Risk Minimisation Communication in Non-EU Countries

Abstract

Communicating risk and safety information to patients and healthcare professionals is a public health and our ethical responsibility. Risk communication is central to risk management strategy of pharmaceutical companies. This way will be achieved the objectives of pharmacovigilance in terms of promoting the rational, safe and effective use of medicinal products. It is imperative in the pharmaceutical sector and industry, preventing occurrence and harm of adverse drug and medical reactions, minimising risks, which leads to protection of the patients and public health. In this article we will elaborate the risk and risk minimisation communication. Countries of interest are North Macedonia, Serbia, Bosnia and Herzegovina, Montenegro, Albania and Kosovo, making comparison with the European Union (EU). Risk minimisation communication should enhance awareness of patients/caregivers on careful monitoring, early detection and steps to be taken in order to achieve the safe use of medicinal products. The objectives of ensuring the safe use of the medicinal product and minimising risks, including their adverse health outcomes are facilitated by risk minimisation measures (RMMs). We will give an in depth look at regulation compliance from the markets of interest within country-specific environments.