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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Draft guidance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. |
| 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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