Homeopatijos teisinis reguliavimas Europos Sąjungoje ir Lietuvoje
Legal Regulation of Homeopathy in the European Union and Lithuania

Summary/Abstract: Homeopathy is a non-traditional medical treatment which came to Europe a few hundred years ago and is presently attributed to the complementary and alternative medicine. Although the assessment of evidence on effectiveness of homeopathic medicinal products has been very contradictory, homeopathy in practice is the only form of alternative medicine that has received certain legal recognition. The paper focuses on the study of the legal regulation of homeopathy in the European Union and in national law. The author analyses the contents of the concept of ‘homeopathic medicinal product’ and the EU legal norms on harmonisation of procedures for registry of homeopathic medicinal products in the Member States. It is concluded that the market of homeopathic medicinal products in the EU still lacks coherence and unity. Registry procedures under the EU law on this category of medicinal products do not apply to some of the homeopathic products, and the Member States are provided with discretion of adopting a special registry procedure, i.e. providing requirements on their discretion with regard to pre-clinical and clinical research on homeopathic medicinal products. The introduction of mandatory simplified registry procedure for homeopathic medicinal products in all EU Member States is a positive step. The author observes that the simplified procedure in principle ensures only the safety of homeopathic medicinal products on the market, because evidence of effectiveness are not required if homeopathic medicinal products are placed on the market without therapeutic indications. In the author’s opinion, the lack of credibility of the effectiveness criterion in theory allows questioning of the status of homeopathic preparations as ‘medicinal products.’ The article also aims at analysing the legal regulation of registration, labelling and advertising of homeopathic medicinal products in Lithuania. Apparently, homeopathic medicinal products are registered in Lithuania under three types of procedures: the simplified, special, and standard procedure. The special procedure for registering homeopathic medicinal products in Lithuania was established in 2010. It provides for a possibility to register homeopathic medicinal products with certain confirmed indications, without providing all the data that is usually required to claim the right to market a medicinal product. The main features of preparation that need to be proven are: the rationality of the preparation’s composition, acceptable safety and effectiveness, and the experience of legal use in a state of the European Economic Area or in the Member States. The requirements on labelling and advertising of homeopathic medicinal products are harmonised with the EU law. The analysis of regulation of homeopathic practice in national law shows that in Lithuania homeopathy is considered as a narrow specialisation of medical practice and included in the list of licensed ambulatory health c

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