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HMPWG consultations: Justified stocks and Quality of raw material

13 Dec 2016

Two new public consultations from Homeopathic Medicinal Products Working Group (HMPWG) have been released, seeking comments on the fifth list of justified stocks and questions and answers on quality, specifically relating to raw materials. ECHAMP is compiling and submitting comments to HMPWG on both these documents. Please send your feedback directly to the office by 27 January 2017.

Fifth list of justified stocks

The Homeopathic Medicinal Products Working Group (HMPWG) of the Heads of Medicines Agency (HMA) has an ongoing programme to publish a list of stocks for which homeopathic use is justified. In June it published a consolidated list of justified stocks based on the first three lists that were adopted; the fourth list was adopted in November and is now available on the HMPWG website, along with an overview of comments received on the draft version of the fourth list.

These are non-exhaustive lists of homeopathic stocks whose homeopathic use is considered satisfactorily justified by the HMPWG. The list is comprised of:

  • the name(s) of the stocks including the Latin name
  • a Pharmacopoeia reference (the European Pharmacopoeia (Ph. Eur.) or in absence thereof a Pharmacopoeia currently used officially in the member states)
  • definition of the raw material.

It is the intention that these lists will act as a reliable reference document for applications for special, simplified registration of homeopathic medicinal products.

The fifth list of justified stocks has now been released for consultation.

Quality: raw material

The HMPWG sub-working group on quality was set up in February 2016 to provide information and guidance to HMPWG on quality issues relating to guidance documents and assessment of homeopathic medicinal products, on quality concerns to be adopted by HMPWG, and to help ensure a uniform assessment of quality of homeopathic medicinal products in the Member States. It published its work programme at the same time.

It has now released its first document for public consultation, a Question & Answers document on quality, addressing three questions on the topic of raw material and the suppliers of raw materials.

We welcome all input for our feedback to HMPWG.