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:
- Directive 2004/24/EC introduces rules on ‘traditional herbal medicinal products’
- Directive 2004/27/EC provides general amendments
- Directive 2009/53/EC introduces rules on variations to the terms of marketing authorisations for medicinal products
- Directive 2011/62/EU prevents entry into the legal supply chain of falsified medicinal products
- Directive 2010/84/EU and Directive 2012/26/EU provide legislation on pharmacovigilance