The Institute for Medicines and Medical Devices (CInMED) continues to reaffirm its pivotal role in strengthening national regulatory system and its harmonisation with standards of the European Union.
Over the past several weeks the Institute has been subject to inspection by the European Commission representatives within the Joint Audit Program. The aim of this comprehensive evaluation was to verify the competencies of the Institute, with a particular focus on inspection supervision and control in the manufacture and distribution of medicines, as well as the extent to which it is harmonised with European standards in the areas that are of critical significance for safety, quality and efficacy of medicines.
Operation of the Institute was assessed through 78 internationally standardised indicators, out of which 73 demonstrated full compliance, while recommendations for improvement were issued for only 5.
“Such a finding of the Commission confirms that the Institute has built strong, stable and modern regulatory system in the field of medicines, and that our small, but committed and unified team is capable of responding to highest European standards. It is particularly significant that this outcome is comparable to the ones achieved by much larger regulatory bodies of the EU Member States during similar visits and evaluations. The conclusion of the European Commission is of great importance for us – not only does it motivate us to continue with further improvements, but it also provides additional encouragement, as it clearly confirms that that all our previous efforts have been duly recognised and valued by relevant European institutions“, said Managing Director of the Institute Mrs. Snežana Mugoša, MD, MSc, PhD, spec.
As early as this week CInMED continues with activities on the European path of Montenegro. The Institute will host experts from the European Medicines Agency who will deliver training intended for EU candidate countries, with a particular focus on a specialised workshop dedicated to safety and efficacy of medicines.
For the first time Montenegro will host such an important international training in the area of medicines and regulatory standards – which is yet another recognition of the progress of our system and a confirmation that CInMED is recognised as a reliable partner in the European regulatory network.
The Institute for Medicines and Medical Devices will continue to enhance its capacities in line with the European standards, with a clear objective of providing quality, safe and effective medicines to citizens of Montenegro and of contributing to the single European market and stronger international cooperation.
