The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003

Amendment of Schedule 5 to the General Fees Regulations

13.—(1) Schedule 5 to the General Fees Regulations (waiver, reduction or refund of capital fees) is amended as follows.

(2) After paragraph 1, insert the following paragraph—

“1A.— (1) Where the licensing authority holds a meeting with a person for the purpose of providing scientific advice and that meeting was held—

(a) at the request of the authority; or

(b) with a view to that person making—

(i) an application for a marketing authorization which includes a reclassification element within the meaning of paragraph 1A of Part II of Schedule 1, or

(ii) a reclassification variation application within the meaning of paragraph 1 of Part III of Schedule 1,

the fee payable under regulation 3B may be waived.

(2) In this paragraph, “scientific advice” has the meaning given by regulation 3A.”.

(3) In paragraph 2, after “the licensing authority” insert “or in response to the imposition of an urgent safety restriction under regulation 6A of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994”.