The Medicines for Human Use (Clinical Trials) Regulations 2004

PART 2REQUEST FOR AUTHORISATION

1.  The name and address of—

(a)the sponsor,

(b)if the sponsor is not established in the European Community, his legal representative,

(c)if any person has been authorised by the sponsor to make the request on his behalf, that person,

(d)if the persons taking responsibility for the initiation, management and financing (or arranging the financing) of the clinical trial have allocated responsibility in accordance with regulation 3(4), any person responsible for carrying out the functions of the sponsor under Part 4 or 5 of these Regulations, and

(e)any other person to whom the sponsor has delegated any of his responsibilities in relation to the proposed trial.

2.  If any person is specified as a person responsible for the duties of the sponsor under regulation 28(2) and (3) in relation to the trial—

(a)the name and address of that person; and

(b)the trial sites in relation to which they are so responsible.

3.  The address of each trial site and the names and address of the investigator responsible for the conduct of the trial at each site.

4.  Where the trial is to be conducted at trial sites in another EEA State, a list of the competent authorities to which a request for authorisation has been made.

5.  A copy of the ethics committee opinion in relation to that trial, if available.

6.  A description of any investigational medicinal product to be used in the trial.

7.  The name and address of the person responsible for the manufacture or importation of any finished investigational medicinal product to be used in the trial and the details of any authorisation referred to in Article 13 of the Directive held by that person.

8.—(1) The address of any premises at which any batch of finished investigational medicinal products to be used in the clinical trial has been, or is to be, checked in accordance with Article 13(3) of the Directive.

(2) If an investigational medicinal product to be used in the clinical trial has been, or is to be, imported from a third country, a statement from the qualified person at the disposal of the person holding the authorisation referred to in Article 13 of the Directive in relation to that importation specifying—

(a)the address of any premises outside the European Economic Area at which the product was manufactured or assembled; and

(b)the manufacturing or assembling operations performed at those premises.

9.  A description of the proposed clinical trial.

10.  The protocol for the proposed trial.

11.—(1) Subject to sub-paragraph (7), a dossier on each investigational medicinal product to be used in the trial (“investigational medicinal product dossier”), compiled in accordance with the following sub-paragraphs.

(2) In all cases the dossier must contain a summary assessment of the potential risks and benefits of the use of the product in the proposed trial.

(3) In the case of an investigational medicinal product, other than a product referred to in sub-paragraphs (4) to (7), the dossier must contain—

(a)summaries of the chemical, pharmaceutical and biological data on the active substance and the finished product;

(b)summaries of the non-clinical pharmacology and toxicology data on that product, if available; and

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

(4) In the case of an investigational medicinal product which has a marketing authorization, the dossier must contain—

(a)a copy of the summary of product characteristics;

(b)if there has been a change—

(i)to the process of manufacture of the product or its active substance, or

(ii)of manufacturer of that product or substance,

the summaries referred to in sub-paragraph (3)(a);

(c)if the product is to be used in the trial after it has been blinded, the summaries referred to in sub-paragraph (3)(a), in so far as they relate to the blinded product; and

(d)if the product is to be used other than in accordance with the terms of the summary of product characteristics under that authorization, the summaries referred to in sub-paragraphs (3)(b) and (c), in so far as that data relates to such use.

(5) In the case of an investigational medicinal product which does not have a marketing authorization, but where—

(a)another pharmaceutical form or strength of that product has a marketing authorization; and

(b)the investigational medicinal product is supplied by the holder of that authorization,

the dossier must contain the summaries referred to in sub-paragraph (3)(a), in so far as they relate to the finished product to be used in the trial, and the summaries referred to in sub-paragraph (3)(b) and (c), in so far as they relate to the product to be used in the trial.

(6) In the case of an investigational medicinal product which does not have a marketing authorization, but where—

(a)another medicinal product containing the same active substance has a marketing authorization; and

(b)the investigational medicinal product is supplied by the manufacturer of that other product,

the dossier must contain the summaries referred to in sub-paragraph (3)(a), in so far as they relate to that other product, and the summaries referred to in sub-paragraph (3)(b) and (c), in so far as they relate to the product to be used in the trial.

(7) Where the investigational medicinal product is a placebo, the dossier must contain the summaries referred to in sub-paragraph (3)(a), in so far as they relate to that product.

(8) A dossier relating to an investigational medicinal product is not required if—

(a)the product has been used in a clinical trial that has been authorised, or is to be treated as having been authorised, by the licensing authority for the purposes of these Regulations; and

(b)the sponsor of that trial authorises the licensing authority to refer to the dossier submitted in relation to that trial.

12.  A description or sample of the labelling which is to appear on each investigational medicinal product when supplied to a subject in the trial.