Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 unexpected adverse reaction: 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=5 | ||
| | |unit=5.1.4 | ||
|scope=HM | |||
|doc_part=Article 2 | |||
unexpected adverse reaction | unexpected adverse reaction | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
| | |contributors= | ||
| | |tags=TAG-00331-Une-irk ++ TAG-00003-Adv-cht ++ TAG-00244-Def-ini ++ TAG-00067-Exp-war | ||
|tags_display=[[Glossary:TAG-00331-Une-irk|Unexpected adverse reaction]], [[Glossary:TAG-00003-Adv-cht|Adverse reaction]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00067-Exp-war|Expectedness]] | |||
|comment=Definition of unexpected adverse reaction (UK) | |||
|content=“unexpected adverse reaction” means an adverse reaction the nature and severity of which is not consistent with the information about the medicinal product in question set out— | |||
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“unexpected adverse reaction” means an adverse reaction the nature and severity of which is not consistent with the information about the medicinal product in question set out— | |||
(a)in the case of a product with a marketing authorization, in the summary of product characteristics for that product, | (a)in the case of a product with a marketing authorization, in the summary of product characteristics for that product, | ||
(b)in the case of any other investigational medicinal product, in the investigator’s brochure relating to the trial in question. | (b)in the case of any other investigational medicinal product, in the investigator’s brochure relating to the trial in question. | ||
}} | |||
Latest revision as of 13:50, 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 5 — Unit 5.1.4 |
| Scope | HM |
| Document part | Article 2
unexpected adverse reaction |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Unexpected adverse reaction, Adverse reaction, Definition, Expectedness |
Content
“unexpected adverse reaction” means an adverse reaction the nature and severity of which is not consistent with the information about the medicinal product in question set out— (a)in the case of a product with a marketing authorization, in the summary of product characteristics for that product, (b)in the case of any other investigational medicinal product, in the investigator’s brochure relating to the trial in question.
