[F1Guidance in respect of good pharmacovigilance practice and post authorisation efficacy studiesU.K.
205B.—(1) The licensing authority may publish—
(a)guidance on good pharmacovigilance practices for both the licensing authority and UK marketing authorisation holders;
(b)scientific guidance on post authorisation efficacy studies.
(2) Subject to paragraph (3), the guidance issued by the Commission under Article 108a of the 2001 Directive on the matters specified in paragraph (1)(a) and (b) continues to apply until the date on which the licensing authority publishes guidance under paragraph (1).
(3) The licensing authority—
(a)may determine that provisions of the guidance specified in paragraph (2) no longer apply, or apply subject to specified modifications, from a date that it specifies; and
(b)must, if it so determines, publish its determination.
(4) Guidance published under paragraph (1), or which applies by virtue of paragraph (2) (as modified by any determination under paragraph (3), as the case may be), is to be taken into account in consideration of whether there has been any failure to comply with a provision in this Part, or Schedule 12A, to which the guidance is relevant.]
Textual Amendments
F1Reg. 205B and cross-heading inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 169; 2020 c. 1, Sch. 5 para. 1(1)