Of course, herbs and tinctures prescribed to patients by herbal practitioners are not subject to the DTHMP but fall under the scope of Section 12.1 of the 68 Medicines
Act. Since herbalists are using "start-up materials" to make a prescription and they are individualised, they are not considered industrially produced and are therefore not subject to EU Medicines Law (2001/83/EC). Instead they are subject to national jurisdiction (12.1).

Section 12.1
Lastly, the Herbal Medicine Regulatory Working Party has been asked by Lord Hunt to come up with suggestions for updating 12.1 provisions that allow UK herbalists to prescribe on a one-to-one basis without the need for a licence or the herbs they use. The HMRWG has been beavering away and we think that a discussion document will be ready to pass around in about a week's time. I know that everyone will want to take a close look at the proposals when they are issued. The proposals will of course go out to general review before being written up as part of the HMRWG's report due in Spring this year. After that, they are likely to be published by the MCA as an MLX discussion document for public review at the same time as the DH publishes its public consultation document on SSR.
Michael McIntyre
27/01/2003

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