Paragraph 3 Licensing authority recommendation on unclassified variationsF1

(1)

Prior to the submission of a variation whose classification is not provided for in this Schedule—

(a)

the holder may request a recommendation on the classification of the variation from the licensing authority; and

(b)

the licensing authority must notify the holder of its recommendation within 45 days of that request, beginning with the date on which the request is received by the licensing authority.

(2)

The 45-day period referred to in sub-paragraph (1)(b) may be extended by 25 days where the licensing authority deems it necessary.

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)