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.
Please be informed that the new CInMED portal has been created. In the next period, we will work on content migration, so certain non-functionalities may be expected. Until the new portal is fully functional, the old one will be available on the link: https://secure.cinmed.me/Portal
With the purpose of improvement of functionality of the portal and availability of information, we encourage CInMED portal users to send all their comments, suggestions, questions and doubts to the e-mail address [email protected].
MEDI-THEFT 2nd Newsletter provides information about the realized project activities, further plans, principles of operation of the MEDI-THEFT platform, and featuring a valuable interview by one of the founders of the Crime&tech company, Dr. Marco Dugato (UNICAT).
The Project foresees the publication of two Newsletters per year, to keep stakeholders and the general public updated on the most important news, the relevant progress and all the planned or attended events.
Announcements and additional information can be found on the official MEDI-THEFT |
7th #MedSafetyWeek has just started! From today until the end of the week we will be among 82 countries that participate in the campaign organized through social networks and led by WHO Collaborating Centre for International Drug Monitoring – Uppsala Monitoring Centre (UMC). The campaign is supported by members of Heads of Medicines Agencies (HMA) and International Coalition of Medicines Regulatory Authorities (ICMRA). Theme of this year’s campaign is “How patients and healthcare professionals make safety work” and it will focus on how important role of patients and healthcare professionals is for safe use of medicines.
Medicines are safe and effective, however, in some patients they can cause adverse reactions. Competent regulatory institutions in the field of medicines, in Montenegro it is CInMED, establish a system for continuous monitoring of medicines safety, with the aim to collect new information on adverse reactions that are already known and also detect entirely new ones in a timely manner.
Adverse reactions reporting system (Reporting scheme), established by CInMED, detects, collects, analyzes reports of suspected adverse reactions, with the aim of preventing their occurrence in other patients.
Every report submitted by a patient, or a healthcare professional is significant, as it contributes to creating a real picture of safety and efficacy of the medicine. If necessary, in order to protect patients, CInMED implements adequate regulatory measures that can contribute to improvement of prescribing practices and better outcome of treatments.
We hope that this campaign will encourage everyone to report suspected adverse reactions, as by doing so, they contribute to expansion of knowledge about medicines, which, in the end, makes them safer for all of us.
Detailed information on how to report a suspected adverse reaction is available in the section Pharmacovigilance/How to report an adverse reactions to medicines.
Materials used in the campaign are available on CInMED Instagram account and Youtube channel.
Institute for Medicines and Medical Devices (CInMED) participates in global campaign led by World Health Organization (WHO) which celebrates the Antimicrobial Awareness Week every year from 18 to 24 November. This year, the theme of the campaign is “Preventing Antimicrobial Resistance Together”.
Antimicrobial resistance is a resistance of microorganisms (bacteria, viruses, parasites and fungi) to antimicrobial medicines, while the resistance of bacteria to the action of antibiotics is referred to as an antibiotic resistance. Excessive, improper and unnecessary use of antibiotics in animals and humans favors the development of antibiotic resistance, which represents a global problem and a serious danger to human health. The number of infections cauesed by bacteria resistant to the action of antibiotics is on the rise, while the number of new available antibiotics is not large, which increases the threat that antibiotic resistance represents to our health.
Due to mentioned reasons, we encourage all healthcare professionals and patients to use antibiotics rationally and responsibly:
- antibiotics are used to treat bacterial infections, but not infections caused by viruses
- antibiotics do not reduce fever
- antibiotics are prescription medicines
- antibiotics should be used only when prescribed by a doctor, at regular intervals, for as long as the doctor has prescribed.
Educational material prepared by CInMED on this occasion is available here.
First annual Conference of the Institute for Medicines and Medical Devices of Montenegro entitled “European perspective of CInMED – to achieve mutual goal through cooperation and partnership” took place from 1 to 3 December 2022 in CUE Hotel in Podgorica.
During the conference, new competences of the Institute were presented, along with current development in the field of medical devices legislation and trainings in the area of Good Distribution Practice Guidelines (GDP), Good Pharmacovigilance Practice Guidelines (GVP) and the protection system against falsified and substandard medicines were organized as well. In cooperation with colleagues from the Italian Medicines Agency, we presented the MEDI-THEFT project that the Institute has been implementing in cooperation with EU partners, which aims to prevent stolen and falsified medicines from entering into legal supply chain.
Conference was concluded with a round table entitled “To achieve mutual goals through partnership”, which was entirely devoted to questions and comments of participants.
It was concluded that the organization of such events was the best manner to exchange knowledge and experience and discuss issues of importance in the field of medicines and medical devices, but also to establish contacts and good partnership relations that would result in further positive steps in the business operation of the Institute and its clients and associates.
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.