The Institute for Medicines and Medical Devices of Montenegro is highly dedicated to the improvement of international cooperation with numerous regulatory bodies and international organizations in the areas of its competences. This is supported by the invitation of the Pharmaceutical Inspection Cooperation Scheme – PIC/S to the congress organised in honor of the celebration of 50 years of establishment of this particularly important international association.
The influence of PIC/S is of priceless importance for conducting inspections of the manufacture and distribution of medicines, especially in terms of establishing and harmonizing legislation and standards at the international level.
The Congress was attended by the highest representatives of the European Commission, European Medicines Agency, as well as European and international regulatory bodies in the field of medicines and medical devices. On that occasion, CInMED representatives have established contacts and exchanged opinions regarding further CInMED’s path of development and joining the European family of regulators. Representatives also presented activities that were carried out with the aim of reaching European standards in the conduction of GMP and GDP inspections, i.e., supervision over the manufacture and marketing of medicines and in addition, possibilities of CInMED becoming a full member of the PIC/S even before Montenegro’s accession to the European Union were also considered.
The support of numerous international partners has been gained as a result of the participation of Institute’s representatives at this prestigious event, with a special emphasis on the support of European Medicines Agency’s (EMA) Executive Director, Ms. Emer Cooke, as well as of Mr. Paul Gustafson, PIC/S Committee Chairperson. The European Commission will in the upcoming period assess the capacity of CInMED to respond to the requirements of European standards for the conduction of inspections of the manufacture and distribution of medicines. The outcome of the positive evaluation of the European Commission will be the recognition of the findings of the CInMED Inspectorate by all member states of the European Union, as well as the acquisition of full membership in the PIC/S under the accelerated procedure.
