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European Coalition on Homeopathic & Anthroposophic Medicinal Products


HMPWG consultation: First safe dilutions

Jul 26, 2017

The Homeopathic Medicinal Products Working Group (HMPWG) of the Heads of Medicines Agency (HMA) has adopted a number of new documents, all available on the HMPWG website; specifically, the second list of First Safe Dilutions (FSDs) has been published, along with an overview of comments received on the draft version.

The overview of comments includes answers from HMPWG to the comments received in the consultation. A few of the comments from the associations have been accepted by HMPWG, leading to lower FSDs; in some cases HMPWG has quoted new evidence resulting in lower FSDs. However, HMPWG does not agree with ECHAMP's main comment, which recommends following the guideline for elemental impurities, eliminating the need to perform a body weight adaption for calculations on permitted daily exposure (PDE). HMPWG states that unless otherwise indicated, the PDE is related to the body weight considered in the calculation/derivation.

The second List of First Safe Dilutions includes assessment of 52 different homeopathic stocks. It includes the method of preparation, the concentration of the toxic component, the basis for the  FSD, the acceptable amount, the reference, calculation method and the first safe dilution. The FSDs are valid only for oral dosage forms and deemed safe for all age- and patient-groups when 10g of a homeopathic preparation are applied. The aim of these lists is to improve the process to establish FSDs and to facilitate input of national experiences from Member States.

The third list of First Safe Dilutions has now also been published for public consultation. It includes 36 additional substances. ECHAMP is compiling comments for submission to HMPWG. Please send your comments to the ECHAMP office by 12 September.