Paragraph 10 Measures to close the procedures specified in paragraphs 6 to 8F1
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.
Annotations
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)