Vol. 516 No. 6
273 Ms Clune asked the Minister for Health and Children if he will give details of his request to the Irish Medicines Board to establish a national licensing system for products sold in health shops and alternate pharmacies; if he has specified particular products; the scale he has put on the investigation; and if he will make a statement on the matter. [8683/00]
285 Ms O. Mitchell asked the Minister for Health and Children in view of the recent declaration by the UK committee on safety of medicines that St. John's Wort is an inherently safe product, the plans, if any, he has to have it made available here as an across the counter product. [8891/00]
298 Ms Clune asked the Minister for Health and Children if he has examined the decision of the United Kingdom Medicines Control Agency not to confine the sale of St. John's Wort to prescription; the reasons for its decision and the proposal by the agency for labelling changes; whether these changes could be implemented here; and if he will make a statement on the matter. [9039/00]
299 Ms Clune asked the Minister for Health and Children if he will provide details of his request to the Irish Medicines Board to establish a national licensing systems for products sold in health shops and alternative pharmacies; if he has specified specific products; and if he will make a statement on the matter. [9040/00]
I propose to take Questions Nos. 273, 285, 298 and 299 together.
The licensing of traditional use or herbal medicinal products is an issue which is being addressed by a working group set up by the EU Pharmaceutical Committee last year. As an early resolution to the difficulties of harmonisation in this area is not anticipated, I have asked my officials and the Irish Medicines Board to investigate the possibility of establishing a simplified interim national licensing system for traditional use medicinal products which would allow such products to be lawfully marketed here. I understand that an initial meeting to discuss this matter will take place later this week.
Under the Medical Preparations (Licensing and Sale) Regulations, 1996, the IMB is the competent authority in this country for the assessment and licensing of all medicinal products including herbal medicinal products. In 1999, following an assessment of an application for a product authorisation, the IMB recommended to my Department that products containing St John's Wort should be subject to prescription-only control in view of safety concerns which it had identified. Further evidence has subsequently emerged confirming the IMB's concerns in this matter, and a number of other national regulatory authorities have also recently issued warnings in regard to these products, including the Food and Drugs Administration in the United States, the European Medicines Evaluation Agency of the European Union and the Medicines Control Agency in the United Kingdom which recently published its concerns regarding the potential of St John's Wort to interact with other commonly prescribed medicines. As the expert authority in this country, the IMB advises my Department in these matters and it has not recommended any change in the current regulatory status of St John's Wort arising from the actions of the aforementioned regulatory bodies.
