Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 12.: Difference between revisions
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| Â | | [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00035-Man-odu|Manufacturing]], [[Glossary:TAG-00011-Inv-tud|Investigational drug (IMP)]], [[Glossary:TAG-00132-Goo-rst|Good manufacturing practice]], [[Glossary:TAG-00095-Sto-ung|IMP storage]] | ||
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Revision as of 17:29, 15 July 2026
| Document information | |
|---|---|
| Reference | GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 |
| Validity area | GBR |
| Scope(s) | HM |
| Document name | The Medicines for Human Use (Clinical Trials) Regulations 2004 |
| Version / Revision | 01-May-2004 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | The Medicines for Human Use (Clinical Trials) Regulations 2004 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 3 — Unit 3.4.2 |
| Scope | HM |
| Document part | Schedule 1
Part 2 12. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Good clinical practice, Manufacturing, Investigational drug (IMP), Good manufacturing practice, IMP storage |
| Comment | GCP principles: responsibilities for IMP management |
Content
CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS Principles based on International Conference on Harmonisation GCP Guideline [...] 12. Investigational medicinal products used in the trial shall be— (a)manufactured or imported, and handled and stored, in accordance with the principles and guidelines of good manufacturing practice, and (b)used in accordance with the approved protocol.
