Medicines and Medical Devices Agency of Serbia (ALIMS) may determine the list of medicines with issued marketing authorization, which are labelled with special signs for intensive monitoring of their safety profile. This list was created as one of the planned pharmacovigilance activities carried out by ALIMS in order to collect as much data as possible to upgrade the knowledge and improve understanding of the safety profile of medicines.
The list of medicines under intensive monitoring is primarily intended for healthcare professionals to increase their awareness and attention in the monitoring of medicines from the list and to report to ALIMS any suspected adverse reaction related to their administration. ALIMS updates and publishes this list on its website.
Why is the list of medicines under intensive monitoring necessary?
Before a medicine is placed on the market, information on its safety is limited since it originates from its use in clinical trials under specific conditions which do not necessarily reflect the manner of its administration in day-to-day medical practice once the medicine is marketed. Clinical trials include a small number of specifically chosen patients to whom the medicine is to be administered in a relatively short period of time. Thus, the patients participating in the clinical trial might not completely represent all profiles of patients who will receive the medicine after it is placed on the market. Despite the comprehensive pre-marketing trials, certain adverse reactions cannot be recorded unless a large number of patients had been treated with the medicine, i.e. before the physicians start prescribing the marketed medicine to patients (see section “How we monitor the safety of registered medicines”).
Subsequent up-to-date lists in the first part shall include a list of medicines that were added to or removed from the previous list. You will be notified of the publication of the first and following lists in a timely manner through the ALIMS website, application “Newsletter” and ALIMS bulletin “Pharmacovigilance”.