IMPORT OR ENTRY OF MEDICINAL PRODUCTS WITHOUT MARKETING AUTHORISATION
The import or entry of medicinal products without marketing authorisation in the Republic of Slovenia is only possible if the applicant has a valid import or entry permit granted by JAZMP in accordance with Paragraph 3 of Article 20 of the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/2014 and 66/2019; hereinafter: ZZdr-2) and the Rules on the conditions, method and procedure for the acquisition of a permit for the import or entry of medicinal products for human use (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 65/2012).
Obtaining a permit for the import or entry of medicinal products without marketing authorisation
A permit for the import or entry of medicinal products without marketing authorisation will be issued by JAZMP:
- if required for individual emergency treatment or at the request of the attending physician and in the opinion of the responsible person of the hospital or institute, on his or her personal responsibility, for the needs of one or more individual patients;
- for medicinal products without marketing authorisation listed among the essential or indispensable medicinal products (under Article 17 of ZZdr-2) when no equivalent medicinal product with marketing authorisation has been placed on the market or is not available on the market in the Republic of Slovenia;
- for medicinal products in exceptional cases, or for other reasons that are in the interest of public health protection.
Applications for obtaining a permit for the import or entry of medicinal products without marketing authorisation may be submitted by wholesalers of medicinal products who have wholesale authorisation for the of medicinal products issued by JAZMP or who have obtained such authorisation in another EU Member State and notified JAZMP that it intends to perform these activities in the Republic of Slovenia.
The import of medicinal products (from third countries) may be carried out by manufacturing authorisation holders whose manufacturing authorisation includes the import.
1. Obtaining a permit for the import or entry of a medicinal product in the case of individual emergency treatment
A written application pursuant to Article 5 and 6 of the Rules on the conditions, method and procedure for the acquisition of a permit for the import or entry of medicinal products for human use (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 65/2012) shall be submitted to JAZMP on the application form Obr. 613-03 (Slovenian language only) with all requested documents enclosed (including medical justification for import of medicinal product by competent clinic Obr. 616-02 – Slovenian language only).
2. Obtaining a permit for the import or entry of medicinal products listed among the essential or indispensable medicinal products
A written application pursuant to Article 7 and 8 of the Rules on the conditions, method and procedure for the acquisition of a permit for the import or entry of medicinal products for human use (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 65/2012) shall be submitted to JAZMP on the application form Obr. 614-03 (Slovenian language only) with all requested documents enclosed.
3. Obtaining a permit for the import or entry of medicinal products in exceptional cases, or for other reasons that are in the interest of public health protection
A written application pursuant to Article 9 and 10 of the Rules on the conditions, method and procedure for the acquisition of a permit for the import or entry of medicinal products for human use (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 65/2012) shall be submitted to JAZMP on the application form Obr. 615-03 (Slovenian language only) with all requested documents enclosed (including medical justification for import of medicinal product by competent clinic Obr. 616-02 – Slovenian language only).
