New legislation for homeopathic medicinal products in Slovenia

Homeopathic products have been recognised as medicines in Slovenia since 2006 but it has not been possible to distribute them in pharmacies until the Medicines Law was implemented.

Now, the National Assembly of the Republic of Slovenia has adopted a new Medicinal Products Act (ZZdr-2; Zakon o zdravilih) on 24 February 2014. It was published in the Official Gazette of the Republic of Slovenia, No. 17/2014 on 7 March (http://www.uradni-list.si/1/objava.jsp?urlid=201417&stevilka=539) and entered into force on 22 March.

The act applies to homeopathic medicinal products as well, as clarified in Article 1. Article 6 (22) defines a homeopathic medicinal product. Article 53 defines the rules for homeopathic medicines, with Article 53 (4) requiring the Minister to issue regulations within 18 months of the enforcement of this Act (ZZdr-2).

Rules on homeopathic medicinal products for human use (Official Gazette of the Republic of Slovenia, No. 94/2008) will be in force until new regulation is issued.

Useful contacts:
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia: http://www.jazmp.si/en/
Slovenian Homeopathic Society: http://www.shd.si/