The Human Medicines Regulations 2012

Duties of licensing authority in connection with determination U.K.

64.—(1) This regulation applies if the licensing authority grants a UK marketing authorisation.

(2) The licensing authority must inform the holder of the authorisation of the summary of the product characteristics as approved by the authority.

(3) The licensing authority must ensure that the summary of the product characteristics continues to match the version it has approved, subject to any changes it approves.

(4) As soon as is reasonably practicable after granting the marketing authorisation, the licensing authority must make available publicly—

(a) the marketing authorisation;

(b) the package leaflet;

(c) the summary of the product characteristics;

[F1 (d) any conditions—

(i) in the case of a UKMA(NI) [F2 or UKMA(UK)(Category 2)], established in accordance with Articles 21a, 22 and 22a of the 2001 Directive;

(ii) in the case of UKMA(GB) [F3 or UKMA(UK)(Category 1)], imposed under regulations 59 to 61; and]

(e) any deadlines for the fulfilment of those conditions.

(5) The licensing authority must draw up an assessment report and make comments on the file as regards—

(a) the results of the pharmaceutical and pre-clinical tests, the clinical trials, the risk management system and the pharmacovigilance system of the product to which the authorisation relates; or

(b) in the case of a national homoeopathic medicinal product within the meaning of Schedule 10, the information submitted under paragraphs 3 to 5 of that Schedule.

(6) The licensing authority must—

(a) revise the assessment report whenever new information becomes available that is of importance for the evaluation of the quality, safety or efficacy of the medicinal product;

(b) make the assessment report publicly available (with the omission of information of a commercially confidential nature) as soon as is reasonably practicable after it has been prepared or revised; and

(c) include in the assessment report a summary, written in a manner that is understandable to the public, that contains, in particular, a section relating to the conditions of use of the medicinal product.

(7) The assessment must be provided separately for each indication that is authorised.

Textual Amendments

F1 Reg. 64(4)(d) substituted (31.12.2020) by S.I. 2019/775, reg. 69 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 52)

F2 Words in reg. 64(4)(d)(i) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 52(a)

F3 Words in reg. 64(4)(d)(ii) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 52(b)