Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 investigational medicinal product: 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=Article 2 | |||
investigational medicinal product | investigational medicinal product | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
|tags=TAG-00011-Inv-tud ++ TAG-00244-Def-ini ++ TAG-00277-Pla-par | |||
|tags_display=[[Glossary:TAG-00011-Inv-tud|Investigational drug (IMP)]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00277-Pla-par|Placebo]] | |||
|comment=Definition of investigational medicinal product | |||
|content=“investigational medicinal product” means a pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical trial, and includes a medicinal product which has a marketing authorization but is, for the purposes of the trial— | |||
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| | |||
= | |||
“investigational medicinal product” means a pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical trial, and includes a medicinal product which has a marketing authorization but is, for the purposes of the trial— | |||
(a)used or assembled (formulated or packaged) in a way different from the form of the product authorised under the authorization, | (a)used or assembled (formulated or packaged) in a way different from the form of the product authorised under the authorization, | ||
(b)used for an indication not included in the summary of product characteristics under the authorization for that product, or | (b)used for an indication not included in the summary of product characteristics under the authorization for that product, or | ||
(c)used to gain further information about the form of that product as authorised under the authorization; | (c)used to gain further information about the form of that product as authorised under the authorization; | ||
}} | |||
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 — Unit 3.4.2 |
| Scope | HM |
| Document part | Article 2
investigational medicinal product |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigational drug (IMP), Definition, Placebo |
Content
“investigational medicinal product” means a pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical trial, and includes a medicinal product which has a marketing authorization but is, for the purposes of the trial— (a)used or assembled (formulated or packaged) in a way different from the form of the product authorised under the authorization, (b)used for an indication not included in the summary of product characteristics under the authorization for that product, or (c)used to gain further information about the form of that product as authorised under the authorization;
