"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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