The Human Medicines Regulations 2012 No. 1916

SCHEDULES

[F1 SCHEDULE 10A U.K. Variations to a UK marketing authorisation

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)

Measures to close the procedures specified in paragraphs 6 to 8 U.K.

10.   Where reference is made to this paragraph, the licensing authority must take the following measures—

(a) inform the holder as to whether the variation is accepted or rejected;

(b) where the variation is rejected, inform the holder of the grounds for the rejection; and

(c) where necessary, amend the decision granting the UK marketing authorisation in accordance with the accepted variation within the time limit laid down in paragraph 15.]