| Current
|
The
'Herbal Safety News'
page on the MHRA
website is regularly updated and provides details of herbal medicinal product
safety issues.
|
| Current
|
'Placing a herbal medicine on the UK
market' - this section of the MHRA
website provides information on the three possible regulatory routes
by which you can legally supply herbal medicines now or in the near
future.
|
| Current
|
The
'Traditional Herbal Medicines Registration Scheme: Guidance and
information' page on 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.
|
| Current
|
'Using
herbal medicines: Advice to consumers' - this section of the MHRA
website provides general advice to consumers on what to watch out
for when buying herbal medicines
|
| Current
|
'Herbal
Medicines Advisory Committee' - this section of the MHRA
website provides details of membership of the committee and summary
minutes of meetings.
|
|
|
|
| 25
January 2005
|
The MHRA has launched a consultation
document,
MLX318:
Consultation on proposed Herbal Medicines Advisory Committee
 ,
inviting comments on updated proposals for the creation of a new
advisory committee on herbal medicines. It is proposed that the Herbal
Medicines Advisory Committee should be established as a Section 4
committee under the Medicines Act 1968. This Committee would advise
Ministers directly on areas for which the Committee is responsible. It
is proposed that the Committee’s remit would be the registration
scheme to be introduced under the Directive on Traditional Herbal
Medicinal Products and unlicensed herbal medicines. The closing date for
comments is 22 April 2005; the outcome will be published on the MHRA
website when available.
|
| 30
April 2004
|
Traditional
Herbal Medicinal Products Directive
(2004/24/EC)
|
| July
2004
|
The MHRA
has produced
a question
and answer briefing
with the most commonly asked questions by the herbal sector about the
Directive.
|
| August
2004
|
The
MHRA has issued an updated briefing note on sources
of evidence of traditional use that may be acceptable under the
Directive
|
|
Regulation
of unlicensed herbal remedies in the United Kingdom made up to meet the
needs of individual patients and statutory regulation of herbalists
|
| 2
March 2004
|
The MHRA launched the consultation document MLX
299: Proposals for the reform of the regulation of unlicensed herbal
remedies in the United Kingdom made up to meet the needs of individual
patients
seeking views
on a number of outline proposals and ideas for regulatory reform of
unlicensed herbal remedies supplied following a one to one consultation
by a herbalist. A summary of responses to
MLX 299
has been produced.
|
March
2004
February 2005
|
The
above MHRA consultation was published in conjunction with a related
consultation by the Department of Health on the regulation of Herbal
Medicine and Acupuncture Practitioners. The Department of Health
consultation: 'Regulation of herbal medicine
and acupuncture - proposals for statutory regulation'
was
followed up with a summary of responses in
February 2005
.
|
| Information
and links from 2003 or earlier
|
| 1999-2003
|
http://www.emea.eu.int/htms/human/hmpwp/hmpwppr.htm
Press
releases from Herbal
Medicinal Products Working Party (HMPWP)
|
| 9
Jan 2002
|
Statement
by French
Agency for the Safety of Health Products (AFSSAPS) (in French only,
regarding Kava)
|
| 21
Dec 2001
|
MCA
press release: Voluntary suspension
of Kava-kava sales by herbal sector following safety concerns
|
|
|
European
Herbal Practitioners Association - links to British and American
communications regarding Kava
|
| November
2001
|
MCA:
Traditional
Ethnic medicines: Public health and compliance with medicines law
|
| September
2001
|
MCA:
Review of herbal ingredients for use in
unlicensed herbal medicinal products
|
| September
2001 |
The Independent Review Panel for Borderline Products
(MCA) - Guidance on requesting a review of a provisional
determination issued by the Borderline section of the Medicines Control Agency
|
|
27/9/2001
|
MCA
Press Release: Concern
over quality and safety standards of traditional Chinese medicines
(2001/0448)
|
| 24/8/2001 |
MCA: Licensing
of Medicines: What is a medicine/borderline product?
|
| 26/7/2001 |
EMEA: Committee for Proprietary Medicinal Products (CPMP)
Note for guidance on specifications: test procedures
and acceptance criteria for herbal drugs, herbal drug preparations and herbal
medicinal products
|
| 26/7/2001 |
EMEA: Committee for Proprietary Medicinal Products (CPMP)
Note for guidance on quality of herbal medicinal
products
|
| 10/7/2001 |
EMEA:Working Party on Herbal Medicinal Products (HMPWP)
Points to consider on good agricultural and
collection practice for starting materials of herbal origin
|
| April
2001 |
EMEA: Directive on
Traditional Medicinal Products, Draft No.2
|
| 30/4/2001 |
MCA: UK response to the
2nd draft of directive on traditional medicinal products
|
9/1/2001
|
MCA:
Proposal
to confirm permanent prohibition in unlicensed medicines of Aristolochia
species and herbal ingredients which may be confused with Aristolochia
species
|
| 1999-2000
|
http://www.emea.eu.int/htms/human/hmpwp/hmpwpworkingfin.htm
Finalised working documents from Herbal
Medicinal Products Working Party (HMPWP)
|
| December
2000 |
MCA Guidance Note No.8: A guide to
what is a medicinal product
|
| 18/12/2000 |
MCA: Comments in response to
the Commission's first draft of a possible Directive on traditionally used
medicines
|
| 8/11/2000 |
European
Commission: Provisions of a Directive on
traditional medicinal products |
| 29/2/2000
|
St. John's Wort (Hypericum perforatum) interaction
information
Letter
from Professor A Breckenridge, Chairman of Committee on Safety of
Medicines. 29 February 2000
Fact
sheet for health care professionals, including specific advice for
medicines that have been shown to interact with St John's Wort
Fact
sheet for the public
|
| 28/7/1999 |
Department
of Health Press Release: Ban on supply of Aristolochia |