Office of Public Sector Information
12.—(1) Unless regulation 44, or 48 applies, the application fee for a marketing authorization (other than a Community marketing authorization), a traditional herbal registration, a manufacturer’s licence, a manufacturing authorisation, a wholesale dealer’s licence or a clinical trial authorisation is—
(a) the fee prescribed for that application in Part 2 of Schedule 1; and
(b) in respect of an inspection of a site made in connection with that application the fee payable in accordance with regulations 27 to 29.
(2) Unless regulation 28 applies, the fee in paragraph (1) is payable by the applicant.
13. The fee payable by an applicant for a certified copy of a certificate of good manufacturing practice issued pursuant to Article 111(5) of the 2001 Directive is £63.
14.—(1) The fee payable by an applicant for a certificate issued under section 50 (export certificates) of the Act(25), is —
(a) £141, if the applicant requests the certificate to be issued within 24 hours of receipt of the application; and
(b) £63 in any other case.
(2) The fee in sub-paragraphs (a) and (b) is for three identical signed certificates.
(3) The fee payable by the applicant for a copy of the certificate referred to in paragraph (1) is £31 for a certified copy of the certificate.
15. For the purposes of this Part and Part 3 of Schedule 1, a “set of applications” means—
(a) a number of applications to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing authorization in other EEA States, but only if all the applications relate to applications for marketing authorizations in other EEA States that have the same 90 day assessment period for the purposes of Article 28.4 of the 2001 Directive; or
(b) a number of applications to competent authorities of other EEA States for marketing authorizations relating to a single United Kingdom marketing authorization, but only if all the applications have the same 90 day assessment period for the purposes of Article 28.4 of the 2001 Directive.
16. Unless regulation 44 applies, the fee payable by an applicant to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing authorization in another EEA State or in other EEA States, is the fee prescribed in Part 3 of Schedule 1 in connection with the application or set of applications.
17. Unless regulation 39 or 44 applies, all sums payable by way of fees under regulation 16 must be paid at the time when, in connection with the application or set of applications for regulatory assistance, a request is made pursuant to the second sub-paragraph of Article 28.1 of the 2001 Directive for an assessment report to be prepared or updated.
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(26) 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(27) 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(28) 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.
19.—(1) A person who sends a valid notice of amendment under regulation 24 (amendments by the sponsor) of the Clinical Trial Regulations(29) 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.
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.
Section 50 has been amended by S.I. 2004/1031. Back [25]
Amendments to regulation 4 have been made by S.I. 2001/795, 2002/236, 2005/2759 and 2006/1952. Back [26]
Section 30 was substituted by S.I. 2005/2789. Back [27]
Amendments to regulation 44 have been made by S.I. 2006/1928. Back [28]
Amendments to regulation 24 have been made by S.I. 2006/1928. Back [29]
The Medicines (Products for Human Use-fees) Regulations 2008