- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Regulatory Support
(1998; 49 pages) [French] [Spanish]
The Medical Preparations (Licensing, Advertisement and Sale) Regulations 1984 provide a common statutory licensing system for all medicines, both proprietary and non-proprietary, taking into account the respective European directives. In general, a product authorization is required for a medical preparation to be imported or placed on the Irish market .
In August 1985, "Guidelines for Application for Product Authorization of Herbal Products" were issued by the National Drugs Advisory Board (replaced by the Irish Medicines Board in 1996) giving information on the requirements for their assessment . These guidelines contain detailed requirements for the plant raw material and also for finished products, but have been largely superseded by the European note for guidance, particularly in relation to the quality of herbal remedies. Safety and efficacy requirements are consistent with those required for conventional pharmaceutical products. Experimental animal studies have to be undertaken to delineate the effects of the contained substances and of the medicinal product. Where possible, comparative studies should be made with a pure drug substance having a similar effect. The tests should generally include examinations in rodents as well as in humans. In the case of a drug substance which is likely to be used in association with other drugs, account should be taken of the potential for interaction in terms of the therapeutic effects, side effects and toxicity of each drug substance concerned. Each active ingredient should make a relevant and reasonable contribution to the overall therapy, and the quantity of each active ingredient must be effective, safe and appropriate to the recommended use and range of dosage. Detailed requirements for tests of acute and chronic toxicity have to be fulfilled, e.g., a test for acute toxicity in at least three mammalian species, and a detailed list of requirements for the tests of chronic toxicity .
Until the end of 1995, it had not been possible to identify a simplified procedure for dealing with assessment of such products based upon the waiving of any requirement for efficacy and/or safety. It was hoped to address this as part of the remit of the Irish Medicines Board in 1996 .
An information sheet on Borderline Products was issued by the Department of Health in 1988  attempting to explain the position of these products under the regulations. Products containing herbal ingredients are considered to be medical preparations under the regulations when the labelling or accompanying or associated literature makes any preventive, curative or remedial claim, or any of the herbal ingredients present is recognized as having medicinal properties. An illustrative list of such herbs is included as an annex listing about 100 herbs with these properties. Preparations consisting of dried, crushed or comminuted herbs labelled in a manner which specifies the herb and the process of production are excluded from the scope of the regulations provided no other name is given to the preparation and no recommendation as to use as a medicinal preparation is made. Examples of such exempted products would include Senna leaves, Senna pods and Carrageen moss . The information memorandum on borderline products issued by the Department of Health in 1988 was updated in 1990. However, principles alluded to in the 1988 document remain valid .
In December 1993, the Food Safety Advisory Committee prepared a Report on Food Supplements and Health Foods to the Minister for Health and the Minister for Agriculture, Food and Forestry . The report addresses the question of an appropriate policy for the control of products which are on the borderline between foods and medicines, including natural materials the composition and status of which may have not been established, such as herbal extracts, herbal teas, essential oils. These products should be subject to authorization by the regulatory authority prior to marketing. Reference is made to the memorandum of the Department of Health on Borderline Products . With respect to herbal teas, a regulatory framework is recommended to ensure that no potentially toxic plants are marketed as herbal teas, that all the plant materials comply with stringent quality standards, and that problems of environmental contamination of herbal materials (e.g., the need for statutory controls on levels of pesticides, heavy metals and radionuclides in teas) are taken into account. Where medicinal benefits are claimed or imaginative labelling suggests such benefit for herbal teas, they should be regarded as medicines and therefore regulated by the National Drugs Advisory Board (replaced by the Irish Medicines Board in 1996). Materials for use as herbal teas should not be permitted by the appropriate regulatory authority unless they have GRAS (generally recognized as safe) status, or are recommended as acceptable for inclusion in food by the Council of Europe, or have been approved for food use by another authoritative body. Quality control should be guaranteed in accordance with the European Pharmacopoeia. With respect to essential oils, it is recommended that they should not be permitted unless they have been approved for use as flavouring substances and natural sources of flavourings by the Council of Europe, have been granted GRAS status, or have been accepted for food use by other authorities. Furthermore, it is recommended that the regulatory authority draw up a list of herbal substances which are toxic under normal conditions of use. All products included in this category of natural materials, the composition and status of which may not have been established and which are marketed for their health giving properties such as herbal extracts, herbal teas, essential oils etc., should be subject to prior authorization to establish their quality and safety before gaining access to the market .
The Food Safety Advisory Committee report on food supplements and health foods has not yet been formally implemented in terms of national legislation. The NDAB, up to the end of 1995, was still applying the recommended dietary allowance cut-off point for vitamins and mineral substances, above which these products were classified as medicinal products requiring authorization before marketing. This is another area being addressed by the Irish Medicines Board in the context of more recent European legislation .