A Practical Guide to Licensing Herbal Medicinal Products
Brendler, Thomas; Phillips, L Denzil; Spiess, Stefan
Thomas Brendler - Consultant, Ethnobotanist and Translator in pharmaceutical sector, L Denzil Phillips - CEO, Denzil Phillips International Ltd and Stefan Speiss - Managing Director, Gruenwalder Gesundheitsprodukte GmbH
The procedure for licensing herbal products in the UK and European Union is changing. The Traditional Herbal Medicinal Product Directive (THMPD) was implemented in the UK in 2005 and allows herbal products to be registered under medicines law. By 2011, every pharmaceutical company manufacturing herbal medicines that are sold in the UK and European Union must have obtained a market authorization.
As a manufacturer of such products, you need to ask the following:
- What type of herbal products are you manufacturing?
- Would your product comply with the regulations?
- Are you required to register your herbal products?
- What type of registration or license do you need?
- What evidence and manufacturing data do you need to provide?
- What are the packaging and leaflet requirements for your product?
- How do you apply for a license?
Reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA), A Practical Guide to Licensing Herbal Medicinal Products answers all these questions and also provides full guidance on product registration, including step-by-step guidance on completing the application forms, information on to whom the forms should be submitted and what costs are involved. All the official legal guidelines and forms are included within the guide.
This text is easy and practical to use, guiding you and your company through the initial decision-making process to registering your herbal products.
Classification of Herbal (medicinal) Products
Part 2 Content and Presentation
Proof of Tradition
Common Technical Document
Good Agricultural and Collection Practice
Quality Requirements for Traditional Herbal Medicinal Products
Safety and Pharmacovigilance: Labelling
Part 3 The Practicalities
Submission of THM Registration Applications-frequently Asked Questions
Part 4 Appendices
'I believe it represents a view of the likely future for natural health products as all herbal products there are now required to be registered under the drugs laws by 2011.'
Integrative Medicine: A Clinicians Journal, July 2009
09-Sep-09, Doody's Notes
'The book is written for companies in the EU who manufacture and sell herbal products considered medicines...the book also could be used as a teaching tool and example for students to demonstrate the rigorous process that occurs in the EU for licensing herbal medicinal products. The book is innovative in the way it gives step-by-step instructions for the regulatory process. This is a unique and timely book for companies and manufacturers in the EU who produce medicinal herbal products.'
Anna Wodlinger, Pharm.D.,BCPS, Doody's Notes, 9th September 2009
ISBN 978 0 85369 784 8
Published Apr 2009
297 x 210mm (800pp)