The Medicines (Exemption from Licences) (Clinical Trials) Order 1995
1Citation and commencement
2Interpretation
3Exemption from licences in respect of clinical trials
4Conditions
5Coming into effect, duration and termination of exemption
6Amendment of Order
SCHEDULE 1PARTICULARS AND SUMMARIES WHICH ARE TO ACCOMPANY A NOTICE GIVEN OR SENT UNDER ARTICLE 4(1)(a)
1The name and address of the supplier and any other...
2(a) The name and address of any person taking part,...
3The name or proposed name of the medicinal product or,...
4The chemical structural formula for each active constituent or, where...
5A description of the pharmaceutical form in which the medicinal...
6The specification of the medicinal product including a statement of...
7In respect of each constituent, whether active or not—
8A description of the containers used for the medicinal product...
9The proposed dosage and its duration, and the methods and...
10A description of the proposed clinical trial including the duration...
11(a) A summary of pharmaceutical data in respect of the...
12(a) Where a specification has been established for a constituent—...
13A summary of pharmaceutical data in respect of—
14Summaries of reports and evaluations of any experimental and biological...
SCHEDULE 2INFORMATION TO BE CONTAINED IN USAGE GUIDELINE
1The name or proposed name of the medicinal product or,...
2A description of each clinical use to be investigated and,...
3The minimum and maximum ages, and the maximum number, of...
4The criteria for the selection of patients for, and the...
5A description of how safety will be monitored during the...
SCHEDULE 3MATTERS IN RESPECT OF WHICH THE LICENSING AUTHORITY SHALL FORTHWITH BE INFORMED OF CHANGES
1(a) The name and address of any person taking part,...
2The active or inactive constituents, or the method of manufacture...
3The method of synthesis of any active constituent where such...
4Information in the usage guideline.

1995 No. 2808

MEDICINES

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

Made

Laid before Parliament

Coming into force

The Secretaries of State concerned with health in England, in Wales and in Scotland respectively and the Department of Health and Social Services for Northern Ireland, acting jointly in exercise of the powers conferred upon them by sections 15(1) and 129(4) of the Medicines Act 19681 or, as the case may be, those conferred by those provisions and now vested in them2 and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by this Order3, hereby make the following Order: