PART 5 U.K.Marketing authorisations

Application for UK marketing authorisation U.K.

[F1 Other applications including paediatric indications U.K.

50F.— (1) This regulation applies in relation to an application to which neither regulation 50A nor 50E applies and which is—

(a) an application for a UKMA(GB) for a relevant medicinal product which includes a paediatric indication; or

(b) an application to include a paediatric indication in an existing UKMA(GB).

(2) The applicant making an application to which this regulation applies must include in the application details of the measures intended to ensure the follow up of efficacy and of possible adverse reactions to the paediatric use of the medicinal product.]

Textual Amendments

F1 Regs. 50A-50J inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 53 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 40(a)-(g)); 2020 c. 1, Sch. 5 para. 1(1)