HC Deb 04 March 1986 vol 93 c121W
Mr. Michael Morris

asked the Secretary of State for Social Services (1) what steps are taken to seek to establish that every generic product has an identical bioequivalence as the original licensed proprietary product;

(2) what research is done to assess the bioequivalence of any recently introduced generic product.

Mr. Whitney

Before the licensing authority will license any generic medicinal product, it considers whether a lack of bioequivalence would constitute a hazard for reasons of safety or lack of efficacy. Where it considers that such a hazard would exist it will not issue a licence until it has received, and been satisfied by the results of, in-vivo bioavailability studies in support of the licence application. Where the product is a solid dose form, the licensing authority must also be satisfied with the results of in-vitro studies, which the applicant is required to submit, on the liberation and dissolution rate of the active ingredient or ingredients.

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