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HMPWG consultations: First Safe Dilutions and Microbial Limits

06 Jun 2016

New public consultations from Homeopathic Medicinal Products Working Group (HMPWG) address the important topics of first safe dilutions and microbial limits:

First safe dilutions

HMPWG has released a first List of First Safe Dilutions (FSDs) for consultation. In its Preamble to the First List of First Safe Dilutions (FSD), it explains that its aim is to improve the process to establish FSDs and to facilitate input of national experiences from Member States. The Preamble explains the structure and content of this first list.

The first List of First Safe Dilutions includes assessment of 17 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.

Microbial limits

A further document for consultation, Points to Consider on the Selection of Microbial Limits for Non-Sterile Homeopathic Raw Materials, Stocks, Preparations and Products has also been released. Its intention is to provide harmonised guidance on the selection of the most appropriate microbial limits during the different stages of the manufacture of a homeopathic medicinal product in order to facilitate consistent assessment and mutual recognition. The guidance relates to both Article 14 (simplified procedure) and Article 16 (marketing authorisation) products. It includes a decision tree for each of raw materials, homeopathic stocks, homeopathic preparations and finished products.

ECHAMP is compiling and submitting comments to HMPWG on all these documents. Please send your feedback directly to the office by 5 August 2016