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The Medicines (Exemption from Licences and Certificates) (Clinical Trials) Order 1995
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- 1995 No. 2809
- Explanatory Note
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Explanatory Note
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This Order comes into force immediately after the coming into force of the Medicines (Exemption from Licences) (Clinical Trials) Order 1995 (“the Exemption Order”) and together these Orders 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 2 of this Order exempts certain dealings in medicinal products, for the purposes of a clinical trial, from the restrictions imposed by section 31(2) of the Act. The exemption is subject to the conditions and other provisions set out in articles 4 and 5 of the Exemption Order.
Article 3 revokes the 1981 Order (which was amended by the Exemption Order).
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