The Human Medicines Regulations 2012

[F1 Variations of converted EU marketing authorisations notified or applied for before IP completion day U.K.

11.— (1) This paragraph applies where, before IP completion day—

(a) a holder of a converted EU marketing authorisation has notified the EMA of, or made an application to the EMA for, a variation of the EU marketing authorisation to which the converted EU marketing authorisation applies under Chapter III of Regulation (EC) No 1234/2008, or has made an application to the EMA for an extension of that EU marketing authorisation in accordance with Article 19 of that Regulation;

(b) the procedures specified in Article 17 of that Regulation (measures to close the procedures of Articles 14 to 16) have not concluded, or, in the case of an extension, no final decision has been made by the European Commission in relation to the application; and

(c) the holder of the converted EU marketing authorisation wishes the variation to be made 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 any time on or after the time at which 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 before the end of 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) the variation may be implemented in relation to the converted EU marketing authorisation at any time on or after the time at which it may be implemented in relation to the EU marketing authorisation to which the converted EU marketing authorisation relates;

(b) if the variation has not been rejected by the EMA, the holder of the converted EU marketing authorisation must (subject to paragraph 13) include a copy of the notification in the baseline data; and

(c) the variation to the converted EU marketing authorisation is deemed to be accepted unless the licensing authority notifies the holder in writing before the end of 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.

(4) Sub-paragraph (5) applies where—

(a) the variation is a major variation of Type II or an extension; and

(b) before IP completion day the Committee for Medicinal Products for Human Use gave a positive final opinion in relation to the application with which the United Kingdom concurred.

(5) Where this sub-paragraph applies—

(a) the variation may be implemented in relation to the converted EU marketing authorisation at any time on or after the time at which 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 a copy of the application in the baseline data; and

(c) the licensing authority must either—

(i) treat the variation as accepted, and, if the variation affects the terms of the converted EU marketing authorisation, amend those terms accordingly; or

(ii) notify the holder of the converted EU marketing authorisation before the end of 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.

(6) Sub-paragraph (7) applies where—

(a) the variation is a major variation of Type II or an extension; and

(b) before IP completion day the Committee for Medicinal Products for Human Use had not given any opinion in relation to the application, or had given a negative final opinion in relation to it, or had given a positive final opinion but the United Kingdom recorded a divergent opinion.

(7) Where this paragraph applies—

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

(i) the 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.

(8) In this paragraph and paragraph 12, “minor variation of Type IA”, “minor variation of Type IB”, “major variation of Type II” and “extension” have the meanings given in paragraph 1 of 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)