# The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994, Paragraph 8: Offences


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.

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Source: https://www.legislation.gov.uk/uksi/1994/3144/schedule/3/paragraph/8 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.