Regarding an increased interest in the composition of vaccines lately, as well as in their safety and efficacy, the Institute for medicines and medical devices (CInMED) would like to remind the public that the composition, manufacturing, distribution and use of all vaccines in Montenegro are strictly controlled, in accordance with the highest European and international standards.
Precisely due to the fact that vaccines are administered to healthy people, most often to children, with the aim of protecting against infectious diseases, special attention is paid to respecting the highest standards at every step of their manufacturing, distribution and use. Substances entering into the composition of vaccines have a known effect, meet international quality standards and are present in quantities that are proven to have no harmful effect on human health. Prior to placing on the market, the efficacy and safety of the vaccine must be proven through numerous non-clinical and clinical studies.
Vaccines marketed in Montenegro are used in European Union member states and neighboring countries, but every batch of the vaccine (regardless of whether it obtained marketing authorisation in Montenegro or is marketed on the basis of approval of the „emergency import“), when importing into Montenegro, must be accompanied by the manufacturer’s certificate, as well as additional certificate from one of independent accredited laboratories, which confirms required quality. CInMED monitors safe use of vaccines, as well as other medicines that are on the market, through active participation and international cooperation within the international program for safe use of medicines monitoring. Additionally, safety of vaccines on the market is closely monitored through the immunization monitoring system, which is jointly carried out by CInMED and the Institute for Public Health, so that any potential issue related to the use of vaccines is identified as early as possible, and reaction of the institutions is timely and adequate.
Register of medicines on CInMED portal allows healthcare professionals and patients to find accurate and reliable information about vaccines authorised in Montenegro. The Summary of product characteristics (intended for healthcare professionals) and the Package leaflet (intended for patients) are also available and they are approved by CInMED within the marketing authorisation issuance procedure and contain information about the composition of the medicine, its mode of action, approved indications, as well as possible adverse reactions.
CInMED calls on patients to make decisions on their own health and health of their children on the basis of reliable and evidence-based information about vaccines, in cooperation with their chosen doctor and pediatrician.
