§ Mr. Spearingasked the Secretary of State for Social Services what directives have been issued by the Council or Commission of the Common Market concerning manufacture of medicinal products; and what steps she contemplates in order to comply with such directives.
§ Dr. OwenThe Council of Ministers of the Community approved in principle on 11th February a draft directive relating to the approximation of legal and administrative requirements relating to the marketing of proprietary medicinal products, which contains provisions relating to manufacture. These require the holding of a manufacturer's authorisation and the observance of minimum conditions designed to safeguard, in the interests of public health, the quality of the proprietary medicinal products that are authorised to be on the markets of the countries concerned.
Member states would have 18 months from the date when adoption of the directive is formally notified in which to take any measures necessary to apply it. Practically all the requirements are already satisfied by the existing arrangements in the United Kingdom under the Medicines Act 1968. No decisions have yet been taken with regard to the remainder.