# The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994, Paragraph 10: Offences


Any person who, while employed or engaged as an appropriately qualified person responsible for pharmacovigilance for the purposes of Chapter 3 of Title II of Council Regulation (EEC) No. 2309/93, or Chapter Va of Council Directive 75/319/EEC fails to—
(a) establish or maintain a system for collecting and collating information about suspected adverse reactions;
(b) prepare for the licensing authority a report on any such reactions; or
(c) ensure that a request from the licensing authority for the provision of additional information necessary for the evaluation of the benefits and risks afforded by a relevant medicinal product is answered fully and promptly,
as required by any provision of any such Chapter, shall be guilty of an offence.

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Source: https://www.legislation.gov.uk/uksi/1994/3144/schedule/3/paragraph/10 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-3/paragraph-10
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.