§ Mr. Nicholas Wintertonasked the Secretary of State for Social Services what steps he proposes to take following the implementation of his proposals for a limited list of drugs to ensure that generic products which are imported into the United Kingdom meet with the same quality control requirements to which the United Kingdom industry is subject.
§ Mr. Kenneth ClarkeNo special steps are required. For any medical product, including a generic product, to be marketed in the United Kingdom, the Licensing Authority has to be satisfied that the product is safe, efficacious and of good quality under the Medicines Act 1968. The licensing authority also has to be satisfied that the product has been manufactured to acceptable standards under United Kingdom (or European Community) licensing arrangements.
§ Mr. Nicholas Wintertonasked the Secretary of State for Social Services if he will list in the Official Report all those preparations on his proposed limited list of drugs available under the National Health Service which are not currently available from the United Kingdom manufacturers.
§ Mr. Kenneth ClarkeThe limited list is not yet finalised but we expect that most if not all of the products included will be available from United Kingdom manufacturers.
§ Mr. Michael Marshallasked the Secretary of State for Social Services (1) what further representations he has received about the deadline set for the consultation period regarding the provisional limited list of drugs available through National Health Service prescriptions and about subsequent opportunities for review of any list which is introduced;
168W(2) what opportunities for subsequent review will apply to the proposed limited list of drugs available through National Health Service prescription after 1 April 1985.
§ Mr. Kenneth ClarkeWe have not specifically identified among the representations received any comments about the period allowed for consultation. The evaluation of new products after 1 April will be fully considered during our consultation with the medical and pharmaceutical professions and the drug industry.