The Medicines (Products for Human Use-Fees) Regulations 2008

PART 5 Capital Fees for Applications for Variations of Authorizations, Registrations, Licences and Certificates and for Associated Inspections

Fees for variations of authorizations, registrations, licences and authorisations

18.—(1) Unless regulations 44 or 48 applies, the fee for an application—

(a) under regulation 4 (applications for the grant, renewal or variation of a United Kingdom marketing authorization) of the 1994 Regulations(1) for the variation of a United Kingdom marketing authorization;

(b) under regulation 6 (consideration and grant or refusal, of an application for, or for renewal or variation of, a traditional herbal registration) of the Herbal Regulations for the variation of a traditional herbal registration;

(c) under section 30 (variation of licence on application of holder) of the Act(2) for the variation of a product licence, a manufacturer’s licence or a wholesale dealer’s licence; or

(d) under regulation 44 (variation of manufacturing authorisation) of the Clinical Trials Regulations(3) for the variation of a manufacturing authorisation,

is the fee mentioned in paragraph (2).

(2) The fee referred to in paragraph (1) is—

(a) the fee prescribed in Part 4 of Schedule 1 in connection with the application; 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.

(3) Unless regulation 28 applies, the fee in paragraph (1) is payable by the applicant.

Fees for amendments to clinical trial authorisations

19.—(1) A person who sends a valid notice of amendment under regulation 24 (amendments by the sponsor) of the Clinical Trial Regulations(4) 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 23 of Part 4 of Schedule 1 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.

Applications for multiple variations

20.—(1) Unless paragraph (2) applies, a separate fee is payable in respect of each variation of each provision of a marketing authorization, traditional herbal registration, manufacturing authorisation or licence applied for in any one application.

(2) A separate fee is not payable for a variation which is wholly consequential upon another variation of a provision of a marketing authorization, traditional herbal registration, manufacturing authorisation or licence which is applied for in the same application.

(1)

Amendments to regulation 4 have been made by S.I. 2001/795, 2002/236, 2005/2759 and 2006/1952.

(2)

Section 30 was substituted by S.I. 2005/2789.

(3)

Amendments to regulation 44 have been made by S.I. 2006/1928.

(4)

Amendments to regulation 24 have been made by S.I. 2006/1928.