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

Article 4(1) (a) (iii)

SCHEDULE 2 INFORMATION TO BE CONTAINED IN USAGE GUIDELINE

1.  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.

2.  A description of each clinical use to be investigated and, in respect of each such use,

(a) the nature and purpose of the clinical trial,

(b) a description of each pharmaceutical form in which the medicinal product is to be administered, and, in respect of each such form, the methods and routes by which the medicinal product is to be administered, the proposed maximum daily dosage and the proposed maximum duration of exposure to the product.

3.  The minimum and maximum ages, and the maximum number, of patients to be involved in the clinical trial, and, where the clinical trial comprises a series of investigations, the maximum number of patients to be involved in each investigation in that series.

4.  The criteria for the selection of patients for, and the exclusion and withdrawal of patients from, the clinical trial.

5.  A description of how safety will be monitored during the clinical trial.