Comment on stability testing for herbal formulations.
Answers
Particular legal requirements for quality control and stability studies of herbal medicinal products (HMPs) focus on those aspects that are absolutely essential.
Up until recently, Herbal Medicinal Products (HMPs) were mostly marketed in the UK as functional food products under section 12.2 of the Medicines Act. In line with the harmonisation of legislation on herbal medicines across the EU, Directive 2004/24 EC on Traditional Herbal Medicinal Products (THMPD) (1) was implemented in the UK on 30 October 2005. After this, companies were not allowed to introduce new (T)HMPs onto the market without complying with this minimum registration. Observers believe that only a very few products are likely to go the whole course of a full marketing authorisation, as the high requirements that a product has to meet to get an HMP-licence for “well established (medicinal) use” (WEU) make this an extremely difficult venture. Existing products can still be sold until the end of the transitional period, April 2011. Those companies that want to keep their products on the market will need a new registration before that date.