ABSTRACT

Medicines with recognized efficacy are generally used in medical practice; however, registration issues are major barriers in enhancing the accountability of the herbal medicines. The Regulation member states have introduced a range of different procedures and provisions to keep these herbal preparations on the market. The normal quality requirements apply to traditional herbal medicinal products. As the efficacy of traditional herbal medicinal products is not demonstrated in the usual way, the Medicines Evaluation Board takes a cautious approach to accepting contra-indications or adverse events for these products. The Directive on Traditional Herbal Medicinal Products as published in the Official Journal of the European Union has now been transposed into Irish law by the Department of Health and Children. The Committee on Herbal Medicinal Products also has responsibility for the development of Community herbal monographs. Control is performed in all production stages: herbal drugs, herbal derivatives, and herbal medicines.