According to Council Directive 65/65/EEC, a medicinal product is defined as "any substance or combination of substances presented for treating or preventing disease in human beings or animals." This directive further states that "any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product." Article 3 clarifies that no medicinal product may be marketed in a member state unless an authorisation has been issued by the competent authority of that member state.
In general, herbal preparations are classified as medicinal products if they claim therapeutic or prophylactic indications. Thus, herbal preparations that are intended to be used as foods, cosmetics, etc., and are not intended or presented for treating, preventing or diagnosing diseases or restoring correcting or modifying physiological functions in humans would not be classified as medicinal products and therefore would not require product authorisations. The medical claims being made on behalf of products containing St John's Wort, hypericum perforatum, require that, in this country, in common with other countries in the European Union, they be regarded as a medicinal products. Such products therefore need product authorisations in order that they may be lawfully placed on the market.
The Irish Medicines Board is the competent authority for the regulatory control of medicinal products in Ireland and under Directive 65/65/EEC it is required to establish proof of quality, safety and efficacy before granting access to the market for medicinal products. Following an application for product authorisation earlier this year, and having carried out a medical assessment, the Irish Medicines Board has recently formed the opinion that products containing St John's Wort should be subject to prescription only control and a recommendation in that regard was made to my Department.