Vol. 527 No. 5
71 Mr. Higgins (Mayo) asked the Minister for Health and Children if his attention has been drawn to the concerns expressed by pharmacists with regard to the availability of paracetamol through retail outlets; and the case they have made for limiting such distribution. [28943/00]
The concern being expressed by pharmacists in regard to paracetamol are part of those concerns arising generally in relation to overdosages being encountered with the wide availability of this medicinal product.
The current position in relation to the sale of medicinal products containing paracetamol, both in pharmacy and non-pharmacy outlets, is based on the policy and recommendations of the Irish Medicines Board which are implemented by the board in the granting of product authorisations in respect of medicinal products to be placed or maintained on the market in this country. This board is the competent authority for the granting and renewal of the product authorisations under the Medicinal Products (Licensing and Sale) Regulation, 1998. These authorisations set out the conditions subject to which medicinal products may be placed on the market. The primary aim is to promote public health by ensuring that medicinal products available to the public meet the required standards of safety, quality and efficacy in accordance with the obligation arising from current EU and national legislative requirements.
Due to concerns arising from overdosages of paracetamol, in 1997 the Irish Medicines Board, following a request from my Department, drew up a series of recommendations in relation to the sale of paracetamol, including a recommendation to restrict the sale of paracetamol in non-pharmacy retail outlets to packs containing not more than 12 500 mg tablets or equivalent. Following extensive consultation almost all the manufacturers concerned have supported the recommendations and have agreed to conform with the board's recommendations with a view to implementing them in order to enhance public safety.
Regulations to restrict the availability of paracetamol, which would give statutory effect to the recommendations made by the Irish Medicines Board, are currently under consideration in my Department. These recommendations relate to pack size and availability in both pharmacy and non-pharmacy outlets and will, as already outlined, subject packs of paracetamol above particular pack sizes to pharmacy-only or prescription-only control as appropriate. I understand that most manufacturers are already operating within these guidelines in anticipation of the introduction of the new regulations.
