Please be informed that document Manner of submitting application and documentation for variations is now published on the CInMED website, along with an updated application form for notification/approval of a variation. Marketing authorization holders are asked to follow the published instructions and to use the updated application form when preparing and submitting documentation for variations.

Report on the results of spontaneous reporting of adverse reactions to medicines in 2023

 

Please be informed that the Report on the results of spontaneous reporting of adverse reactions to medicines in 2023 has been published on the portal of the Institute in the section Pharmacovigilance/Annual reports.

 

The published report contains the analysis of adverse reactions to medicines reports sent to the Institute for medicines and medical devices during 2023, a brief overview of the most important regulatory measures taken by CInMED during the previous year, as well as information on the educational activities conducted with the aim of the improvement of the pharmacovigilance system in Montenegro.

 

Compared to the previous year, in 2023 there was a significant increase in total number of submitted reports which is a result of greater involvement of healthcare professionals in the system of monitoring of the use of medicines. Bigger number of reported adverse reactions is primarily the result of the SMART Pharmacist – Therapy Management Process project, which was launched in September 2023 and organized by CInMED. Its goal was to educate and improve the competencies of pharmacists as the most accessible providers of health care, and the majority of adverse reactions to medicines reports received in 2023 were submitted by pharmacists who participated in the mentioned project. Majority of submitted reports related to medicines that act on the cardiovascular system, which is expected, considering that this group of medicines is the one most often used in Montenegro. When it comes to adverse reactions, majority of reported reactions related to disorders of the digestive system and reactions on the skin in the form of rashes and redness. On this occasion, CInMED would like to remind healthcare professionals and patients that during summer months it is necessary to pay special attention to the fact that many medicines (antibiotics, diuretics, pain relief medicines, retinoids…) can increase the skin’s sensitivity to UV rays and cause photosensitivity reactions. When prescribing and dispensing these medicines, patients should be warned to read the package leaflets of a medicine, as well as to take the necessary measures to protect the skin from UV rays, so as to prevent photosensitivity reactions.

 

CInMED would like to thank all healthcare professionals and patients that by reporting adverse reactions contribute to monitoring of the use of medicines in Montenegro.