Manufacturers Specials Licence

Section 8(2) of the Medicines Act 1968 requires those involved in the manufacture or assembly of a medicinal product to hold a manufacturer s licence. In fact. Schedule 1 to 1994 Regulations requires the manufacturer/assembler in the United Kingdom of an unlicensed product for particular patient supply to hold a particular type of manufacturer s licence (a manufacturer s special licence). It should also be noted that Section 23 of the act prohibits the manufacture of a medicinal product unless that product has a marketing authorisation, or is exempt from the marketing authorisation requirement. 

There are also special measures to control narcotic and psychotropic medicines. Their manufacture needs special licence. The Ministry of Health performs the tasks concerning the licit traffic of these medicines, required by the United Nations International Narcotic Control Board. 

The original provisions date back to the early 1970s. Under section 7(2) of the Medicines Act 1968, it was necessary to hold a product licence in order to sell, supply, export or import a medicinal product to procure those activities or for the manufacture or assembly of the product. However, various exemptions from the licensing requirements, including those relating to particular patient supply, were provided for in the act and in related statutory instruments. The most important exemptions were contained in sections 9 and 13 of the act, the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971, the Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972 and the Medicines (Exemptions from Licences) (Importation) Order 1984. ... 

Ideally, extemporaneous products are prepared from pure drugs (or less suitably from chemicals) but, more frequently, commercial dosage forms intended for adults are manipulated into a suitable form for administration to children. They should be prepared in registered premises (pharmacy, hospital, health centre) under the supervision of a pharmacist and in accordance with a prescription for administration to a particular patient or in anticipation of such a prescription. These manipulations come under the heading of magistral (extemporaneous) preparations. Specials have a similar status but are made in larger volumes by licensed manufacturers (licence issued by the MHRA in the UK), which include suitably licensed hospital units. However, these products are not always subjected to full quality assurance. 

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