The Institute for Medicines and Medical Devices of Montenegro (CInMED) reminds the public that the composition, manufacture, distribution and administration of all vaccines in Montenegro are subject to rigorous control, in line with the highest European and international standards. Vaccination is one of the most effective measures for preventing serious infectious diseases, making vaccines medicinal products of particular importance for protecting both individual and public health.
As vaccines are administered predominantly to healthy individuals, including children, particular attention is paid to their quality, safety and efficacy at every stage – from development and manufacture, through control and distribution, to administration. Vaccines are composed of substances whose properties and effects are well known and which comply with internationally recognised quality standards. These substances are present in vaccines in quantities that have been demonstrated to be safe for human health. Prior to the issuance of marketing authorisation for a medicinal product, safety and efficacy of a vaccine must be confirmed through extensive and long-term laboratory, preclinical and clinical studies.
The vaccines placed on the market in Montenegro are also used in European Union Member States and neighbouring countries. Every batch of vaccine imported into Montenegro must be accompanied by a manufacturer’s certificate, as well as an additional certificate issued by an independent accredited laboratory confirming that the vaccine meets required quality standards. The import, storage and distribution of vaccines are likewise carried out in strict compliance with prescribed standards and are subject to continuous inspection. CInMED continuously monitors safety of vaccines, as well as that of other medicinal products on the market, through active participation in the international system for monitoring safety of medicinal products and cooperation with relevant international institutions. In addition, safety of vaccines on the market is monitored through the immunisation surveillance system jointly implemented by CInMED and the Institute of Public Health. The purpose of this system is to ensure that any potential concern related to vaccine administration is identified as early as possible and that the competent institutions respond in a timely and appropriate manner.
As with other medicinal products, adverse reactions may occur following vaccination. These are most commonly mild and transient (redness, swelling and pain at the injection site, fever, fatigue and irritability), while serious adverse reactions are extremely rare. At the same time, diseases that can be prevented through vaccination carry an incomparably greater risk of serious and potentially fatal complications. The benefits of vaccination therefore far outweigh the potential risks. Extensive scientific evidence confirms that vaccines do not cause autism or developmental disorders.
Reliable and verified information on vaccines authorised in Montenegro is available on the CInMED portal (www.cinmed.me), through the Register of Medicinal Products for Human Use. As part of the procedure for marketing authorisation issuance, the Summary of Product Characteristics, intended for healthcare professionals, and the Package Leaflet, intended for patients, are approved. These documents contain important information on the composition of the vaccine, its mechanism of action, approved indications and possible adverse reactions.
CInMED encourages citizens to make decisions concerning their own health and the health of their children on the basis of reliable, expert and evidence-based information, in consultation with their primary care physician and paediatrician.
