asked the Minister for Health the reason for charging a licence fee to Irish pharmaceutical companies manufacturing in this country; when multinational and international companies do not have to pay the fee.
Written Answers. - Medical Preparation.
32.
All manufacturers of medical preparations for human use in this country are required to hold a licence under the Medical Preparations (Licensing of Manufacture) Regulations, 1974-75. Before a licence is granted, the manufacturing plant must be inspected to ensure the adequacy of arrangements and facilities for production, quality control, distribution, record-keeping, recall etc. A fee is charged for each licence to help meet the cost of operating this inspection system. No distribution is made in charging fees between indigenous manufacturers and foreign companies manufacturing here. The same position will apply in respect of the manufacture of veterinary medicines from 1 January 1987 under the European Communities (Veterinary Medicinal Products) Regulations, 1986.