# The Human Medicines Regulations 2012, Regulation 97: Breach of pharmacovigilance condition

Extent: E+W+S+N.I.

(1) The holder of a marketing authorisation or a parallel import licence is guilty of an offence if the holder fails to comply with a condition to which the marketing authorisation or parallel import licence is subject by virtue of regulation 59 (conditions of a UK marketing authorisation or parallel import licence: general).
(2) The holder of a marketing authorisation is guilty of an offence if the holder fails to comply with a condition to which the marketing authorisation is subject by virtue of regulation 60 (conditions of a UK marketing authorisation: exceptional circumstances) , regulation 60A (condition as to the testing of samples by the appropriate authority) or 61 (conditions of a UK marketing authorisation: new obligations post-authorisation).

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/97 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-97
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.