MARKETING AUTHORISATION

Legislation of the European Union and Slovenian legislation determine that each medicinal product for veterinary use must obtain marketing authorisation before it is marketed. In accordance with the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/2014), a medicinal product is any substance or a combination of substances presented as having properties for treating or preventing disease in human beings or animals. medicinal product is also any substance or a combination of substances that may be used in humans or animals, and is administered to humans or animals, in order to establish a diagnosis or to restore, correct or modify physiological functions by exerting pharmacological, immunological or metabolic action, or to provide diagnosis.

Medicinal products for veterinary use which are marketed in the Republic of Slovenia must have a marketing authorisation. Marketing authorisation for the medicinal product may be obtained through different procedures:

National procedure

Mutual recognition procedure

Decentralised procedure

Centralised procedure

Detailed conditions, form, and content of the application and documentation in the procedures are set in the Rules on marketing authorisation with the medicinal product in veterinary use (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 16/11).

Information on procedures for obtaining marketing authorisation are accessible in Notice to Applicants, Chapter 1 of Volume 6A.

Medicinal products for veterinary use must also be appropriately labelled in accordance with the Rules on the labelling and package leaflet of the medicinal product for veterinary use (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 101/09).

Forms are available here.

Please follow the rules regarding the fees in the procedure.