HC Deb 12 May 1986 vol 97 c385W
Mr. McNamara

asked the Secretary of State for Social Services whether Generics (UK) Ltd. has a United Kingdom manufacturer's licence to manufacture medicinal dosage forms or to package by limited assembly only.

Mr. Hayhoe

Generics (UK) Limited has a licence under the Medicines Acts of 1968 and 1971 to manufacture and assemble medicinal products of the description or general classification specified in the licence.

Mr. McNamara

asked the Secretary of State for Social Services if he will list the overseas sources of the manufacture of medicines in respect of which product licences have been granted to Generics (UK) Ltd.; and whether all these sources have been inspected by the British Medicines Inspectorate in the last 12 months.

Mr. Hayhoe

All information provided to the licensing authority in support of applications made under the Medicine Act 1968 is treated as confidential under that Act.

Following the grant of a product licence, brief details, not including sources of manufacture, are published in the official gazettes.

Not all the manufacturing sites listed as sources for Generics (UK) Ltd. have been inspected within the last 12 months. Inspection of United Kingdom and overseas sites are not necessarily performed on an annual basis.

The frequency of inspections is a matter for the discretion of the licensing authority taking into account all relevant factors.