In the UK, many herbal products possess herbal product licenses (PL), but are obliged under the THMPD to obtain traditional herbal registrations (THR) before a 2011 deadline.
The cost of this process has been a bugbear of the UK herbal medicines industry, as well as the fact many of these products have been authorised due to traditional use rather than, as the MHRA puts it, “demonstrated efficacy”.
Appropriate categories
“This situation predated the European Directive on traditional herbal medicinal products which was introduced to provide a suitable regulatory home for manufactured herbal medicines with minor indications based on traditional use,” the MHRA stated.
“The purpose of the review is to ensure that ultimately herbal products are in the appropriate regulatory category so that it is clear to the consumer which products are licensed on the basis of evidence of efficacy and which are registered on the basis of evidence of traditional use.”
The MHRA has proposed a simplified herbal products registration transfer system.
“These simplified arrangements will apply where the PL product that is to be withdrawn can be regarded as a ‘corresponding product’ in relation to the THR,” it said in its review document. “Under this process withdrawal or cancellation of the existing herbal PL would then be linked to the granting of the THR.“
It added: “The review should progressively enable the sector to move to the position in which regulated over-the-counter herbal medicines are seen to come within the appropriate regulatory category. This should bring clarity to a complex market, to the benefit of both consumers and companies.”
Some products may be bale to retain their PL status, MHRA said, such as single herb laxative products based on ingredients such as senna or ispaghula.
It advised companies planning on transferring products to do the work in stages with different groups of products, and to advise MHRA in advance of their plans.
The review guidance can be found here.
The THMPD, which became law in the UK in 2005, 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.
Herbal Forum
The UK-based botanicals group, Herbal Forum, has said it is “concerned about the additional workload” in previously mooted registration proposals.
Herbal Forum members include the British Herbal Medicine Association, the UK Council for Responsible Nutrition, the European Herbal Practitioners Association, the UK Health Food Manufacturers’ Association and the Proprietary Association of Great Britain.