Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 3: Difference between revisions
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Revision as of 15:06, 29 June 2026
| Document information | |
|---|---|
| Reference | GBR Directive 2001/20/EC 04-Apr-2001 |
| Validity area | GBR |
| Scope(s) | HM |
| Document name | Directive 2001/20/EC |
| Version / Revision | 04-Apr-2001 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL - of 4 April 2001
on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use The European Directive (2001/20/EC) no longer applies in the UK. The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations amend the Medicines for Human Use (Clinical Trials) Regulations 2004 to enable the MHRA to operate as a regulator outside the EU. |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Scope | HM |
| Document part | Article 3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Insurance requirement for clinical trial participation |
Content
Protection of clinical trial subjects […] 2. A clinical trial may be undertaken only if, in particular: […] (f) provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor.
