Pharmacovigilance

Welcome to the section of the Medicines and Medical Devices Agency of Serbia (ALIMS) website that deals with PHARMACOVIGILANCE.

No medicine is entirely safe. In other words, no medicine is risk free. Although many of the risks are known at the time of licensing a medicine, some information on its safety profile comes to light later, after marketing a medicine, as medicine usage increase.

Before a medicine is marketed, information on its safety is limited to its use in clinical trials under specific, ideal circumstances that do not necessarily reflect the way the medicines are used in daily routine health practice, once they are marketed. Despite the extensive pre-marketing research, non-clinical trials in animals and clinical trials in humans, some adverse reactions may not be seen until a very large number of people have received the medicine.

Therefore it is very important that the safety of all medicines is monitored throughout their marketed life – known as pharmacovigilance.

The ultimate goal of pharmacovigilance is to protect public health by putting patient safety in main focus. Therefore, pharmacovigilance is considered an essential part of medicines regulation.
One of the assigned affairs performed by the ALIMS is establishment, continuous maintenance and improvement of the national pharmacovigilance system in Serbia. System should enable safety signal detection, risk identification, characterisation, assessment, minimisation, communication and prevention in order to provide the best possible benefit/risk ratio of medicines in daily practice and promote rational and safe use of medicines. Those pharmacovigilance activities ALIMS conducts by its National Pharmacovigilance Centre (NPC).

As crucial element of public health protection, pharmacovigilance represents the most important ALIMS`s affair for current and future period. Working together with all parties in the field of pharmacovigilance, the ALIMS wants to contribute to strengthening of responsible, authoritative and confident pharmacovigilance system and medicines regulatory system, in order to improve patient safety.