The Human Medicines Regulations 2012

[F1 Grouping of variations U.K.

5.— (1) Except where sub-paragraph (2) applies, where several variations are notified or applied for, a separate notification or application in accordance with paragraph 6, 7, 8 or 11 of this Schedule is to be submitted in respect of each variation sought.

(2) This sub-paragraph applies—

(a) where one or more of the same minor variations of type IA to the terms of one or more UK marketing authorisations owned by the same holder are notified at the same time to the licensing authority, in which case a single notification as referred to in paragraph 6 may cover all such variations;

(b) where several variations to the terms of the same UK marketing authorisation are submitted at the same time, a single submission may cover all such variations provided that the variations concerned fall within one of the relevant circumstances specified in sub-paragraph (3);

(c) where one or more of the same variation to the terms of one or more UK marketing authorisations held by the same holder are submitted at the same time and the variations do not fall within paragraph (a) or (b), a single submission may cover all such variations provided that the licensing authority agrees to such single submission.

(3) The relevant circumstances are—

(a) one of the variations in the group is an extension of the UK marketing authorisation;

(b) one of the variations in the group is a major variation of type II, but all other variations in the group are variations which are consequential to this major variation of type II;

(c) one of the variations in the group is a minor variation of type IB, but all other variations in the group are minor variations which are consequential to this minor variation of type IB;

(d) all variations in the group relate solely to changes of an administrative nature to the summary of product characteristics, labelling and package leaflet or insert;

(e) all variations in the group are changes to an Active Substance Master File, Vaccine Antigen Master File or Plasma Master File;

(f) all variations in the group relate to a project intended to improve the manufacturing process and the quality of the medicinal product concerned or one or more of its active substances;

(g) all variations in the group are changes affecting the quality of a human pandemic influenza vaccine;

(h) all variations in the group are changes to the pharmacovigilance system referred to in paragraph 12 of Schedule 8;

(i) all variations in the group are consequential to a given urgent safety restriction and submitted in accordance with paragraph 14;

(j) all variations in the group relate to the implementation of a given class labelling;

(k) all variations in the group are consequential to the assessment of a given periodic safety update report;

(l) all variations in the group are consequential to a given post-authorisation study conducted under the supervision of the holder;

(m) all variations in the group are consequential to a condition imposed under regulation 59(4C) or (4D).

(4) The submission referred to in sub-paragraph (2)(b) and (c) must be made by means of the following—

(a) a single notification in accordance with paragraph 7 where at least one of the variations is a minor variation of type IB and the remaining variations are minor variations;

(b) a single application in accordance with paragraph 8 where at least one of the variations is a major variation of type II and none of the variations is an extension; or

(c) a single application in accordance with paragraph 11 where at least one of the variations is an extension.]

Textual Amendments

F1 Sch. 10A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 5; 2020 c. 1, Sch. 5 para. 1(1)