A Practical Guide to Licensing Herbal Medicinal Products
Do you manufacture herbal products?
Have you applied for registration of your products yet?
Licensing of herbal products in the European Union is changing. The Traditional Herbal Medicinal Product Directive (THMPD) was implemented and allows herbal products to be registered under medicines law. By 2011, every pharmaceutical company manufacturing herbal medicines that are sold in the European Union must have obtained licenses for their products to be marketed.
As a manufacturer of such products, you need to ask the following:
What type of herbal products are you manufacturing?
Are you required to license your herbal products and what type of license do you need?
Would your product comply with regulations?
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?
A Practical Guide to Licensing Herbal Medicinal Products is a
handbook that answers all these questions and also provides full
guidance on license application, including how forms should be
filled in, who they should be submitted to and what costs are
involved. As part of the publication process, the text was subjected
to rigorous review by eminent experts in the field, including the
Medicines and Healthcare products Regulatory Agency (MHRA).
All the official legal guidelines and forms are included within the
book, which also includes step-by-step guidance on filling out the
application forms.
Published in ring-binder format – this book will be easy and
practical to use in guiding you and your company from the initial
decision making process through to receiving a license.
Available 2009
Price: £250.00/ $395.00
ISBN: 978 0 85369 784 8
To Order
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