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Paragraph 8 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 report to the licensing authority any suspected adverse reaction, or to submit to the licensing authority any records of suspected adverse reactions 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.