Homeopathic medicinal products

Directive 2001/83/EC on medicinal products for human use outlines two procedures for market access of homeopathic and homeopathically produced anthroposophic medicinal products:

• Special Simplified Registration Procedure (Article 14)
• Marketing Authorisation (Article 16).

The Special Simplified Registration Procedure (simplified registration) applies to homeopathic medicinal products that comply with the following criteria:

• They are administered orally or externally
• No specific therapeutic indication appears on their labelling
• There is a sufficient degree of dilution to guarantee their safety; in particular they may not contain more than 1 part per 10,000 of the mother tincture or more than 1:100th of the smallest dose used in allopathy with regard to active substances whose presence in an allopathic medicinal product results in the obligation to submit a doctor’s prescription.

Those products which do not comply with these criteria need to be authorised in accordance with Article 16. As a consequence, the general marketing authorisation procedures for allopathic medicinal products are in principle applicable to homeopathic medicinal products which are not eligible for a simplified registration.

However, Member States have the competence under Article 16(2) to retain or introduce specific rules for pre-clinical tests (pharmacological and toxicological tests) and clinical trials in accordance with the principles and characteristics of homeopathy as practised in that particular Member State. Thus they are able to adopt special rules to make an assessment of safety and efficacy.

The reason for failing to make the authorisation mandatory all over the EU is described in Recital 25 of 2001/83/EC:

“(…) In particular, those Member States which have a homeopathic tradition should be able to apply particular rules for the evaluation of the results of tests and trials intended to establish the safety and efficacy of these medicinal products provided that they notify them to the Commission”. 

The main reasons for creating a solid European legislation were to safeguard public health, eliminate disparities which affect the functioning of the internal market, not hinder the development of the pharmaceutical industry or trade of medicinal products in the community, remove hindrances to approximate relevant provisions. These are fully put aside as regards homeopathic medicinal products subject to an Article 16.2 marketing authorisation, despite the fact that homeopathy is a European tradition, practised and used in all the EU Member States.  

For further information

• Questions and answers document on regulatory and legal issues concerning homeopathic medicinal products in the European framework,  Homeopathic Medicinal Products Working Group (HMPWG) of the Heads of Medicines Agencies, 2020
• Michels et al., Safety, pharmacovigilance and appropriate information for patients of homeopathic medicinal products, Pharmazeutische Industry 80(11):1473-1480, 2018
• HMPWG Report on the regulatory status of homeopathic medicinal products for human use in EU and EFTA countries, 2017