# The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994, Paragraph 9: Offences


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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Source: https://www.legislation.gov.uk/uksi/1994/3144/schedule/3/paragraph/9 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-9
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.