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The Coherency of Regulatory Requirements for Homeopathic Medicinal Products in the EU and the EAEU

open-access


DOI https://doi.org/10.21552/eplr/2019/2/4

Gunther Herr, Alexander Natz, Robbert van Haselen


Similar to the EU model, a common market for medicinal products, including homeopathic medicinal products, is currently being established in the Eurasian Economic Union (EAEU). In this article, the requirements for regulatory market access of homeopathic medicinal products in the EU and in the EAEU are analyzed and compared. Difficulties in applying core requirements of both union laws correctly and coherently are identified and related proposals for a more coherent interpretation are made. Overall the communalities in both union laws contribute to market access and competition, but consistent interpretation of core terms in the regulatory framework by the Member States’ competent authorities remains the main challenge.

Alexander Natz is General Secretary of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Brussels. For Correspondence: <mailto:natz@eucope.org>. Gunther Herr is Member of EUCOPE’s Executive Board. Robbert van Haselen is the Director of the World Integrated Medicine Forum. The analysis of the Eurasian Law was aligned with Sergey Klimenko, lawyer, a member of the Healthcare Expert Board of the Council of the Deration Committee on Social Policy, Moscow.

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