LABELLING OF FOREIGN-LANGUAGE-LABELLED MEDICINAL PRODUCT WITH A SLOVENE LABEL ATTACHED

In accordance with the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/14) and considering measures required in the interest of public health protection, JAZMP may exceptionally allow the use of packaging in a foreign language (not Slovene) with a label in the Slovene language.

Conditions for authorisation and label use are managed in the Rules on labelling and package leaflet for medicinal products in veterinary use (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 101/09).      

Please use e-mail address v-vnos_uvoz@jazmp.si regarding applications for the use of packaging in a foreign language with a label in the Slovene language.