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HMPWG Report on the regulatory status of homeopathic medicinal products

18 Apr 2017

The Homeopathic Medicinal Products Working Group (HMPWG) has released a new report on the regulatory status of homeopathic medicinal products in EU and EFTA countries and the state of implementation of Directive 2001/83/EC as amended by Directive 2004/27/EC.

The report provides summarised answers from HMPWG members to a comprehensive set of questions (31 in total) around the implementation and management of EU legislation in this field. It includes data from 27 countries – the EU Member States excluding Estonia, Spain, Poland and UK, plus Switzerland, Lichtenstein and Norway.

It includes answers to questions grouped under four main topics:

  • the marketing of homeopathic and anthroposophic medicinal products
  • implementation of Directive 2001/83/EC as amended by Directive 2004/27/EC, both articles 14 and 16.2
  • the specific national regulatory status of homeopathic medicinal products, including old and existing products pre-1993
  • the national experience of registering/authorising homeopathic medicinal products, including data on fees in each Member State, information on how they handle variations, indications and labelling, information on adverse reactions, renewals, the mutual recognition procedure and authorisation of manufacturing sites.

The questions mostly concern homeopathic medicinal products but there are some specific questions on anthroposophic medicinal products as well. The data was collected between March and December 2016 and adopted by HMPWG in February 2017.

ECHAMP warmly welcomes this report, which provides comprehensive regulatory information for our sector. The report brings transparency for agencies and companies. It is hoped that this will make it easier for agencies to share best practice particularly with regards to proportionate regulation and availability of homeopathic and anthroposophic medicinal products.