asked the Minister for Health if he will indicate whether his Department has issued circulars to health boards and doctors recommending the use of untested generic drugs; and if he will make a statement on his Department's policy on the matter.
Written Answers - Use of Untested Generic Drugs.
188.
It is the policy to encourage doctors to prescribe, and pharmacists to dispense, generic products where appropriate.
A statutory authorisation system was introduced by the Medical Preparations (Licensing, Advertisement and Sale) Regulations 1984 under which all original proprietary medical preparations (and all non-proprietary generic medical preparations placed on the market after 1 October 1984) require product authorisations issued by the Minister for Health, acting on the advice of the National Drugs Advisory Board (NDAB).
In the case of generic products on the market prior to 1 October, 1984, it was decided that these should be reviewed by the NDAB before April 1989 as set out in the Second Schedule to the 1984 Regulations.
This review was structured to ensure that products with the greatest therapeutic benefit would be reviewed initially. The review is continuing and is due to be completed in April 1989.
All medical preparations, except those in categories specifically so exempted by the 1984 Regulations, must now hold a product authorisation. Remaining exempted products must obtain a product authorisation by April 1988, September 1988 or April 1989, according to therapeutic category as defined in the second schedule to the 1984 Regulations.
Since 1975, all drugs manufactured within the EC require a licence to manufacture, which includes testing in the country of origin.
Where medicinal products are manufactured outside the EC a manufacturers licence, under the Medical Preparations (Licensing of Manufacture) Regulations, 1974, is required for the importation of such products into this country.
I am satisfied that there is no evidence to suggest that any generic product on the Irish market is unsafe.
My Department has written to all the companies known to be marketing medical preparations in categories (a), (b) and (c) requesting that they withdraw all products from the market which do not have product authorisations, are not the subject of applications for product authorisations or the subject of application for review or renewal of product authorisations.