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

Clinical trial authorisations

32.—(1) Unless sub-paragraphs (3) and (4) apply, the fee payable under regulation 12(1)(a) in connection with an application for a clinical trial authorisation for a clinical trial of a kind described in column 1 of the following table is the fee specified in the corresponding entry in column 2 of that table.

Fees for clinical trial authorisation applications

Column 1 Kind of clinical trial	Column 2 Fee payable
Phase I trial	£2,255
Phase II or Phase III trial where the medicinal product being tested is unknown to the licensing authority	£4,244
Phase II or Phase III trial where the product being tested is known to the licensing authority	£3,448
Phase IV trial	£265

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

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

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

(i) another pharmaceutical form or strength of that product has an EU 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 EU 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 licensing authority 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 is £265.

(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 is £265.

(1)

OJ No. L 121, 1.5.2001, p.34. This Directive has been amended by Regulation (EC) No. 1901/2006 (OJ No. L 378, 27.12.2006, p.1), to which amendments which are not relevant to these Regulations have been made.