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Version 5.0 of Anthroposophic Pharmaceutical Codex now available

Mar 22, 2022

The International Association of Anthroposophic Pharmacists (IAAP) has published the fifth edition of the Anthroposophic Pharmaceutical Codex (APC), documenting and confirming the quality standards for the manufacture of anthroposophic medicinal products.

Licensed homeopathic and anthroposophic medicinal products comply with the quality standards of official pharmacopoeias (pharmaceutical compendia) for manufacture and quality control. Standard substances and manufacturing processes are described in specific and official Pharmacopoeias, in particular the European Pharmacopoeia (Ph. Eur.), the German Homeopathic Pharmacopoeia (HAB) or the homeopathic part of the Pharmacopée Française (Ph. Fr). Quality standards are important, as they bring recognition and help to create a legal framework for homeopathic and anthroposophic medicinal products. This gives a solid basis on which to submit dossiers for a marketing authorisation or registration, and gives the authorities a legal instrument by which to review the quality.

The International Association of Anthroposophic Pharmacists (IAAP) is an umbrella organisation that seeks to be the centre of information for anthroposophic pharmacists and to share best practice worldwide. One of its goals is to elaborate quality standards for anthroposophic medicinal products, which it does through the publication of the Anthroposophic Pharmaceutical Codex (APC). The APC provides an overview of the pharmaceutical processes and substances used in the manufacture of anthroposophic medicinal products and the related quality parameters. It describes the main anthroposophic manufacturing methods which are not described in any official pharmacopoeia of the EU Member States (although they are included in the Pharmacopoeia Helvetica) and the substances used in anthroposophic medicine, referencing other Pharmacopoeia where possible.

The introductory note (page 2) of the fifth edition document outlines the main changes compared to the previous edition.

Most importantly, 14 new substances have been added to the appendices – eight new substances in the list of starting materials of botanical origin, four new substances in the list of starting materials of zoological origin, one in the list of compositions and  one stock with special manufacturing methods. Of particular note is the new monograph for Viscum album (mistletoe), which marks a significant milestone in the history of anthroposophic pharmacy, since it is a result of a co-operation between a number of different manufacturing companies. So far only the botany is complete. The companies continue to work on the analytical part of this monograph.

This new version also takes into account the monographs and requirements of the current version of the European Pharmacopoeia (Ph. Eur. 10.8) and has changed the references for mother tinctures prepared by rhythmic procedure, known as the Rh tinctures, from the HAB reference (methods 21 and 22) to the new Ph.Eur. reference to methods 1.5.1 and 1.5.2 of monograph 2371, which will be implemented in July 2022.

For ease of use, all substantial amendments to the previous edition are marked by a line to the side of the text.

The review and update of the APC is carried out by an anthroposophic pharmaceutical committee that reports to the IAAP board. They are already looking ahead to version 5.1.

ECHAMP and its members work hard to achieve feasible and coherent standards with the different quality traditions of homeopathic and anthroposophic medicinal products in Europe, which is the centre of pharmaceutical expertise in these products. The pharmaceutical processes, including quality monographs for both starting materials and manufacturing methods, are developed in the industry, further developed with academics and confirmed by regulation.

Anthroposophic medicine is practised in 65 countries worldwide. The legal status and integration in national health systems vary greatly between countries. It is hoped the new publication will help all users to document quality standards for anthroposophic medicinal products and continue to give quality standards for those substances and preparations which are not described in an official pharmacopoeia.

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