# Medicinal products for human use: fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities

European Parliament procedure 2013/0222(COD) (COD - Ordinary legislative procedure (ex-codecision procedure), 7th term, committee ENVI). Stage: Procedure completed. 98 committee amendments tabled by 14 Members between 2013-11-11 and 2013-11-11.

## What the amendments focus on

The dossier concerns fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities relating to medicinal products for human use. Amendments address fees for periodic safety update reports, post-authorisation safety studies and referral procedures, the chargeable unit, remuneration of rapporteurs, avoiding double charging by Member States, and reductions or exemptions for SMEs, homeopathic and herbal medicinal products and small target groups.

## Most active Members on this file

| Member | Country | Group | Amendments | Markdown |
|---|---|---|---|---|
| Michèle RIVASI | France | Verts/ALE | 18 | https://amendeu.com/md/meps/96743.md |
| Dagmar ROTH-BEHRENDT | Germany | S&D | 16 | https://amendeu.com/md/meps/1183.md |
| Antonyia PARVANOVA | Bulgaria | ALDE | 12 | https://amendeu.com/md/meps/34234.md |
| Peter LIESE | Germany | PPE | 12 | https://amendeu.com/md/meps/1927.md |
| Françoise GROSSETÊTE | France | PPE | 11 | https://amendeu.com/md/meps/2025.md |
| Marina YANNAKOUDAKIS | United Kingdom | ECR | 11 | https://amendeu.com/md/meps/96944.md |
| Pilar AYUSO | Spain | PPE | 10 | https://amendeu.com/md/meps/4319.md |
| Thomas ULMER | Germany | PPE | 7 | https://amendeu.com/md/meps/28221.md |
| Ingeborg GRÄSSLE | Germany | PPE | 7 | https://amendeu.com/md/meps/28220.md |
| Georgios KOUMOUTSAKOS | Greece | PPE | 5 | https://amendeu.com/md/meps/97011.md |
| Spyros DANELLIS | Greece | S&D | 5 | https://amendeu.com/md/meps/99325.md |
| Alda SOUSA | Portugal | GUE/NGL | 5 | https://amendeu.com/md/meps/113487.md |
| Linda McAVAN | United Kingdom | S&D | 4 | https://amendeu.com/md/meps/2327.md |
| Alojz PETERLE | Slovenia | PPE | 2 | https://amendeu.com/md/meps/23693.md |

## Official source documents

- PE523.004: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-523.004+01+DOC+PDF+V0//EN&language=EN

Full amendment texts, votes and exports: https://amendeu.com/dossiers/2013-0222-COD · machine-readable: https://amendeu.com/data/dossiers/2013-0222-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/2013-0222-COD
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