WRITTEN QUESTION No. 788/99 by Graham MATHER Commission criticism of the Medicines Control Agency (UK)
Date: 1999-04-06
Institutions: European Parliament, MATHER
Subjects: United Kingdom, application of EU law, approximation of laws, complaint to the Commission, drug surveillance, marketing standard, medicinal product, pharmaceutical legislation













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91999E0788

WRITTEN QUESTION No. 788/99 by Graham MATHER Commission criticism of the Medicines Control Agency (UK)  


Official Journal C 370 , 21/12/1999 P. 0108 





WRITTEN QUESTION E-0788/99by Graham Mather (PPE) to the Commission(6 April 1999)Subject: Commission criticism of the Medicines Control Agency (UK)The Commission has reportedly criticised the MCA, following a complaint from a section of UK industry, for its perceived failure adequately to enforce medicines legislation in "borderline" areas of product classification between foods, cosmetics, medical devices and medicinal products. The UK has now brought forward new legislative proposals in this area.1. What was the precise nature of the Commission's criticism of the MCA?2. In the Commission's view, will the proposed UK legislation answer these criticisms?3. Is the Commission satisfied that the new proposals will not unduly restrict the availability of certain products in the UK and thus disrupt the proper functioning of the internal market?Answer given by Mr Bangemann on behalf of the Commission(7 May 1999)According to Article 1 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products(1), any substance or combination of substances presented for treating or preventing disease in human beings or animals shall be regarded as a medicinal product. Likewise, any substance or combination of substances which may be administered to human beings or animals with a view to making a medicinal diagnosis or to restoring, correcting or modifying physiological functions, has to be considered a medicinal product. As a matter of general principle, ready-prepared medicinal products may only be placed on the market of a Member State if the quality, safety and efficacy has been proven in a marketing authorisation procedure.These basic provisions should have been implemented by Member States in their national legislation for many years. In the context of a complaint on a specific group of products, the Commission was, however, made aware that British law did not consistently implement the above rules with regard to all products (particularly certain "health products") on the British market. The Commission, in its function as a guardian of Community law, was therefore obliged to ask the United Kingdom to align its national legislation regarding the classification of medicinal products with the provisions of Community law.The British authorities have indicated that they intend to achieve the aim of full consistency with Community law by the swift adoption of proposed new regulations for processing the classification of medicinal products. The Commission expects that this aim will be achieved by the adoption of these new regulations and hopes that the full implementation of Community pharmaceutical legislation in the United Kingdom will contribute to the proper functioning of the internal market.(1) OJ 22, 9.2.1965.