Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 7 Part 2 2.: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 | ||
| | |module=3 | ||
| | |unit=3.4.2 | ||
|scope=HM | |||
|doc_part=Schedule 7 | |||
Part 2 | Part 2 | ||
2. | 2. | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
|tags=TAG-00035-Man-odu ++ TAG-00011-Inv-tud ++ TAG-00132-Goo-rst ++ TAG-00057-Com-deR | |||
|tags_display=[[Glossary:TAG-00035-Man-odu|Manufacturing]], [[Glossary:TAG-00011-Inv-tud|Investigational drug (IMP)]], [[Glossary:TAG-00132-Goo-rst|Good manufacturing practice]], [[Glossary:TAG-00057-Com-deR|Competent authority]] | |||
Β | |comment=Provisions for manufacturing or assembly authorisation of IMPs | ||
|content=PROVISIONS WHICH MAY BE INCORPORATED IN AN AUTHORISATION RELATING TO THE MANUFACTURE OR ASSEMBLY OF INVESTIGATIONAL MEDICINAL PRODUCTS | |||
Β | |||
| | |||
| | |||
Β | |||
= | |||
PROVISIONS WHICH MAY BE INCORPORATED IN AN AUTHORISATION RELATING TO THE MANUFACTURE OR ASSEMBLY OF INVESTIGATIONAL MEDICINAL PRODUCTS | |||
[...] | [...] | ||
2.Β The holder of the authorisation shallβ | 2.Β The holder of the authorisation shallβ | ||
| Line 51: | Line 19: | ||
(b)not use for such purposes premises other than those specified in the authorisation or which may be approved from time to time by the licensing authority; and | (b)not use for such purposes premises other than those specified in the authorisation or which may be approved from time to time by the licensing authority; and | ||
(c)ensure that any arrangements he makes with a person for the storage and distribution of the investigational medicinal products are adequate to maintain the quality of those products. | (c)ensure that any arrangements he makes with a person for the storage and distribution of the investigational medicinal products are adequate to maintain the quality of those products. | ||
}} | |||
Revision as of 12:55, 16 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 β Unit 3.4.2 |
| Scope | HM |
| Document part | Schedule 7
Part 2 2. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Manufacturing, Investigational drug (IMP), Good manufacturing practice, Competent authority |
Content
PROVISIONS WHICH MAY BE INCORPORATED IN AN AUTHORISATION RELATING TO THE MANUFACTURE OR ASSEMBLY OF INVESTIGATIONAL MEDICINAL PRODUCTS [...] 2. The holder of the authorisation shallβ (a)provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of the investigational medicinal products which he handles, stores or distributes under his authorisation as are necessary to maintain the quality of the investigational medicinal products; (b)not use for such purposes premises other than those specified in the authorisation or which may be approved from time to time by the licensing authority; and (c)ensure that any arrangements he makes with a person for the storage and distribution of the investigational medicinal products are adequate to maintain the quality of those products.
