Recognizing the importance of harmonization of regulatory framework of the European Union, as well as of the adoption of European standards and models of efficient regulation in the field of medicines and medical devices, the Institute for Medicines and Medical Devices of Montenegro has undertaken numerous activities in the area of international cooperation and European integration in the previous period, with the aim to improve public health.
Established cooperation with the European Medicines Agency (EMA) resulted in an invitation for the Institute’s experts to become part of the expert training conducted by EMA. Namely, the eight-member delegation of the Institute for Medicines and Medical Devices, led by the Managing Director, Ms. Snežana Mugoša, MD, MSc, PhD, spec., and Deputy Managing Director, Ms. Mira Kontić, MSc., are staying at the EMA in Amsterdam this week, where they attend high level expert trainings in the field of assessment of quality, safety and efficacy of medicines, as well as the assessment of compliance with the guidelines of good manufacturing and good distribution practice of medicines.
Cooperation between institutions, especially with the EMA, leads to the phenomenon of mentoring and networking, which is an important factor for Montenegrin institutions on the European path, as well as the establishment of partnerships and creation of strong ties among European regulators.
As the European Union Member States are increasingly open to cooperation with Montenegro as a candidate country for European Union membership, numerous trainings and participation in working groups and projects financed by the European Union are now available. Institute for Medicines and Medical Devices of Montenegro, as a regulatory body in a small country, highly values this type of assistance and strives to use every opportunity to learn from the best and continuously improve its own capacities.
Through participation in the work of the EMA, Montenegrin Institute had the opportunity to propose areas and manners of cooperation for the next two years, which is expected to be approved by the European Commission by the end of this year. Through this programme, the Institute will have the opportunity to directly participate in the work of numerous working groups and committees within the EMA and thereby contribute to the creation of future regulatory framework in the area of medicines at the level of the European Union.