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.
Institute for Medicines and Medical Devices (CInMED) was a participant of the 10th jubilee Medical Conference entitled “Current affairs in the areas of healthcare, medicine and pharmacy”, traditionally organized by the journal “Medical CG”. The conference was held from 1st to 4th June in Ulcinj.
Certificates of gratitude for contribution and support were presented on the occasion of marking the decade of organizing the Medical Conference, and one of them was presented also to CInMED Managing Director, Ms. Snežana Mugoša, MD, MSc, PhD, spec. On behalf of CInMED, she expressed gratitude for successful long-lasting cooperation and friendship and acknowledged immense effort, work, as well as responsible and attentive attitude with the aim of contribution to development of the health system, education and awareness of healthcare professionals workers, as well as patients.
“Our long-lasting and reliable partnership is based on deep understanding and common principles of solidarity and humanity, as our institution also strives to be an example and leader in corporate social responsibility and charity“, said Ms. Mugoša.
Round table was organized on the first day of the Conference with the aim of discussing the importance of revising the List of medicines, with an emphasis on savings and greater availability of medicines, then the challenges in the continuous supply of medicines and medical devices, as well as public procurement procedures and also criteria for conducting negotiations and determining prices of medicines. On behalf of the Institute for Medicines and Medical Devices (CInMED), the participant of the round table was the Managing Director, Ms. Mugoša.
On that occasion, she presented results of CInMED in the previous year and a half which are an extraordinary foundation for successful contribution of CInMED within the aforementioned areas of importance for the health system of Montenegro. She also emphasized the importance of synergistic approach of all competent institutions in achieving exceptional results in all segments of public health.
CInMED session moderated by Ms. Mugoša was organised on the third day of the Conference. It gathered a large number of participants and aroused great interest of attendees.
During this session, an analysis of medicines consumption in the period from 2017 to 2021 was presented, and Ms. Lidija Čizmović, PharmD, spec., additionally presented the data on the consumption of medicines for 2022. Ms. Anja Glušica, PharmD, spoke about similarities and differences between generic and original medicines and pointed out the issue with regard to knowledge, perception and beliefs of patients, including healthcare professionals, when it comes to generic medicines. A guest from the Agency for Medicinal Products and Medical Devices of Croatia, Ms. Sanja Matić, PharmD, spec., spoke about the reference-pricing model for medicines in the EU. She described different reference-pricing models in the EU and highlighted the advantages of this methodology.
The fourth day of the Conference, Ms. Maja Lisičić, PharmD, spec., gave a presentation about biosimilar medicines within which the regulatory aspects of biosimilar medicines and interchangeability were discussed in particular.
Managing Director of the Institute for Medicines and Medical Devices (CInMED), Ms. Snežana Mugoša, MD, MSc, PhD, spec., and Deputy Managing Director, Ms. Mira Kontić, LL.M., are attending the 59th meeting of EMACOLEX at the invitation of the European Medicines Agency. The meeting is being held from April 20 to 21 in Uppsala, Sweden.
EMACOLEX (European Medicines Agencies Co-operation of Legal and Legislative Issues) is a body of the European Medicines Agency, comprised of lawyers from the European Union Member States that are responsible for the development and implementation of European regulations and standards. EMACOLEX meetings are organised with a purpose of discussion among its representatives in order to reach an agreement on uniform principles and legal positions that will be applied throughout the European regulatory network.
CInMED representatives see this meeting as an ideal opportunity to exchange opinions on legal matters and exchange experiences in solving issues of national interest, as in this manner perspectives are broadened with regard to systematic regulation of regulatory conditions on the market of medicines and medical devices.
Participation in the work of the most important legal body of the EU, even before Montenegro becomes a member state, is of great importance for further improvement of CInMED’s work.
“We need to continue finding ways to cooperate and participate in the work of European bodies. By doing so, we build the progress of institutions and position Montenegro as an equal partner in the family of European nations. This is the only way we can respond to real challenges we face, especially when it comes to contributing to the establishment of the rule of law and building a predictable and reliable legal framework”, CInMED said.
Institute for Medicines and Medical Devices of Montenegro (CInMED) continues to expand the network of its international partners in the field of medical devices. At the invitation of the European Commission, the Managing Director of CInMED, MD, MSc, PhD, spec. Snežana Mugoša and Deputy Managing Director, LL. M. Mira Kontić, are attending the official meeting of the International Medical Devices Regulators Forum (IMDRF), which is being held on March 27 and 28 in Brussels.
IMDRF is an international organization of medical devices regulators united with a purpose of creating a strong and single regulatory framework and promoting effective models for responding to growing challenges for public health and patient safety protection. In addition to the highest representatives of the European Commission, the meeting of this exceptionally important international association is attended by representatives of all IMDRF member states, i.e. the most influential European and world regulators, such as the medicines agencies of the USA, Brazil, Canada, Great Britain, Japan, China, Australia, etc.
CInMED representatives used this opportunity to make significant contacts and exchange opinions on further development path of CInMED. After the top level talks, the chairman of the IMDRF, Dr. Andrzej Rys, called for the Institute for Medicines and Medical Devices of Montenegro to become a full member of the family of international regulators in the field of medical devices. CInMED representatives expressed their gratitude for the invitation and emphasized that they would take necessary steps to gain membership in this international organization as soon as possible. In this manner, CInMED would have the opportunity to contribute and influence the regulation and harmonization of standards in this field at the international level.
The cooperation of regulatory institutions and representatives of manufacturers and distributors of medical devices through IMDRF enables the development, certification and monitoring of medical devices to be viewed from a global perspective, as well as the improvement of the regulatory response to challenges brought by innovations and new technologies.
“Achievements in the field of medical devices, i.e. the introduction of extremely sophisticated new technologies into the treatment of the most complex diseases, move the boundaries of conventional medicine. Therefore, we must broaden our horizons and be ready for the future that scientific and technological development brings with it, but also introduce measures that ensure the highest standard of protection for our patients”, pointed out the Managing Director of CInMED, MD, MSc, PhD, spec. Snežana Mugoša.
