Ivor Callely
Question:123 Mr. Callely asked the Minister for Health the procedure for a medical preparation or drug to obtain product authorisation to be sold on the Irish market; and if there are any proposed alternations to the procedure.
Written Answers. - Product Authorisation of Medical Preparations.
Application forms and guidelines are available from my Department for persons who wish to apply for product authorisations to market medical preparations under the provision of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984, as amended. Product authorisations are issued in the name of the Minister for Health following examination of applications and advice by the National Drugs Advisory Board. There has been a Government decision to devolve authority to the board to issue product authorisation directly and the necessary arrangements for this purpose are under consideration.