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Licensed Herbal Medicines

Under the new scheme it is still possible to register your herbal medicine as a conventional medicine. This process requires a ‘full’ data package demonstrating safety, quality and efficacy. Currently, about 500 herbal medicines hold a Product Licence (PL) or Marketing Authorisation (MA).

Why might you need to obtain a licence for your product?
If your product does not meet the criteria set out in the THMRS (for example, if you cannot produce bibliographic or expert evidence to support a claim for 30 year’s traditional use) you will need a licence to keep your product on the UK market.

A full marketing authorisation (MA) or licence for your product will take longer than the “simplified procedure” for the registration of products under the THMRS.

We can help you through every stage of the Licensing process, helping with:

Regulatory Submission Strategy
Do you know which regulatory route(s) your product is eligible for?
We can devise a strategy that combines commercial/regulatory needs!

Document compilation
Plan for early submission by building a CTD as you move through your project.

Dossier compilation and advising on regulatory procedures forms the core of our business. Our highly skilled admin support team keeps costs down and gets projects completed on time and within budget.