The Human Medicines Regulations 2012

[F1 Variations of converted EU marketing authorisations submitted to EMA after IP completion day but before the data submission date U.K.

12.— (1) This paragraph applies where a holder of a converted EU marketing authorisation—

(a) notifies the EMA of, or applies to the EMA for, a variation of the EU marketing authorisation to which the converted EU marketing authorisation relates during the period beginning with IP completion day and ending on the day before the data submission date; and

(b) wishes the variation to be made in relation to the converted EU marketing authorisation.

(2) Where the variation is a minor variation of Type IA—

(a) the variation may be implemented in relation to the converted EU marketing authorisation at the same time as it may be implemented in relation to the EU marketing authorisation to which the converted EU marketing authorisation relates;

(b) the holder of the converted EU marketing authorisation must (subject to paragraph 13), include in the baseline data—

(i) a summary of the variation, and

(ii) if the notification has been rejected by the EMA, an indication of that fact; and

(c) the variation to the converted EU marketing authorisation is deemed to be accepted unless the licensing authority notifies the holder in writing within the period of 30 days beginning with the data submission date that the variation is rejected, in which case the holder must cease to apply the rejected variation immediately after receipt of the notification.

(3) Where the variation is a minor variation of Type IB, a major variation of Type II or an extension which has not been rejected by the EMA—

(a) the holder of the converted EU marketing authorisation must submit to the licensing authority—

(i) the notification of, or application for, the variation, and

(ii) (subject to paragraph 13) the baseline data; and

(b) the licensing authority must consider the application in accordance with Schedule 10A.]

Textual Amendments

F1 Sch. 33A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 7 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 193); 2020 c. 1, Sch. 5 para. 1(1)