It is well known that the EU acquis divided into 35 chapters for the purposes of accession negotiations. Chapter 1 is concerned with free movement of goods, which represents one of the four fundamental freedoms of the European Union.
This project aims to assist Montenegro in the accession process by facilitating approximation and implementation of legislation in the area of free movement of goods, especially in terms of registration, marketing and consumption of medicines and medical devices.
Moreover, it focuses on enhancing institutional and operational capacities of the Institute for Medicines and Medical Devices (CInMED), as well as on improving the institution’s visibility and capacity to communicate effectively with stakeholders, such as healthcare professionals, patient associations etc. In other words, the project seeks to support CInMED in performing its statutory duties and improving the healthcare system and patients’ protection in Montenegro, particularly by ensuring compliance with EU standards relevant to Chapter 1, including for medicines and medical devices.
It is expected that this project will result in improvements in post-marketing safety of medicinal products in use (pharmacovigilance), the Medical Device Vigilance System, as well as the systems for authorisation and inspection of medicines and clinical trials in Montenegro. The project ends in July 2022.