Regulatory documents

05.08.2009

Safety issues in the preparation of homeopathic medicines

The World Health Organization has just published "Safety issues in the preparation of homeopathic medicines". It is a technical document as a response to requests and recommendations made by relevant World Health Assembly resolutions, by Member States, as well as international conferences of drug regulatory authorities, and is a part of the implementation of the WHO Traditional Medicine Strategy and the WHO Medicines Strategy.

WHO states that homeopathy is used worldwide, but that the national regulatory framework and the place of homeopathy within the health care system differ from country to country.

The document aims to provide guidance to Member States on technical aspects of the production and manufacture of homeopathic medicines that potentially have implications for their safety. This is of relevance for establishing national quality standards and specifications for homeopathic medicines, as well as for controlling their quality. The document does not address issues of efficacy or clinical utilization.

The terms used in this document are defined and annexed as a reference.

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