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The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994
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- 1994 No. 3144
- SCHEDULE 3
- Regulation 9
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Offences
9. Any person responsible for placing a relevant medicinal product on the market who fails to make or maintain a detailed record of any suspected adverse reaction as required by Chapter 3 of Title II of Council Regulation (EEC) No. 2309/93, or Chapter Va of Council Directive 75/319/EEC shall be guilty of an offence.
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