This new section has been specifically created to provide guidance and information to those operating within the herbal medicine sector who, in the course of the review of existing herbal product licences (PLs), may wish to apply for a traditional herbal registration (THR) under simplified arrangements to replace their existing PL.
As the review proceeds the MHRA will use this webpage to provide information on progress and to give any further guidance that may prove helpful in the light of experience.
Purpose of the review
The review has been set up to reflect the fact that for historic reasons some, mostly older, herbal products received a PL largely on the basis of evidence of traditional use rather than demonstrated efficacy. 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 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. (Both categories of product meet standards of safety, quality and patient information.) The review may therefore lead, following case by case consideration, to the transfer of some of products with PL status to the category of a THR.
Guidance on the review procedures
Following the consultation launched in August 2008 the MHRA has produced the following guidance on the review of herbal product licences (marketing authorisations)
(803Kb).
The guidance sets out MHRA expectations of companies, gives advice and provides a contact point for companies to raise any queries and to submit their provisional plans as required under the review.
Progress
MHRA received the first applications for transfer to THR under this review process in mid 2009. See Traditional herbal medicines registration scheme for information on numbers.
Impact on businesses
It was not necessary to carry out a full impact assessment for this review. However, an outline impact assessment (242Kb) has been prepared.
Contacts for further information
Any enquiries about this guidance should be sent by email to: thmrsqueries@mhra.gsi.gov.uk or write to MHRA, 5M, 151 Buckingham Place Road, Victoria London, SW1W 9SZ
