ORDER no. 1018 of 3 September 2014 on approval of the conditions for authorisation of the use of a medicinal product for human use to be available for use in last-resort treatments, in line with the provisions of Art. 83 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, version updated in February download document …

APPLICATION FOR AUTHORISATION OF THE USE OF A MEDICINAL PRODUCT IN LAST-RESORT TREATMENTS – PHYSICIANS download document … download document …

APPLICATION FOR AUTHORISATION OF THE USE OF A MEDICINAL PRODUCT IN LAST-RESORT TREATMENTS – MANUFACTURERS download document … download document …

SHEET FOR SPONTANEOUS REPORTING OF ADVERSE REACTIONS TO MEDICINAL PRODUCTS USED IN LAST-RESORT TREATMENTS download document …

Log of approved last-resort treatments download document …