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Information for Manufacturers, Importers, Wholesalers & Retailers |
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Medicines & Healthcare products Regulatory Agency (MHRA) website
The MHRA website provides comprehensive information on most aspects of herbal medicine legislation. Below you will find links to specific pages. www.mhra.gov.uk |
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This part of the site outlines the regulatory routes by which you can legally supply herbal medicines.
The following guidance document is essential reading for all those considering placing a herbal medicine on the UK market.
Guidance for Retailers, Wholesalers, Importers and Manufacturers on Registering Herbal Medicines under the THMR Scheme
"It covers whether a product can be placed on the UK market, the restrictions that apply, who is responsible for applying for registrations or other relevant licences, and what these processes involve. " |
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This area of the MHRA website provides information designed to help those operating
within the herbal medicine sector to understand and comply
with the Traditional Herbal Medicines Registration
Scheme (THMRS), as required by Directive 2004/24/EC on Traditional
Herbal Medicinal Products
(scroll down their first page for the latest THMRS news) |
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This page of the MHRA website provides a full list and links to all of their guidance notes, including Guidance Note 8: A guide to what is a Medicinal Product. |
| New guidance on consumer advertising for registered traditional herbal medicines |
Draft guidance for companies advertising registered traditional herbal medicines to the public.
New Guidance on consumer advertising for Registered Traditional Herbal Medicines |
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The THR certification mark is a type of trade mark. It indicates that the herbal medicine has been registered with the MHRA under the Traditional Herbal Registration (THR) scheme and meets the required standards relating to its quality, safety, evidence of traditional use and other criteria as set out under the Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC.
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| Transfer of herbal marketing authorisations to traditional herbal registration status |
The MHRA have created a new section on their website to provide guidance and information to those operating within the herbal medicine sector who, in the course of the review of existing herbal product licences (PLs), may wish to apply for a traditional herbal registration (THR) under simplified arrangements to replace their existing PL.
Following the consultation launched in August 2008 the MHRA has issued guidance on the review of herbal product licences (marketing authorisations). The review may lead, following case by case consideration, to the transfer of some of these products into the category of traditional herbal registration. The purpose of the review is to ensure that ultimately herbal products are in the appropriate regulatory category so that it is clear to the consumer which products are licensed on the basis of evidence of efficacy and which are registered on the basis of evidence of traditional use. (Both categories of product meet standards of safety, quality and patient information.) The guidance sets out MHRA expectations of companies, gives advice and provides a contact point for companies to raise any queries and to submit their provisional plans under the review. As the review proceeds the MHRA will use the website to provide periodic information on progress and to give any further guidance that may prove helpful in the light of experience. For this review a full impact assessment was not necessary. However, an outline impact assessment has been prepared.
[Taken direct from the MHRA website]
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Borderline Products |
Find out how the MHRA decides what is or isn't a medicine. |
| Borderline Products Guidance from the European Commission |
Guidance documents on whether a product is classified as a Cosmetic.
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UK Public Assessment Reports for herbal medicines
The MHRA has a statutory obligation to publish a Public Assessment Report (UKPAR) on its website following the registration approval of a product. The UKPAR includes the full Summary of Product Characteristics (SPC) and a copy of the packaging information, including the Patient Information Leaflet.
This information can be very helpful to companies considering registration of their products. |
MHRA
Press Release |
Ipsos MORI report shows that 77% of adults agree that it is important that herbal medicines are regulated [January 2009]. |
Some of the documents referred to on this page are pdf documents .
They can be viewed using Adobe Acrobat viewer which can be downloaded free from www.adobe.com. |
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