asked the Minister for Health if he has satisfied himself with the effectiveness of legislation prohibiting the selling of unlicensed medical preparations across the counter in pharmacies and health food shops; and if he will make a statement on the matter.
Written Answers. - Sale of Medical Preparations.
51.
am satisfied that the legislation concerned has served its purpose. Under the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984, no person may place a medical preparation on the market in this country except in accordance with a product authorisation issued by me.
These regulations were intended to ensure the quality, safety and efficacy of products on the market and in this regard the products were divided into two categories: (1) new products which required authorisation before being placed on the market, and (2) products which were previously on the market and which were to be reviewed on a phased basis leading up to 1 April 1989.
Under the EC Directive concerned this review was intended to be completed by 20 April 1990. In the regulations of 1984 it was decided to set a deadline one year earlier than that required by the EC Directive to allow sufficient time for application to be processed. The current position is that in so far as prescription medicines are concerned, the review is almost complete. However, in the case of the other products the review continues. These other products consist mainly of over-the-counter medicines including vitimin, mineral and herbal medicines in respect of which applications have been slow in coming forward.
I have reviewed the position in regard to the availability generally of all unauthorised medicines and (1) have established a firm deadline by which applications for authorisations must be made, this date will not be later than 1 November 1989; (2) propose and extend the powers of enforcement under the regulations and (3) propose to impose on wholesalers an obligation to check whether the products kept, or offered for sale, by them, are the subject of product authorisations or, as the case may be, of product authorisation applications.