dossiers/2008-0257-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/2008-0257-COD
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