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Dáil Éireann díospóireacht -
Thursday, 25 Jun 1987

Vol. 373 No. 14

Written Answers. - Pre-testing of Drugs and Pharmaceuticals.

92.

asked the Minister for Health if he has satisfied himself with the pre-testing arrangements for drugs and pharmaceuticals prior to being put on the Irish market; and if he will make a statement on whether adequate testing is done in advance for various slimming aids.

I am satisfied with the arrangements for pre-testing drugs and pharmaceuticals prior to their being placed on the Irish market.

Persons wishing to market a medical preparation in this country must supply satisfactory evidence to the National Drugs Advisory Board that pre-clinical and clinical studies, as outlined in the Board's Guidelines for Applications for Product Authorisations in respect of medical preparations, have been carried out. The board carry out a detailed assessment of the scientific data submitted and authorisations are granted or refused on the basis of the board's advice in the matter.

Slimming aids such as appetite suppressants are medical preparations and subject, therefore, to these same controls. However, very low calorie diets are not subject to specific control. The food advisory committee has recommended that these diets should be undertaken under medical supervision, preferably where they can be monitored.

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