"The MHRA
has been considering proposals for reform of Section
12(1). The proposals for reform are being developed
alongside the DH-led work on regulation of the herbal
medicine profession.
On 3 August 2009, the DH issued
a consultation
document (external link) on whether practitioners
of acupuncture, herbal medicine and traditional Chinese
medicine should be regulated." This consultation
closed on 16 November; an assessment of the responses
is expected in March 2010.
Unlicensed
herbal remedies made up to meet the needs of individual
patients: Section 12(1) of the Medicines Act 1968. This
“herbalist exemption” permits unlicensed
remedies to be made up and supplied by a practitioner
to meet the needs of an individual patient following
a one to one consultation.
The MHRA are
proposing reform of 12(1), but may need to reconsider
the programme as their proposals until now have been
based on the premise that there would be statutory regulation
of herbal practitioners, the timing of which is not
as yet confirmed.
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 also been produced.
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