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

• Citation: S.I. 1995/2809
• Sections: 3

Section 1 Citation, commencement and interpretation

(1) This Order may be cited as the Medicines (Exemption from Licences and Certificates) (Clinical Trials) Order 1995 and shall come into force on 8th December 1995 immediately after the Medicines (Exemption from Licences) (Clinical Trials) Order 1995 comes into force.

(2) In this Order—

“ the Act ” means the Medicines Act 1968;

“medicinal product” includes any substance or article for human use specified in an order made under section 104 or 105(1)(b) of the Act (application of Act to certain articles and substances and to certain other substances which are not medicinal products) which is for the time being in force and which directs that sections 31 and 35(8) and (9) of the Act shall have effect in relation to that substance or article .

Section 2 Exemption from licences and certificates in respect of clinical trials

(1) Subject to paragraph (2) of this article, the restrictions imposed by section 31(2) of the Act (which restricts dealings with medicinal products for the purposes of a clinical trial) shall not apply to anything done which consists of selling or supplying, or procuring the sale, supply, manufacture or assembly of, a medicinal product for the purposes of a clinical trial.

(2) the exemption conferred by paragraph (1) of this article is subject to the conditions specified in article 4 of the Medicines (Exemption from Licences) (Clinical Trials) Order 1995 and to the limitations specified in article 5 of that Order.

Section 3 Revocation

The Medicines (Exemption from Licences) (Clinical Trials) Order 1981 is hereby revoked.