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European Coalition on Homeopathic & Anthroposophic Medicinal Products

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The first steps towards EU harmonisation of national pharmaceutical law were taken in the 1960s with the adoption of Directive 65/65/EEC. Homeopathic medicinal products were explicitly excluded (see recital 8 and Article 34 of Directive 75/319/EEC) until 1992 when Directive 92/73/EEC on homeopathic medicinal products was adopted. Anthroposophic medicinal products produced in accordance with a homeopathic manufacturing procedure were included under the scope of this Directive.

Directive 92/73/EEC on homeopathic medicinal products came into force on the 1 January 1994. Its primary aim was the completion of the internal market. However, the second recital of the preamble indicates that the Directive also sought to protect public health. It was introduced to harmonise national rules on homeopathic medicinal products for human use and to facilitate free circulation of safe and high quality homeopathic medicinal products. The intention was to eliminate the differences between national rules and administrative practices, which were impeding the free movement of homeopathic medicinal products, distorting competition between manufacturers and depriving patients of access to the medicinal products of their choice.

1965 -2015 - a timeline of regulation for homeopathic and anthroposophic medicinal products

The Directive intended to take account of the specific characteristics of homeopathic and anthroposophic medicinal products which have been produced in accordance with a homeopathic manufacturing procedure.

In 2001, existing fragmented EU pharmaceutical legislation was codified in Directive 2001/83/EC, including the existing legislation on homeopathic medicinal products. The Commission stated in its report on the application of Directive 92/73/EEC in 1997 that the introduction of a Directive that harmonises the registration regime of homeopathic medicinal products did not remove the disparities between the national regimes in the member states. Due to hesitant positions of certain member states towards homeopathically-produced medicinal products, it was decided to amend Directive 92/73/EEC only slightly during its inclusion in Directive 2001/83/EC as part of the general codification of the EC pharmaceutical law. This process started in November 2001 by merging the existing Directives into one text. Since Directive 2001/83/EC mainly represented a re-codification of existing rules, it did not fundamentally change the rules for homeopathically-produced medicinal products.

Subsequent revisions of Directive 2001/83/EC in 2003 and 2004 brought about more substantive modifications. Firstly, Directive 2003/63/EC inserted specific provisions on the proof of quality and safety of homeopathic medicinal products by amending Annex I providing more clarity for the assessment of applications. Secondly, the adoption of Directive 2004/27/EC opened up the possibility of using the Mutual Recognition Procedure/Decentralised Procedures for products eligible for simplified registration.