6. Special cases in marketing authorisations:Homeopathic medicines

1. Homeopathic medicines

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While homeopathic preparations are not regarded akin to other medicines for treating a condition, homeopathy is established to varying degrees as an alternative medicinal field in numerous countries. In some countries, there is no specific legal framework covering the use of homeopathy, while in others, licenses are required. In the EU, Directive 2001/83/EC, provides a harmonised approach to the regulatory handling of these products. According to Article 13 of that Directive, Member States have to ensure that homeopathic medicines placed on the market within the Union are either registered according to Articles 14 and 15 or authorised according to Article 16 of that directive.