August
2010: Latest traditional herbal registration application
numbers
Since the beginning of this financial year, the MHRA
has received 31 THR applications, bringing the total
applications received since the start of the THR scheme
to 152. Sixty nine applications have so far
been granted. The most recent grants include the first
two products to be transferred from product licence
(PL) status to THR, and two products using a combination
of five herbs; the total number of different herbs
used in granted products is now 27. Information on the
registered products can be found in the public assessment
reports which are available in the section on Public
Assessment Reports for herbal medicines.
August
2010: Other news
Transitional protection under the traditional herbal
medicinal products Directive (Directive 2004/24/EC):
The guidance on transitional protection has been updated
to provide additional advice on the end of the transitional
period and how this will operate. The new material reflects
questions received by the MHRA in recent months. Changes
include the addition of a section on the impact on herbal
practitioners and their suppliers. The additional questions
start at question 15 onwards.
Guidance
on Transitional arrangements for the Directive on traditional
herbal medicinal products (Directive 2004/24/EC, amending
Directive 2001/83/EC) 
(120Kb)
New guidance
on consumer advertising for registered traditional herbal
medicines: The guidance on consumer advertising
consulted on during 2009 has been finalised and can
be found here.
Consumer
advertising for registered traditional herbal medicines
(77Kb)
October
2009: Introduction of the Traditional Herbal Registration
certification mark
The Traditional Herbal Registration (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.
For further information
please see:
Traditional
Herbal Registration certification mark
September 2009: Latest
traditional herbal registration application numbers
As of 3 September 2009 the MHRA
had received 86 THR applications and a further 2 applications
to transfer products with a product license (PL) to
a THR under the review of herbal product licences; giving
a total of 88. To date 45 THRs have been granted,
with none as yet through the review of PLs.
July 2009: Latest traditional herbal registration
application numbers
As of 3 July the MHRA had received 80 applications for
registration under the THR Scheme. The applications
cover single and combination products using 36 different
herbs. So far 35 registrations have been granted. Since
March 2009 the MHRA have received a further 13 applications
and granted 6 THRs.
May 2009: Outcome
measures for herbal strategy
The MHRA are making available a table of the outcome
measures used in relation to their strategy for bringing
herbal medicines into effective regulation. These cover
a variety of categories ranging from measures that are
already monitored frequently, to others where they have
baseline data but where changes (e.g. in public understanding
and attitude) can only realistically be measured over
a number of years. As with other areas of public policy
monitoring, interpretation of the results of policy
monitoring will need to be undertaken with care as figures
and trends are often open to more than one interpretation.
Outcome
measures of MHRA strategy to bring herbal medicine into
effective regulation
[Taken
direct from the MHRA website]
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