# Clinical trials on medicinal products for human use

European Parliament procedure 2012/0192(COD) (COD - Ordinary legislative procedure (ex-codecision procedure), 7th term, committee ENVI / IMCO / ITRE / LIBE). Stage: Procedure completed. 841 committee amendments tabled by 59 Members between 2013-02-01 and 2013-03-20.

## What the amendments focus on

Regulation on clinical trials on medicinal products for human use. The amendments rework the definition of a clinical trial and of low-risk, low-intervention and medium-risk trials, the conditions on whether investigational medicinal products are authorised for marketing, the assessment carried out by each Member State, the protection of subjects and informed consent, and the requirement for prior authorisation including review by an ethics committee.

## Most active Members on this file

| Member | Country | Group | Amendments | Markdown |
|---|---|---|---|---|
| Philippe JUVIN | France | PPE | 226 | https://amendeu.com/md/meps/96884.md |
| António Fernando CORREIA DE CAMPOS | France | S&D | 91 | https://amendeu.com/md/meps/96975.md |
| Margrete AUKEN | Denmark | Verts/ALE | 76 | https://amendeu.com/md/meps/28161.md |
| Roberta ANGELILLI | Italy | PPE | 53 | https://amendeu.com/md/meps/1941.md |
| Anna ROSBACH | Denmark | ECR | 51 | https://amendeu.com/md/meps/96664.md |
| Alda SOUSA | Portugal | GUE/NGL | 42 | https://amendeu.com/md/meps/113487.md |
| Richard SEEBER | Austria | PPE | 39 | https://amendeu.com/md/meps/28252.md |
| Thomas ULMER | Germany | PPE | 38 | https://amendeu.com/md/meps/28221.md |
| Elena Oana ANTONESCU | Romania | PPE | 37 | https://amendeu.com/md/meps/96702.md |
| Edite ESTRELA | Portugal | S&D | 33 | https://amendeu.com/md/meps/28310.md |
| Peter LIESE | Germany | PPE | 32 | https://amendeu.com/md/meps/1927.md |
| Christel SCHALDEMOSE | Denmark | S&D | 29 | https://amendeu.com/md/meps/37312.md |
| Anne DELVAUX | Belgium | PPE | 29 | https://amendeu.com/md/meps/96914.md |
| Alojz PETERLE | Slovenia | PPE | 29 | https://amendeu.com/md/meps/23693.md |
| Miroslav MIKOLÁŠIK | Slovakia | PPE | 29 | https://amendeu.com/md/meps/28178.md |

## Official source documents

- PE504.308: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-504.308+01+DOC+PDF+V0//EN&language=EN
- PE506.087: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.087+01+DOC+PDF+V0//EN&language=EN
- PE506.158: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.158+01+DOC+PDF+V0//EN&language=EN
- PE506.159: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.159+02+DOC+PDF+V0//EN&language=EN
- PE506.160: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.160+02+DOC+PDF+V0//EN&language=EN
- PE506.161: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-506.161+01+DOC+PDF+V0//EN&language=EN

Full amendment texts, votes and exports: https://amendeu.com/dossiers/2012-0192-COD · machine-readable: https://amendeu.com/data/dossiers/2012-0192-COD.json

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Data refreshed: 2026-07-27. Human-readable version: https://amendeu.com/dossiers/2012-0192-COD
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