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European Coalition on Homeopathic & Anthroposophic Medicinal Products

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EU legislation

The authorisation for a homeopathic medicinal product to be present on the market in the EU is regulated by specific provisions in Directive 2001/83/EC on medicinal products for human use, completed with specific provisions on the proof of quality, safety and efficacy  in Directive 2003/63/EC.

Additional legislation of relevance to the legal and regulatory environment for these products includes: