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Medicines (Raw Materials)

Volume 130: debated on Monday 21 March 1988

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To ask the Secretary of State for Social Services what steps are taken to verify sources of raw materials following approval by the Committee on Safety of Medicines and the issue of generic licences by his Department.

An applicant for a product licence must state the source of all active ingredients and specify the tests and limits he will apply to them. If products are to be imported in a finished state, the applicant must detail the checks which are to be carried out on importation. In all cases, the finished products must conform with the agreed specification. Lack of compliance can result in action being considered to suspend or revoke the relevant licence.The applicant for a product licence must state the source of all active ingredients and specify the tests and limits he will apply to them. If products are to be imported in a finished state, the applicant must detail the checks which are to be carried out on importation. In all cases, the finished products must conform with the agreed specification. Lack of compliance can result in action being considered to suspend or revoke the relevant licence.The medicines inspectorate has power to check the origin of raw material in the course of its visits to pharmaceutical manufacturers and for biological raw materials checks extend back to the primary manufacturer.Samples are also taken from the market for independent analysis on behalf of the licensing authority.