# Medicinal products for human use: pharmacovigilance of products

European Parliament procedure 2008/0260(COD) (COD - Ordinary legislative procedure (ex-codecision procedure), 7th term, committee ENVI / IMCO / ITRE). Stage: Procedure completed. 331 committee amendments tabled by 37 Members between 2010-02-03 and 2010-03-15.

## What the amendments focus on

This dossier concerns pharmacovigilance of medicinal products for human use. Amendments revise recitals defining 'medication error' and 'adverse reaction', the marketing authorisation holder's pharmacovigilance system and master file, post-authorisation safety studies, information in the summary of product characteristics and package leaflet, reporting of suspected adverse reactions by Member States and health professionals, safety web-portals, and pharmaceutical residues in water.

## Most active Members on this file

| Member | Country | Group | Amendments | Markdown |
|---|---|---|---|---|
| Michèle RIVASI | France | Verts/ALE | 45 | https://amendeu.com/md/meps/96743.md |
| Philippe JUVIN | France | PPE | 36 | https://amendeu.com/md/meps/96884.md |
| Bernadette VERGNAUD | France | S&D | 26 | https://amendeu.com/md/meps/28177.md |
| Thomas ULMER | Germany | PPE | 24 | https://amendeu.com/md/meps/28221.md |
| Pilar AYUSO | Spain | PPE | 21 | https://amendeu.com/md/meps/4319.md |
| Antonyia PARVANOVA | Bulgaria | ALDE | 20 | https://amendeu.com/md/meps/34234.md |
| Anne DELVAUX | Belgium | PPE | 19 | https://amendeu.com/md/meps/96914.md |
| Peter LIESE | Germany | PPE | 18 | https://amendeu.com/md/meps/1927.md |
| Françoise GROSSETÊTE | France | PPE | 16 | https://amendeu.com/md/meps/2025.md |
| Jiří MAŠTÁLKA | Czechia | GUE/NGL | 14 | https://amendeu.com/md/meps/23704.md |
| Anja WEISGERBER | Germany | PPE | 11 | https://amendeu.com/md/meps/28227.md |
| Corinne LEPAGE | France | ALDE | 11 | https://amendeu.com/md/meps/97076.md |
| Jorgo CHATZIMARKAKIS | Germany | ALDE | 10 | https://amendeu.com/md/meps/28243.md |
| António Fernando CORREIA DE CAMPOS | France | S&D | 9 | https://amendeu.com/md/meps/96975.md |
| Horst SCHNELLHARDT | Germany | PPE | 8 | https://amendeu.com/md/meps/1930.md |

## Official source documents

- PE438.412: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.412+02+DOC+PDF+V0//EN&language=EN
- PE438.448: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.448+01+DOC+PDF+V0//EN&language=EN
- PE438.514: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.514+01+DOC+PDF+V0//EN&language=EN

Full amendment texts, votes and exports: https://amendeu.com/dossiers/2008-0260-COD · machine-readable: https://amendeu.com/data/dossiers/2008-0260-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/2008-0260-COD
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