Ana Lakobrija

SmPC, PIL, Labeling •Preparing the Summary of Product Characteristics of drug, Package Leaflet and Labelling, •establishment and maintenance of administrative records; •organizing the meetings with the aplicant regarding the submitted documents; •organization and preparation of the commision for placing on market the human, traditional and homeopathic medicines;

assessment of: - the documentation on the quality of the immunological drug for veterinary use in the procedure for obtaining marketing authorization; - documentation on the safety and efficacy of the immunological drug for veterinary use in the procedure for obtaining marketing authorization; - periodic safety update reports ( PSUR ); - documentation for the Summary of Product Characteristics of drug, Package Leaflet, •evaluation of the documentation for the amendment of the license (variations ) ;