Breach of pharmacovigilance conditionU.K.
[F197.—(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) [F2, 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).]
Textual Amendments
F1Reg. 97 substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 17 and reg. 97 substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 17
F2Words in reg. 97(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 94(3); 2020 c. 1, Sch. 5 para. 1(1)