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

Amendment of Schedule 1 to the General Fees Regulations

9.—(1) Schedule 1 to the General Fees Regulations (capital fees for applications for, and variations to, marketing authorizations, licences and certificates) is amended as follows.

(2) In Part I of the Schedule (interpretation), in paragraph 1—

(a) after “decentralised incoming application” insert the following definition—

““EC marketing authorization” means—

(a)

a marketing authorization, or

(b)

an authorization issued by the competent authorities of an EEA State other than the United Kingdom for the purposes of Article 6 of the 2001 Directive;”; and

(b) after “new excipient” insert the following definitions—

““Phase I trial” means a clinical trial to study the pharmacology of a medicinal product when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the trial;

“Phase II or Phase III trial” means a clinical trial, other than a Phase I trial, where the medicinal product being tested—

(a)

does not have an EC marketing authorization; or

(b)

has an EC marketing authorization, but—

(i)

there has been a change—

(aa)

to the process of manufacture of the product or its active ingredient, or

(bb)

of manufacturer of that product or substance, or

(ii)

the product is to be used in the trial other than in accordance with the terms of the summary of product characteristics under that authorization;

“Phase IV trial” means a clinical trial other than a Phase I trial or a Phase II or Phase III trial;”.

(3) In Part II of the Schedule (capital fees for applications for authorizations, licences and certificates)—

(a) in paragraph 5, in sub-paragraph (1), after “manufacturer’s licence” insert “or a manufacturing authorisation”; and

(b) for paragraph 7 substitute—

“Clinical trial authorisations

7.— (1) Subject to sub-paragraphs (3) and (4), the fee payable under regulation 4(a) in connection with an application for a clinical trial authorisation in relation to a clinical trial of a kind described in column 1 of the following Table shall be the fee specified in the corresponding entry in column 2 of that Table.

Table

Column 1	Column 2
Kind of clinical trial	Fee payable
Phase I trial	£610
Phase II or Phase III trial where the medicinal product being tested is unknown to the licensing authority	£2700
Phase II or Phase III trial where the product being tested is known to the licensing authority	£2250
Phase IV trial	£140

(2) For the purposes of that Table, a medicinal product is known to the licensing authority if—

(a) the product has an EC marketing authorization; or

(b) the product does not have an EC marketing authorization, but where—

(i) another pharmaceutical form or strength of that product has an EC marketing authorization and the medicinal product is supplied for the purposes of the clinical trial by the holder of that authorization,

(ii) another medicinal product containing the same active substance has an EC marketing authorization and the medicinal product is supplied for the purposes of the clinical trial by the manufacturer of that other product, or

(iii) a clinical trial in which that product is, or was, being tested or used has been authorised by the competent authority of an EEA State other than the United Kingdom in accordance with Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use(1).

(3) Where the application is in relation to a clinical trial in which the medicinal products being tested or used are the same as those being tested or used in a clinical trial—

(a) in respect of which the applicant made a request for authorisation; and

(b) which has been authorised by the licensing authority for the purposes of the Clinical Trials Regulations,

the fee payable in connection with that application shall be £100.

(4) Where—

(a) the medicinal product to be tested in the clinical trial to which the application relates has been used in another clinical trial that has been authorised, or is to be treated as having been authorised, by the licensing authority for the purposes of the Clinical Trials Regulations; and

(b) the sponsor of that other trial authorises the licensing authority to refer to the dossier submitted in relation to that product in accordance with paragraph 11 of Schedule 3 to those Regulations,

the fee payable in connection with that application shall be £140.”.

(4) In Part III of the Schedule (capital fees for applications for variations of authorizations, licences and certificates)—

(a) in paragraph 7—

(i) after “7(1)(b)” insert “or (c)”, and

(ii) after “variation of” insert “a manufacturing authorisation or”;

(b) in paragraph 8—

(i) after “7(1)(b)” insert “or (c)”,

(ii) after “variation of” insert “a manufacturing authorisation or”, and

(iii) for “the licence” substitute “the authorisation or licence”;

(c) for paragraph 11 substitute—

“Clinical trial authorisations

11.— (1) The fee payable under regulation 7A(1) in connection with a notice of amendment relating to amendment to the dossier accompanying a request for authorisation to conduct a clinical trial shall be—

(a) if the amendments relate to one of the parts of the dossier specified in sub-paragraph (2) only, £100;

(b) if the amendments relate to two parts of the dossier specified in sub-paragraph (2) only, £200; or

(c) if the amendments relate to all three parts of the dossier specified in sub-paragraph (2), £300.

(2) The parts of the dossier specified in paragraph (1) are—

(a) the part containing the summaries of the chemical, pharmaceutical and biological data relating to the medicinal product tested or used in the trial;

(b) the part containing the summaries of the non-clinical pharmacology and toxicology data on that product; and

(c) the part containing the summaries of the available data from previous clinical trials of, and human experience with, that product.”; and

(d) omit paragraph 12.

(1)

OJ No. L121, 1.5.2001, p.34.