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The Medicines (Control of Substances for Manufacure and Exportation of Specified Products for Human Use) Amendment Order 1994

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Explanatory Note

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This Order amends the Medicines (Control of Substances for Manufacture) Orders 1971 and 1985, limiting the application of those Orders to substances for veterinary use. Those Orders extend the application of specified provisions of the Medicines Act 1968 to certain substances which are not themselves medicinal products but which are used as ingredients in the manufacture of medicinal products.

The Order revokes the Medicines (Exportation of Specified Products for Human Use) Order 1971, which excepted certain classes of medicinal products for human use (antigens, antitoxins, Sera, antisera, toxins and vaccines) from the postponement of the operation of sections 7 to 47 of the Medicines Act 1968. The effect of the revocation is that the operation of the restrictions in relation to the exportation of the medicinal products specified in that order is postponed under section 48 of that Act, and consequently exportation of such products need not be in accordance with a product licence granted under that Act (although for exportation of such products to a member State of the European Community, a wholesale dealer’s licence is required by virtue of section 49A of that Act).

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