The Medicines (Exemption from Licences) (Clinical Trials) Order 1995

Article 4(1)(a)(i)

SCHEDULE 1 PARTICULARS AND SUMMARIES WHICH ARE TO ACCOMPANY A NOTICE GIVEN OR SENT UNDER ARTICLE 4(1)(a)

1.  The name and address of the supplier and any other name under which he carries on business.

2.—(a) The name and address of any person taking part, in the course of a business carried on by him, in the manufacture or assembly of the medicinal product, and

(b) in the case of an imported product, the name and address of the manufacturer or assembler of the medicinal product in the form in which it is to be imported.

3.  The name or proposed name of the medicinal product or, where it has not been given a name, the designation by which the supplier identifies that product.

4.  The chemical structural formula for each active constituent or, where an active constituent is the subject of a monograph, the monograph name if preferred.

5.  A description of the pharmaceutical form in which the medicinal product is to be administered.

6.  The specification of the medicinal product including a statement of its qualitative and quantitative composition, giving the constituents whether active or not, and including all colouring matter, flavouring agents and perfumes.

7.  In respect of each constituent, whether active or not—

(a) the approved name or the monograph name, or

(b) where there is no approved name or monograph name, a designation by which it can readily be identified.

8.  A description of the containers used for the medicinal product and a statement of any special directions given by the manufacturer for storage and transport.

9.  The proposed dosage and its duration, and the methods and routes of administration, of the medicinal product.

10.  A description of the proposed clinical trial including the duration of the trial, the number of patients involved and a description of how safety will be monitored during the trial.

11.—(a) A summary of pharmaceutical data in respect of the method of synthesis or preparation of each active constituent and, where appropriate, the results of physico-chemical tests to substantiate the structure of the compound, or

(b) where the active constituent is the subject of a monograph, the monograph name, if preferred.

12.—(a) Where a specification has been established for a constituent—

(i) a summary of pharmaceutical data in respect of the specification of each such constituent (whether active or not) or, where a constituent is the subject of a monograph, the monograph name, if preferred,

(ii) in the case of each constituent (whether active or not), a summary of pharmaceutical data in respect of the quality control procedures and methods to be applied to ensure compliance with the specification of that constituent;

(b) where a specification has not been established for a constituent, a batch characterisation for each batch of that constituent to be used in the clinical trial.

13.  A summary of pharmaceutical data in respect of—

(a) the method of manufacture or assembly of the medicinal product,

(b) the procedures and methods employed and specifications used in the process of manufacture or assembly to ensure the uniformity of each medicinal product (together with evidence of the stability of the medicinal product and of its bio-availability for the use intended), and

(c) the methods to be employed during manufacture for determining the identity, purity and potency of the medicinal product (together with the address of the premises where such processes are to be carried out).

14.  Summaries of reports and evaluations of any experimental and biological studies and of other preclinical, clinical or laboratory studies carried out with each medicinal product or its constituents, which in the view of the supplier are relevant to the assessment of the safety, quality or efficacy of the medicinal product, together with references to relevant publications or other clinical trials.