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Medical Treatments

Volume 485: debated on Monday 15 December 2008

To ask the Secretary of State for Health what steps his Department takes to protect patients from the risk posed by the varying bioequivalence of therapies used for the same indication; and if he will make a statement. (241549)

All medicines are licensed in accordance with European directive 2001/83/EC on human medicinal products. Each different medication used for an indication will undergo a full and thorough evaluation of its quality, safety and efficacy by the Medicines and Healthcare products Regulatory Agency (MHRA).

Generic products, which are non-branded formulations of an established product that has been licensed for at least eight years in the European Community, are not required to generate original clinical data to prove the safety and efficacy of the active medicinal substance that they contain. However they are assessed for bioequivalence with the branded reference product to ensure that they have the same therapeutic effect.

Details about the product will be set out in the Summary of Product Characteristics, which helps prescribers to choose which product to prescribe by providing them with the necessary information about the use of the product, its dosage and any necessary safety warnings or precautions for use as well as information about possible side effects. An equivalent document, the Patient Information Leaflet informs and educates patients about the medicines prescribed for them including information on how to take or use it appropriately.