Paragraph 24A Fees where an application for a European Union marketing authorisation had been made before IP completion dayF1

(1)

This paragraph applies where, before IP completion day —

(a)

an application has been made to the EMA for a European Union marketing authorisation;

(b)

day 120 has passed; and

(c)

no final decision has been made by the European Commission in relation to the grant of an European Union marketing authorisation under Article 10 of Regulation (EC) No 726/2004.

(2)

Where this paragraph applies and the applicant for the European Union marketing authorisation applies for a UK marketing authorisation in accordance with paragraph 31(2) of Schedule 33A to the Human Medicines Regulations, the fee payable under regulation 12(1) shall be waived.

(3)

In this paragraph, “day 120” means the day during the assessment of an application for a European Union marketing authorisation on which the Committee for Medicinal Products for Human Use adopts the list of questions, as well as the overall conclusions and review of the scientific data, to be sent to the applicant.

Annotations

Textual amendments

F1: Sch. 2 para. 24A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(6) (with Sch. 1 para. 11) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(v)(aa)(bb); 2020 c. 1, Sch. 5 para. 1(1)