The Human Medicines Regulations 2012

[F1 Renewals of converted EU marketing authorisations sought in advance of the data submission date U.K.

18.— (1) If a holder of a converted EU marketing authorisation submits an application for renewal in accordance with regulation 66 or 66B before the data submission date, it must, unless sub-paragraph (2) applies, provide to the licensing authority with the application such information concerning the product to which the converted EU marketing authorisation relates as may be specified in writing by the licensing authority for this purpose and published on or before IP completion day.

(2) If a holder of a converted EU marketing authorisation wishes the licensing authority to consider a renewal application before the data submission date but does not provide the information described in sub-paragraph (1) with the application, the licensing authority may agree to consider the application if it is satisfied that—

(a) the renewal may be necessary on urgent safety grounds;

(b) the renewal may be necessary in order to maintain supplies of a particular medicinal product to patients in the United Kingdom; or

(c) there are other good reasons for considering the renewal in advance of the data submission date.]

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)