Adverse reactions to medicines reporting
According to Law on Medicines healthcare professionals are obliged to report each suspected adverse reaction to the medicine to the Institute for Medicines and Medical Devices (CInMED). Healthcare professionals can report adverse reaction to the Institute directly, or through the representative of medicine manufacturer (marketing authorization holder) in Montenegro. Adverse reactions to the vaccines are monitored by CInMED and the Institute for Public Health of Montenegro.
Suspected adverse reactions to medicines may be reported to CInMED via online reporting form, which you can access by clicking, or scanning the QR code below.
Online reporting form is suitable for completing using a mobile phone and the application now works offline also. In that case, the data that you enter will be saved and sent automatically to the Institute once your device gets connected to the Internet. You can save the application on your mobile phone, following this Instruction.
Reporting of suspected adverse drug reaction may also be done by completing Adverse reaction reporting form (updated on 24.11.2020., document in Montenegrin), taking into account Notes important for completing the form (document in Montenegrin).
Reporting of a suspected adverse event following immunisation may be done by completing the Adverse Reaction Reporting Form (updated on 2.3.2023. (document in Montenegrin)), taking into account the Notes important for completing the form (document in Montenegrin).
Patients may report adverse reactions to medicines/vaccines to CInMED by completing Adverse reaction reporting for patients (updated 15.10.2021.)
Fulfilled reporting form can be submitted to the Institute in one of the following manners:
By Post (or in person):
Institute za ljekove i medicinska sredstva Crne Gore
Bul. Ivana Crnojevića 64A
81 000 Podgorica
By phone:
+382 (20) 310 280
+382 (20) 310 281
+382 (20) 310 580
By fax:
+382 (20) 310 581
By e-mail:
If you are a chosen doctor in primary healthcare/general hospital/Clinical center of Montenegro, pharmacist in AU Montefarm, you can report suspected adverse reaction to the medicine/vaccine to the Institute directly through primary healthcare/general hospital information system.
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