Vol. 405 No. 3
277 Mr. Allen asked the Minister for Health if he has satisfied himself with the examination of drugs being offered to the Irish market; and if he accepts as adequate the certification from non-Irish authorities of the claims of the drug manufacturers themselves.
The Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984-89, provide that no drugs or medical preparations may be sold in this country except in accordance with a licence, known as a product authorisation, granted by the Minister for Health under the regulations.
As part of the procedure for the assessment of an application for a product authorisation, all such applications are submitted for detailed assessment to the National Drugs Advisory Board and it is only in the light of the assessment and advice of the National Drugs Advisory Board that a decision to grant a product authorisation will be made. Certification by non-Irish authorities does not exempt a product from the need for an Irish product authorisation as required by the regulations.
I am, therefore, satisfied with the assessment and examination of drugs and medicines on the Irish market.
