The Human Medicines Regulations 2012

[F1 Publication of information relating to paediatric marketing authorisations U.K.

58B.— (1) The licensing authority must publish a register of UK marketing authorisations—

(a) which include a paediatric indication following completion of an agreed paediatric investigation plan; and

(b) in relation to which the medicinal product was placed on the market for other indications before the holder obtained that paediatric indication.

(2) The register referred to in paragraph (1) must include the date by which the product must be placed on the market taking account of the paediatric indication in accordance with regulation 78A(4) (post-authorisation requirements in relation to UK marketing authorisations to which paediatric specific provisions apply).

(3) The licensing authority must publish a list of the marketing authorisation holders which have—

(a) benefitted from any of the rewards in regulation 58A; or

(b) failed to comply with any of the obligations in regulation 78A.

(4) The licensing authority must publish decisions made under—

(a) regulation 50B(5) or (7) (agreement and modification of paediatric investigation plan);

(b) regulation 50C(2) (deferral of the initiation or completion of measures in a paediatric investigation plan); and

(c) regulation 50D(2) (waiver of production of information in a paediatric investigation plan) in relation to a specific medicinal product.

(5) The decisions referred to in paragraph (4) must be published, with the omission of information of a commercially confidential nature, as soon as reasonably practicable after the decision has been made.]

Textual Amendments

F1 Regs. 58A-58G inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 64 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 47); 2020 c. 1, Sch. 5 para. 1(1)