Jim Higgins
Question:180 Mr. J. Higgins asked the Minister for Health if he will outline the foreign authorisation he accepts in respect of drugs used here; and if the United States FDA drugs authorisation is acceptble.
Written Answers. - Foreign Authorisation of Drugs.
In accordance with the provisions of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984-89, no drug or medicine may be sold in this country unless it is the subject of a product authorisation granted by the Minister for Health. All applications for product authorisations are subject to assessment by the National Drugs Advisory Board and it is only following such assessment and on the advice of the NDAB that a decision to grant a licence is made.
The existence of authorisations issued in other countries, including those issued by the United States FDA, does not preclude the necessity of obtaining a separate authorisation to market a drug in this country.