Dáil Éireann debate -
Thursday, 8 Oct 1998

Vol. 494 No. 6

Written Answers. - Medicinal Products Regulations.

Ivor Callely

Question:

91 Mr. Callely asked the Minister for Health and Children the regulations in place on the use of alternative medicines; the effectiveness and actions of this medication; and if he will make a statement on the matter. [18980/98]

Minister for Health and Children (Mr. Cowen)

The current regulatory controls governing the sale and supply of medicinal products are set out in the Medicinal Products (Licensing and Sale) Regulations, 1998, which replaced earlier regulations dating back to 1975. These regulations, which reflect European Community requirements on the control of medicines, require that medicinal products placed on the market in Ireland, must be the subject of a product authorisation granted by the Irish Medicines Board. However, before the board will grant such an authorisation, it must first be satisfied that the product meets criteria laid down by the European Community to establish the safety, quality and efficacy of the product. The regulations, which are directed towards ensuring the health and safety of consumers, do not make any distinction between conventional pharmaceutical products and so-called alternative medicines.

Unless and until a medicinal product is authorised in accordance with the regulations, neither the effectiveness nor mode of action of the product will have been established in accordance with the requirements of the regulatory framework, the primary objective of which is to ensure that all medicinal products which are made available to the public are demonstrably safe, efficacious and of good quality.