asked the Minister for Health the means that exist for the testing of drugs and medicines when they are imported into this country for the first time.
Ceisteanna—Questions. Oral Answers. - Drugs and Medicine Testing.
4.
Under the European Communities (Proprietary Medicinal Products) Regulations, 1974, no medicinal product may be placed on the market in this country without a product authorisation granted by the Minister for Health on the advice of the National Drugs Advisory Board. These regulations put on a statutory basis voluntary arrangements with the pharmaceutical industry which have existed for a number of years whereby the board carry out a full assessment of all medicines before they are introduced here for the first time.
To supplement these controls certain safeguards are provided for in the Medical Preparations (Licensing of Manufacture) Regulations, 1974, and the Medical Preparations (Wholesale Licences) Regulations, 1974, which govern the adequacy of arrangements and facilities for the manufacture and wholesale distribution of medicines generally in this country.