The THMPD has a 2011 deadline, by which time all herbal products in the EU’s 27 member states seeking to make claims must register through the appropriate national medicines agency.
In the UK, most medicinal herbal products have previously fallen under a marketing authorisation (MA) system that has governed drugs and other products. But increasingly, herbal products holding MAs sit uneasily alongside the 2004 THMPD, which passed into UK law in 2005.
New guidance
Minutes released today from a June 25 meeting of the Herbal Medicines Advisory Committee (HMAC) highlight how about 50 companies and hundreds of herbal products holding MAs, are being affected by the new rules.
An industry source said the implication is that company’s holding MAs should seek Traditional Herbal Registration (THR) or face rejection for want of clinical or other data when their MAs are up for assessment, about every five years.
While the THMPD registration process has been criticised for a pharma-like approach to scientific safety and efficacy data, it is feared companies seeking re-authorisation under the existing UK laws will face even tougher criteria.
The growing consensus is that companies are better off facing the THR process, than sticking with existing MAs.
Clarity to a complex market
The HMAC noted at the June meeting that, “a flexible approach is proposed which will gradually transfer the products from MA to THR status by 2011.”
It added: “It is hoped that the move will bring clarity to a complex market for the benefit of consumers and companies.”
The Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on the matter in August, and was currently assessing responses, its press officer Florence Palmer told NutraIngredients.com.
“Several hundred products would be affected by the proposed review,” she said. “A number of them are not currently marketed.”
The fact some products “are not currently marketed” yet up for transition to THR status is a result of a clause in a related directive that strips products of their MA if they are not marketed for a period of three years or longer. By submitting to the THR process, their MA status is preserved until the matter is resolved.
The THMPD was created in part in recognition of the fact that some herbal products could not meet MA requirements, and required a unique classification.
Simplified procedure
In its August guidance, which became effective yesterday, the MHRA said the “the arrangements entail the MHRA permitting a company to make a simplified THR application for a product that will replace the existing MA.”
But the industry source said the full detail of this simplified procedure remained “a little woolly”. He lauded the fact the MHRA had waived registration fees for MA-THR transitions.
To date in the UK, there have been 47 THR applications, of which 21 have been granted. None have as yet been rejected.
MA holders with questions can contact the MHRA here.