Alims ALiMS Vlada Republike Srbije
ALiMS
FUNCTION OF THE AGENCY

The Agency shall be in charge of:

  • issuing marketing authorizations for medicinal products and medical devices,

  • performing laboratory quality control of medicinal products and medical devices,

  • issuing authorizations for clinical trials of medicinal products and medical devices and controlling the conduct of clinical trials,

  • monitoring adverse reactions of medicinal products and medical devices,

  • issuing certificates on compliance with guidelines on Good Manufacturing Practice, Good Laboratory Practice, and Good Clinical Practice in clinical trials of medicinal products and medical devices,

  • authorizing the import of non-registered medicinal products and medical devices for the treatment of a particular patient or group of patients and medicinal products and medical devices for scientific research,

  • classification of medicinal products and medical devices,

  • collecting and processing statistical data on trade and consumption of medicinal products and medical devices,

  • providing information and promotion of rational use of medicinal products and medical devices,

  • integration into international networks of information on medicinal products and medical devices and integration into international agencies associationsi

  • other tasks in accordance with this Law