§ Mr. Gareth Wardellasked the Secretary of State for Social Services if he has any plans to increase the conspicuousness of warning labels on those drugs which, when taken in combination with alcohol, increase the risks of driving a motor vehicle.
§ Mrs. CurrieI shall let the hon. Member have a reply as soon as possible.
§ Mr. McNamaraasked the Secretary of State for Social Services if Generics (UK) Limited, has a manufacturing licence to produce medicinal products within the United Kingdom.
§ Mr. NewtonGenerics (UK) Limited has a licence under the Medicines Act 1968 and 1971 to manufacture and assemble within the United Kingdom products of the description or general classification specified in the licence.
92W
Number of registrations of newly diagnosed cases of all forms of leukaemia (ICD(9)1 204–208) by age group under age 20 years and Regional Health Authority of usual residence, England 1983 Age group Area of usual residence Under 1 1–4 5–9 10–14 15–19 Northern Regional Health Authority Males 1 4 3 3 6 Females — 6 3 3 2 Yorkshire Regional Health Authority Males — 5 3 4 5 Females 1 3 2 1 1
§ Mr. McNamaraasked the Secretary of State for Social Services whether his Department has inspected all the overseas manufacturing sites of products supplied to the National Health Service by Generics (UK) Limited.
§ Mr. NewtonThe principal overseas manufacturing sites for products for which Generics (UK) Limited holds United Kingdom product licences have all been inspected as part of the Department's regular inspection programme. One further site remains to be visited and this is scheduled for early next month.
§ Mr. McNamaraasked the Secretary of State for Social Services (1) whether his Department has received any information from the Australian Department of Health in respect of a generic medicine, glibenclamide, supplied by Alphapharm (PTY) Limited; and whether, in view of Alphapharm's links with Generics (UK) Limited, he is satisfied that no supplies of this particular preparation have reached the United Kingdom market;
(2) if his Department has received any information from the Australian Department of Health with regard to some 20 generic medicines tested in a South African quality control laboratory, which are being investigated by the Australian regulatory authorities; and whether he is satisfied that bioavailability data generated in the same South African quality control laboratory has not been used to support product licence applications to the United Kingdom licensing authority on behalf of Generics (UK) Limited or any other importers.
§ Mr. NewtonWe are aware of the allegations made in Australia and are in touch with the authorities there. We have no evidence of any hazard affecting patients in the United Kingdom but we are keeping the matter under close review and will take appropriate action should it be needed to safeguard the health of patients. On the questions about particular data, all information provided to the licensing authority in support of applications made under the Medicines Act 1968 is treated as confidential under that Act.