The Medicines (Products for Human Use) (Fees) Regulations 2012

Fees for amendments to clinical trial authorisations

This sectionnoteType=Explanatory Memorandum has no associated

19.  (1)  A person who sends a valid notice of amendment under regulation 24 (amendments by the sponsor) of the Clinical Trial Regulations(1) relating to amendment of the dossier accompanying a request for authorisation in accordance with paragraph 11 of Part 2 of Schedule 3 (request for authorisation) to those Regulations must pay the fees mentioned in paragraph (2).

(2) The fees referred to in paragraph (1) are—

(a)the fee prescribed in paragraph 44 of Schedule 2 in connection with that amendment; and

(b)in respect of an inspection of a site made in connection with the application, the fee payable in accordance with regulations 27 to 29 and 31.

(1)

Regulation 24 has been amended by S.I. 2006/1928, 2010/551.