The Medicines for Human Use (Clinical Trials Fees Amendments) Regulations 2004

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) In paragraph 3—

(a) in sub-paragraph (1)—

(i) for “or a clinical trial certificate, or for the renewal of a clinical trial certificate” substitute “, an application for a clinical trial authorisation or a notice of amendment to a clinical trial authorisation”,

(ii) for “7(1) or 10” substitute “7(1) or 7A(1)”,

(iii) after “that application” substitute “or notice”, and

(iv) in paragraph (a), after “application” insert “or notice”; and

(b) in sub-paragraph (3)—

(i) for “or a clinical trial certificate, or for the renewal of a clinical trial certificate” substitute “, an application for a clinical trial authorisation or a notice of amendment to a clinical trial authorisation”,

(ii) for “7(1) or 10” substitute “7(1) or 7A(1)”, and

(iii) after “that application” insert “or notice”.

(3) In paragraph 4, after “variation to,” insert “a manufacturing authorisation or”.

(4) In paragraph 4A, for “or a clinical trial certificate” substitute “or an application for a clinical trial authorisation”.

(5) Paragraph (5) is renumbered as sub-paragraph (1) of that paragraph and—

(a) in that sub-paragraph—

(i) after “manufacturer’s licence” insert “or manufacturing authorisation”, and

(ii) after “both such licences” insert “, or that authorisation and that licence”; and

(b) after that sub-paragraph, insert the following sub-paragraph—

“(2) Where the same site is inspected at the same time in connection with applications for the grant or variation of both a manufacturing authorisation and a manufacturer’s licence, or during the currency of that authorisation and that licence, the fee otherwise payable under these Regulations in respect of the inspection relating to the manufacturer’s licence or the fee otherwise payable in respect of the manufacturing authorisation, whichever is lower, shall be waived.”.

(6) After paragraph 7, insert the following paragraph—

“8.— (1) In relation to an application for a clinical trial authorisation in relation to a Phase I trial or a Phase II or Phase III trial, the fee payable in respect of such an application may be reduced in accordance with the following paragraphs.

(2) Where the licensing authority is satisfied that the investigational medicinal product dossier submitted in accordance with paragraph 11 of Schedule 3 to the Clinical Trials Regulations does not require a full medical, scientific or pharmaceutical assessment, the fee may be reduced by an amount which the authority considers to be the cost of the assessment work which is not required.

(3) The fee payable may not be reduced below £100.

(4) Where the fee has been reduced by the licensing authority but the applicant has paid the full fee, the amount by which the fee has been reduced shall be refunded to the applicant.”.