SCHEDULES

SCHEDULE 2U.K.Capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates

PART 4U.K.Capital Fees for Applications for Variations of Authorisations, Licences and Registrations

[F1Fees where an application for a variation or an extension of a European Union marketing authorisation had been made before IP completion dayU.K.

40A.—(1) Paragraph (2) applies where, before IP completion day —

(a)an application for a variation to which paragraph 11(7) of Schedule 33A to the Human Medicines Regulations applies, has been made to the EMA; and

(b)the Committee for Medicinal Products for Human Use has adopted a request for supplementary information to be sent to the applicant, or, in the case of an extension, day 120 has passed.

(2) Where this paragraph applies and the holder of a converted EU marketing authorisation submits the application to the licensing authority in order to have the variation made to the converted EU marketing authorisation, the fee payable under regulation 19(1) shall be waived.

(3) In this paragraph—

“day 120” means the day during the assessment of an extension 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;

“converted EU marketing authorisation” has the meaning given in paragraph 6(1) and (2) of Schedule 33A to the Human Medicines Regulations; and

“extension” has the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations.]

Textual Amendments