SCHEDULE 3PARTICULARS AND DOCUMENTS THAT MUST ACCOMPANY AN APPLICATION FOR AN ETHICS COMMITTEE OPINION, A REQUEST FOR AUTHORISATION, A NOTICE OF AMENDMENT AND A NOTIFICATION OF THE CONCLUSION OF A TRIAL
PART 2REQUEST FOR AUTHORISATION
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.