Alims ALIMS Vlada Republike Srbije
ALIMS
Rules for medical devices

Rules for medical devices

Rules of conditions for the import of medicines and medical devices which do not have the marketing authorization "Official gazette of RS", Nos. 37/08 and 45/08

Rulebook on the Contents of the Application, and/or Documentation on the Approval of Clinical Trials for Medicines and Medical Devices, as well as the Method of Implementation for Clinical Trials of Medicines and Medical Devices ("Official Gazette of RS", No. 64/2011)

Rulebook on the method of reporting, collecting and monitoring adverse reactions to medicines ("Official Gazette of RS", No. 64/2011)

     
EudraLex - The Rules Governing Medicinal Products in the European Union, Volume 4
EU Guidelines to Good Manufacturing Practice - Medicinal Products for Human and Veterinary Use
 
European Medicines Agency // ICH Topic E 6 (R1) Guideline for Good Clinical Practice - NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE  
ICH HARMONISED TRIPARTITE GUIDELINE // CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION - E11  
     
 Rules of the contents of the marketing authorization for a medical device ("The Official Gazette of the Republic of Serbia" 99/2006 )  Pravilnik o postupku i uslovima za dobijanje dozvole za stavljanje leka u promet  Pravilnik o postupku i uslovima za dobijanje dozvole za stavljanje leka u promet
Rules of the procedure and conditions for obtaining the marketing authorization for a medical device ("The Official Gazette of the Republic of Serbia" 102/2006 ) Pravilnik o postupku i uslovima za dobijanje dozvole za stavljanje leka u promet Pravilnik o postupku i uslovima za dobijanje dozvole za stavljanje leka u promet