We hereby inform you that the Report on the results of spontaneous reporting of adverse reactions to medicines in 2025 has been published on the Institute’s website in the section Pharmacovigilance/Annual Reports.
The Report provides an analysis of reports of suspected adverse medicines reactions submitted to the Institute for Medicines and Medical Devices (CInMED) during 2025, a brief overview of the most significant regulatory measures implemented by CInMED throughout the previous year, as well as information on educational activities conducted to support further development of the pharmacovigilance system in Montenegro.
Each report of a suspected adverse reaction to a medicine may contribute to the assessment of the safety profile of the medicine and its continued use. Particular attention should be paid to monitoring safety of newly authorised medicines, and adverse reactions described in scientific publications and other literature should also be reported. Delayed reporting or failure to communicate important safety information relating to medicines on the market may hinder timely detection of potential safety concerns and consequently compromise patient safety.
CInMED reminds healthcare professionals that each adverse medicine reaction report submitted is awarded a corresponding number of credits during the licence renewal process conducted by the Medical Chamber and the Pharmaceutical Chamber of Montenegro, providing an additional incentive for their active participation in pharmacovigilance activities. The integration of the CInMED information system with the information system of the Clinical Centre of Montenegro, together with improvements to the online reporting application accessible through the CInMED website, has significantly facilitated the submission of reports. As a result of these measures, as well as ongoing educational and awareness-raising activities, we expect the reporting of adverse medicine reactions to become an integral part of the routine clinical practice of an increasing number of healthcare professionals in Montenegro. CInMED would like to express gratitude to all healthcare professionals and patients who contribute to the pharmacovigilance system by reporting suspected adverse medicine reactions and thereby support safe use of medicines.
