The Medicines for Human Use (Clinical Trials) Regulations 2004

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.