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News from HMPWG

Jul 25, 2016

The Homeopathic Medicinal Products Working Group (HMPWG) of the Heads of Medicines Agencies (HMA) has released a number of new documents, including a consolidated list of justified stocks for homeopathic use, new rules of procedure and the report of their most recent meeting in April.

Homeopathic use

HMPWG has now published a consolidated list of justified stocks; this is a non-exhaustive list of homeopathic stocks whose homeopathic use is considered satisfactorily justified in accordance with the requirements laid down in ‘Points to consider on the Justification of homeopathic use of the stock’ of June 2012. The list includes the name of the stock, a reference to the European Pharmacopoeia and/or in absence thereof a Pharmacopoeia currently used officially in the member states and the description of the raw material as defined in the Pharmacopoeia (chemical substance or herbal). It includes all previously released lists, each of which is still available separately on the HMPWG website.

The Preamble to the consolidate list of justified stocks has also been published, as well as the overview of comments received on the previous draft of the preamble with responses, including comments from ECHAMP.

Meeting report

The public report of the 23rd meeting of the HMPWG, held in Utrecht in April, is now available.

Amongst others topics, it reports on the following: the term ‘administered orally and externally’ will not be elaborated in the next update of Chapter 1 of the Notice to Applicants due to lack of agreement on the interpretation of this definition amongst the competent authorities; the publication of a consolidated list of stocks with justified homeopathic use (see above); the first draft list of first safe dilutions and the preamble to the first list (currently under consultation); consultation on microbial limits; the adoption of the final points to consider on safety of homeopathic medicinal products from biological origin; amended rules of procedure (see below); work by the Quality sub-working group to launch a work-sharing procedure on draft assessment of nosodes.

The next meeting will be held in Switzerland 10-11 November 2016.

Rules of procedure

A new version of the rules of procedure has been released, as amended by the HMWPG at their 23 meeting in Utrecht in April to take account of new specific paragraphs referring to the activities of the host country.

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