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MH04049 - Sponsor fail to report suspected unexpected serious adverse reactions in another country to the licensing authority
Important
This page shows classification data from the Active CJS Offence Index. It is not sentencing advice and does not predict what will happen in an individual case.
CJS category CE Class 3 Custody Yes PNC Yes
Classification details
- Offence code
- MH04049
- Offence title
- Sponsor fail to report suspected unexpected serious adverse reactions in another country to the licensing authority
- Legislation
- Contrary to regulations 34, 49(1)(i) and 52 of the Medicines for Human Use (Clinical Trials) Regulations 2004.
- CJS category code
- CE
- Offence class
- 3
- Custodial indicator
- Yes
- Recordable on PNC
- Yes
- Offence start date
- 01-Jan-21
- Blocked for use
- No
- XHB indicator
- No
Source data
Source: Active CJS Offence Index, June 2026. Source row: 6946.