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Paragraph 9 Offences

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

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.