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Date posted: September 7, 2011

Homeopathic medicinal products on the UK market are currently authorised either with Product Licences of Right (PLRs), or with certificates of registration under the Simplified.

Registration Scheme”.  Many of the products with PLRs carry indications, mainly for minor conditions suitable for self medication, whereas registered products, which are assessed only for safety and quality, are not permitted to be labelled with therapeutic indications.  No new PLRs have been granted since the Medicines Act came into force in the early 1970’s.

Conventional medicinal products for human use are licensed with a “marketing authorization”. The 2001 Directive sets out the particulars and documents which must accompany an application for a marketing authorization, including a requirement that the applicant submit the results of pre-clinical tests and clinical trials. Because of the philosophy of homoeopathy and the nature of the products, it is difficult to establish efficacy for homoeopathic products by way of clinical trials.

However, article 16(2) of the 2001 Directive permits member states to introduce national rules for the pre-clinical tests and clinical trials of certain homeopathic medicinal products, in order that those products can be authorised with marketing authorizations.

(Apart from special rules on safety and efficacy data, all the other rules applicable to applicants for and holders of marketing authorizations apply.) This has been achieved in the UK by the Medicines for Human Use (National Rules for Homoeopathic Products)

Regulations 2006, which amend the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994 (“the 1994 Regulations”).

As the rules do not require rigorous clinical data, indications are limited to the relief or treatment of minor symptoms or minor conditions.  i.e symptoms or conditions which can ordinarily and with reasonable safety be relieved or treated without the supervision or intervention of a doctor.  Indications for serious conditions are prohibited.

In this guidance, references to “the National Rules Scheme” are to the scheme introduced by the 2006 Regulations, under article 16(2) of the 2001 Directive.

You should note that this guidance represents MHRA’s view of the law and is not a definitive statement of the law – that can only be given by the courts. Whilst MHRA is happy to provide guidance to companies, it cannot give you legal advice. If you are in any doubt about your professional obligations you should always consult your professional advisors.

Download the complete UK National rules for Homeopathic Manufactures and Suppliers (pdf) : www.similima.com/pdf/ukpharmacy-rules.pdf

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