A Practical Guide to Licensing Herbal Medicinal Products

Answers all questions most frequently asked by manufacturers and provides full guidance on license applications.

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?
And, most importantly:
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.



Contents:
Part 1 Product Eligibility: 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: