According to the Article 87 of the Medicinal Products Act (Off. Gazette of the Republic of Slovenia, No. 17/2014 and 66/2019; hereinafter: ZZdr-2), medicinal products which are 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 which are intended 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.
JAZMP can, on the basis of a report on the consumption of the medicine in the previous year or a plan for the consumption of the medicine for the calendar year, which does not exceed 3000 pieces or 40 000 euros of annual turnover, or both, allow the re-labelling of the packaging of the medicine which is in the language of one of the member states of the European Union, in the Latin alphabet, with a label in Slovenian language and PIL in Slovene language.
In this case, the name of the medicine on the packaging in the language of one of the member states of the European Union must be the same as the name of the medicine licensed for sale in the Republic of Slovenia. If the name of the medicinal product is consisted of the international non-proprietary name (INN) or other common name of the active substance followed by the brand name or the name of the marketing authorization holder, all language versions of the international non-proprietary name (INN) or other generic name of the active substance are considered the same name.
The application for re-labelling of the medicinal product with a marketing authorization with the labels is submitted to the JAZMP each year. The approval is issued for each calendar year, regardless of the date of the application.
Detailed requirements and conditions regarding obtaining such exemption are described in Articles 14 and 26 of the Rules on the marking and instructions for use of medicinal products in human medicine (Off. Gazette of the Republic of Slovenia, No. 54/2014).
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 (dispensing of the medicine is H or ZZ), or for medicinal products with serious issues regarding accessibility.
Detailed requirements and conditions regarding obtaining such exemption are described in Articles 16 and 27 of the rules.
Source: JAZMP web page, the Medicinal Products Act (Off. Gaz. Of RS No. 17/14 and 66/19) and Rules on the marking and instructions for use of medicinal products in human medicine (Off. Gazette of the Republic of Slovenia, No. 54/2014)