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At present, herbal medicines sold and supplied in the UK are governed by Section 12 of the Medicines Act of 1968. Under its terms, herbal medicines are exempt from the requirement to obtain a medicines licence as long as the following conditions are met:

  • Section 12(1) – herbal medicines are made up on the premises from which they are supplied after a personal/one-to-one consultation.
  • Section 12(2) – pre-prepared or over-the-counter (OTC) herbal medicines must not make any written therapeutic claims.

Herbal medicines sold in the UK are also exempt from European medicines licensing legislation as they are regarded as not industrially produced. (The Human Medicinal Products Directive [Directive 2001/83/EC] requires industrially produced medicines to meet standards of safety, quality and efficacy in order to obtain a medicines licence).

SI 1977/2130, The Medicines (Retail and Supply of Herbal Remedies) Order 1977, allows herbalists to use a number of potent herbs, subject to strength and dosage restrictions (commonly called Schedule III herbs).

However, the future practise of herbal medicine in the UK is under threat from the state. A trio of laws, if enacted, will bring our hitherto independent profession under state control and its herbal medicines under the aegis of the UK’s medicines regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA).

Below is an outline of the scope of the proposed legislative changes, and, more importantly, objections to their implementation.

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