Advanced therapy medicinal products prepared on a non-routine basis

The field of advanced therapy medicinal products prepared on a non-routine in the Republic of Slovenia is determined by the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/14) with Chapter V, with Articles from 71 to 86.
In accordance with Article 71 of ZZdr-2, an advanced therapy medicinal product prepared on a non-routine basis for human and veterinary use may be prepared by a business entity from the Republic of Slovenia that holds an authorisation from the JAZMP for the preparation of an advanced therapy medicinal product prepared on a non-routine basis for human and veterinary use in accordance with the quality standards or preparation conditions laid down by ZZdr-2 within the scope of the issued authorisation.