Broughton Laboratories is offering pre-registration support for the Traditional Herbal Medicines Registration Scheme (THMRS), which demands safety and quality levels for traditional herbal medicines.
The support includes: development of analytical methods for herbal medicines, method validation to full ICH requirements and stability storage and testing to full ICH requirements.
The THMRS scheme was introduced in October 2005.
It demands that all manufactured herbal medicines placed on the UK market must have either a Traditional Herbal Registration (THR) or a Marketing Authorisation (MA).
The only exception is those products placed legally on the market under the 1968 Medicines Act by 30 April 2004, which can continue to be marketed as unlicensed herbal remedies until 30 April 2011.
The simplified procedure allows the registration of THMPs without requiring documentation on tests and trials on safety and efficacy, provided that there is sufficient evidence of the medicinal use of the product throughout a period of at least 30 years, including at least 15 years in the EU.
A summary of the stability studies undertaken, including storage conditions and the batch analytical data, is required for submission.
Analytical data is gathered at different time points throughout the study using validated methods developed specifically for the finished product.
Validation documentation is required to prove that the method used is fit for purpose.
Data relating to method sensitivity, accuracy, range of analysis and precision must be collected and submitted.
