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[membersforum] MHRA new info

Unlicensed herbal remedies made up to meet the needs of individual patients:

Reform of Section 12 (1) of the Medicines Act 1968

Section 12 (1) is commonly referred to as the " herbalist exemption " and 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 existence of this regime is greatly valued by herbal practitioners and by

many members of the public. However, there are widely acknowledged weaknesses in

the public health protection afforded by the regime.

Section (12) 1 remedies are not subject to a regime of specific safety or

quality requirements. There are no restrictions in terms of those who operate

under the regime. Anyone - irrespective of qualifications or experience - can

practise herbal medicine and, after, making a diagnosis and forming a judgement

about the treatment required, can make up and supply an unlicensed herbal

medicine under Section 12 (1). A number of public health risks associated with

the supply of herbal medicines by practitioners have been identified. Some of

the safety concerns that have been identified are highlighted in our " Herbal

Safety News " section.

Proposals for reform

The MHRA has been considering proposals for reform of Section 12 (1). The

proposals for reform are being developed alongside proposals for the statutory

regulation of the herbal medicine profession and build on the responses received

to the consultation exercise which took place in 2004. The Department of Health

is leading on regulation of the herbal medicine profession.

Informal discussion papers

In advance of the formal consultation exercise, informal discussion papers on

key aspects of the proposals for reform have been prepared and have been

circulated to a range of stakeholders. The documents are available below

Comments on the papers are invited by 30 March 2007. Comments should be sent to

Caroline Brennan at MHRA. The e-mail address is

caroline.brennan@....

Further information is available in the following section:

> Unlicensed herbal remedies made up to meet the need of individual patients:

Section 12(1) of the Medicines Act 1968

Page last modified: 08 January 2007