Based on Article 87 of the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/2014 and 66/2019; hereinafter: ZZdr-2), medicinal products to be placed on the market on the basis of paragraphs one or two of Article 20 of the ZZdr-2, and for medicinal products from indents two, three or four of paragraphs three of Article 20 of the ZZdr-2 to be issued in pharmacies or specialised stores, must be labelled in the Slovene language on the outer packaging, or immediate packaging if outer packaging is not present.
LABELLING OF MEDICINAL PRODUCTS WITH A LABEL IN THE SLOVENE LANGUAGE
Based on provisions of indent one of paragraph five of Article 87 of the ZZdr-2, considering measures required for the protection of public health the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) may exceptionally grant an exemption to the obligation of labelling a medicinal product in the Slovene language and allow the use of packaging in the language of one of the European Union member states, in the Latin alphabet, with a label in the Slovene language and patient leaflet in the Slovene language.
Detailed requirements and conditions regarding obtaining such an exemption are described in Articles 14 and 26 of the Rules on the marking and instructions for use of medicinal products in human medicine (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 54/2014; hereinafter: the rules).
The marketing authorisation holder shall have in place a system of obligations and responsibilities for the business entities involved in such labelling, including batch release.
MEDICINAL PRODUCTS IN FOREIGN PACKAGING
Based on the provisions of indent two of paragraph five of Article 87 of the ZZdr-2 and considering the measures required for public health protection, JAZMP may exceptionally grant the entire or partial exemption from the provisions in paragraphs one and three of the ZZdr-2 in regard to medicinal products that are not intended for direct issuance to patients in pharmacies, or for medicinal products with serious issues regarding accessibility.
Detailed requirements and conditions regarding obtaining such an exemption are described in Articles 16 and 27 of the rules.