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

Explanatory Note

(This note is not part of the Order)

This Order and the Medicines (Exemption from Licences and Certificates) (Clinical Trials) Order 1995 (S.I.1995/2809), which comes into force immediately after this Order came into force, together effect the revocation and replacement of the Medicines (Exemption from Licences) (Clinical Trials) Order 1981 (“the 1981 Order”). The 1981 Order granted, in respect of medicinal products for use in clinical trials, exemption from restrictions imposed by Part II of the Medicines Act 1968 (“the Act”) on certain dealings in medicinal products without product licences or clinical trial certificates. The 1981 Order specified conditions subject to which the exemption applied, and provided for the termination of the exemption in specified circumstances.

Article 3 of this Order exempts specified dealings in medicinal products, for the purposes of a clinical trial, from the restrictions in section 7 of the Act. By virtue of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I.1994/3144), section 7 no longer applies in relation to medicinal products that are “relevant medicinal products” as defined in regulation 1. The exemption conferred by article 3 is subject to the conditions and provisions set out in articles 4 and 5 of, and Schedule 1 and 3 to, this Order.

The principal changes from the conditions imposed by the 1981 Order are that:

(1) in accordance with article 4(1)(a)(iii), the supplier must submit to the licensing authority, in addition to the particulars and summaries and the doctor’s certificate referred to in article 4(1)(a)(i) and (ii), a usage guideline (article 2(1)(a) and Schedule 2);

(2) in accordance with article 4(1)(c)(i), the supplier must undertake to inform the licensing authority forthwith of any serious unexpected adverse reactions associated with the administration of the medicinal product; the 1981 Order required an undertaking to inform of any adverse reactions or effects;

(3) the number of matters in respect of changes in which article 4(1)(c)(iii) requires the supplier to undertake to inform the licensing authority is reduced, and the matters now include the usage guideline;

(4) there is no requirement to submit to the licensing authority the names and qualifications of investigators.

Article 6 amends the 1981 Order so as to replace the exemption it granted from the restrictions imposed by section 7 of the Act with the exemption in article 3 of this Order.