The regulation of herbal medicine

Abstract

Abstract This paper sets out the changes to domestic legislation that will be implemented following the introduction of the new European Traditional Herbal Medicines Directive. The Herbal Medicines Regulations were drawn up in 2004 but implementation of the Directive is not required until 2011. With the date still some way off, the regulations would appear to have had little impact upon the herbal industry. Yet, the reality is that the new requirements for those manufacturing herbal medicinal products will demand preparation before compliance is possible. Manufacturers relying on the exemptions provided under section 12 of the Medicines Act may no longer be in a position to do so. A new Traditional Herbal Registration Scheme has been launched and manufacturers wanting their products to be included will need to apply to the Medicines & Healthcare Products Regulatory Authority. Changes in legislation at the European level have also meant that the question of who is a medical practitioner for the purpose of prescribing herbal medication has been raised afresh. The answer to this question may require further regulation, whether by legislative or other means.