We would like to inform all marketing authorisation holders and wholesale authorisation holders that the Decree on the criteria of setting maximum prices of medicines (“Official Gazette of Montenegro” No 130/21 and 9/22) has been amended and that the Amendment to it was published on 7 March 2024 in the “Official Gazette of Montenegro” on 7 March 2024.

 

Previously set maximum prices of medicines are required to be aligned due to the change of reference countries, as well as the prices of medicines in them.

 

CInMED will start receiving the applications for setting/alignment of maximum prices of medicines and the required documentation when the Decree enters into force, i.e. on 15 March 2024. It is necessary to submit the required documentation along with application, in line with the Instruction on the manner of submitting application and documentation for setting/alignment of maximum price of a medicine, that is available on the CInMED portal in the section Human medicines/Maximum prices of medicines/Instructions, or here.

 

The deadline for submitting the documentation is 90 days.

Please be informed that the Rulebook on more detailed conditions for the issuance of the import authorisation for a medicine that does not have the marketing authorisation has been published on the CInMED portal in the section Legislation/Medicines/Human medicines (“Official Gazette of Montenegro” No 19/24 from 5 March 2024). It will enter into force on 13 March 2024.

Based on the recommendations of the European Medicines Agency (EMA), the marketing authorisation holders for medicines containing pseudoephedrine, in cooperation with the Institute for Medicines and Medical Devices, have informed healthcare professionals about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) for medicines containing pseudoephedrine. In Montenegro, there are several medicines from different manufacturers that contain pseudoephedrine in combination with other active substances, and their use is approved for the treatment of cold and flu symptoms or allergic rhinitis. In the future, these medicines are not to be used in patients with high blood pressure that is severe or uncontrolled, as well as in patients with severe kidney disease, as these conditions increase the risk of the above-mentioned syndromes. Symptoms of PRES and RCVS include severe headache with a sudden onset, feeling sick, vomiting, confusion, seizures and visual disturbances. Once the use of medicines containing pseudoephedrine stops and the appropriate therapy is administered, the symptoms resolve. Cases of PRES and RCVS have not been reported in Montenegro.

 

The letter on this matter intended for healthcare professionals is available here.

Regarding the upcoming New Year and Christmas holidays, and in accordance with the announcement issued by the Ministry of Labor and Social Welfare, please be informed that the Institute will remain closed on 1, 2 and 8 January 2024.

Regarding the upcoming Njegoš’s Day, Montenegrin holiday of culture, and in accordance with the announcement issued by the Ministry of Labor and Social Welfare, please be informed that the Institute will remain closed on 13 and 14 November 2023.

Pursuant to Article 9 item 51 of the Law on Medical Devices a manufacturer of a medical device is a legal or natural person responsible for its design, manufacture, packaging and labelling before placing it on the market under his own name, regardless of whether these activities have been carried out independently, or by another person on his behalf.

 

Therefore, a manufacturer is a person who independently or through contract manufacture produces a medical device, places it on the market under his own name and owns all the rights and obligations regarding the manufacture of products from his product range.

 

Thus, in accordance with the applicable regulations, the registration procedure for manufacturers that do not have their headquarters/residence in Montenegro has been amended, and therefore it cannot be considered that a natural or legal person manufacturing medical devices under his own name is a manufacturing site of a certain manufacturer, but a manufacturer.

 

The situation where one person that is a manufacturer operates under another person or corporation, as well as their corporate relations, are not relevant for the registration procedure in terms of the above-mentioned legal definition of a producer and the difference in relation to the manufacturing site.

 

In relation with the aforementioned, please be reminded that Article 140 of the Law on Medical Devices (“Official Gazette of Montenegro”, No. 24/19) defines that legal persons that manufacture medical devices and carry out wholesale and retail sale of medical devices are obliged to harmonize their operation and activities with this Law, within 24 months from the date of coming into force of this Law.

In accordance with the provisions of the Law on Medical Devices, registration holders are obliged to submit an application for amendment of the previously issued decisions, i.e., harmonization with the Law on Medical Devices, so that all stated manufacturing sites from the decisions that have the properties referred to in Article 9 item 51 of the Law on medical devices would be registered as manufacturers, in accordance with the Law into which the applicable European regulations have been transposed; mentioned regulations give the manufacturer all the rights when deciding about, i.e., choosing his own authorized representative for a certain territory.

 

Bearing in mind that the transitional period for harmonization referred to in Article 140 of the Law on Medical Devices has expired and that there are a certain number of non-compliant decisions on the registration of manufacturers that do not have their headquarters/residence in Montenegro, the Institute for Medicines and Medical Devices has decided to extend the deadline. In that sense, it is necessary to harmonize the decisions on the registration of manufacturers that do not have their headquarters/residence in Montenegro (by submitting an application for registration, i.e., an application for amendment to the registration) within 3 months from the date of delivery of this notification and no later than February 06, 2024.

 

Also, please note that in case that necessary harmonization of the mentioned decision is not carried out, the Institute will ex officio initiate the procedure of removing the manufacturer, in accordance with Article 59 paragraph 1 item 2 of the Law on Medical Devices.

 

The Institute for Medicines and Medical Devices is at your disposal for further cooperation.

The 8th #MedSafetyWeek starts today! This year again, along with more than 80 countries around the world, the Institute for Medicines and Medical Devices (CInMED) participates in the campaign that is carried out via social networks under the leadership of the Uppsala Monitoring Centre (UMC). The campaign takes place from 6 to 12 November 2023, with the aim of emphasizing the important role of patients and healthcare professionals in safe use of medicines.

 

The theme of this year’s campaign is “Who can report?” Medicines are safe and efficient, but may cause adverse reactions in certain patients. Competent regulatory institutions in the field of medicines, CInMED in Montenegro, establish a system for continuous monitoring of safety of medicines, with the aim of collecting new information on adverse reactions that are already known and timely detection of new ones.  

 

The system for adverse reactions to medicines reporting is used to detect, collect and analyze the reports on suspected adverse reactions, in order to prevent their manifestation whenever possible.

 

Every report sent by a patient, or a healthcare professional is important as it contributes to creating a true picture of safety and efficacy of a medicine. When necessary, with the aim of patients’ protection, CInMED takes adequate regulatory measures that may improve prescribing practices and treatment outcomes.

 

We hope that this campaign will encourage healthcare professionals and patients to report suspected adverse reactions to medicines, as this increases knowledge about medicines, making them safer for all of us.

 

Don’t miss the educational material prepared for the #MedSafetyWeek campaign that will be published during the week on CInMED social media and YouTube.

 

More detailed information on how to report adverse reactions are available in the section Pharmacovigilance/Adverse reactions to medicines reporting.

At the invitation of the Agency for Medicines and Medical Devices of Spain, the deputy managing director of the Institute for Medicines and Medical Devices, Ms. Mira Kontić, and the head of the Department for import and export of medicines at the Institute, Ms. Tijana Mićović, attend the 60th meeting of EMACOLEX, the working body of the European Medicines Agency for legislative issues, taking place on 2-3 November in Madrid, Spain.

 

The 60th EMACOLEX meeting is an exceptional opportunity to exchange ideas and experiences on legislative issues of national importance as well as current topics in the field of health systems of European countries. At the same time, this meeting enables broadening of perspectives regarding the shaping of regulatory frameworks on the market of medicines and medical devices, thus contributing to the improvement of the system in this area.

Participation in the activities of the most important law body of the European Union (EU) is hugely important for the Institute, and for Montenegro as well, as it provides access to information on the latest legislative changes and initiatives related to medicines and medical devices within the EU and represents an opportunity for strengthening cooperation between different countries and organizations in order to improve the quality, safety and efficiency of medicines and medical devices.

 

The exchange of experiences and cooperation is crucial for finding solutions to the numerous issues we face. Through the dialogue with European bodies, we create opportunities for mutual learning and exchange of best practices. This approach enables us to see different approaches and effectively overcome challenges. In light of these goals, the Institute is committed to continued engagement and cooperation in order to contribute to building a better future for the health system of Montenegro.

The Institute for Medicines and Medical Devices of Montenegro (CInMED) is delighted to announce its new status as an affiliated member of the International Medical Devices Regulators Forum (IMDRF). This milestone holds exceptional importance for CInMED as the regulatory authority for medical devices in Montenegro. It promises to catalyse the ongoing development and enhancement of the regulatory framework, with far-reaching implications for Montenegro’s industry, global positioning, and European integration processes.

 

Only six months after the official invitation of the chairman of the IMDRF, Dr Andrzej Rys, for CInMED to become a member of the family of international regulators in the field of medical devices, Montenegro proudly stands out as the only country in the region that has achieved this notable success, despite not being a member of the European Union (EU).

 

During the 24th IMDRF meeting, which took place in Berlin last month, representatives from CInMED, MSc Mira Kontić, Deputy Managing Director, and Dr Uroš Labudović, Head of the Centre for Medical Devices, attended the event at the invitation of the European Commission. This provided an excellent opportunity to introduce CInMED as Montenegro’s competent regulatory body in this field and to present the CInMED’s perspective and advantages of Montenegro’s market. The official application for affiliate membership status within IMDRF was also submitted.

 

IMDRF is a renowned international organization that unites regulators and experts in the field of medical devices from various parts of the world. Its primary objective is to promote global harmonization of regulatory approaches for medical devices. Membership in IMDRF offers the opportunity to exchange knowledge, experiences, and best practices among member countries, fostering an environment that encourages innovation and guarantees the safety and efficacy of medical devices. It establishes a robust and unified regulatory framework to address the growing challenges in public health protection and patient safety.

 

The members of this international organization are the most influential European and world regulators, such as the drug agencies of the USA, Brazil, Canada, Great Britain, Japan, China, Australia, etc.

For CInMED, becoming an affiliated member of IMDRF is a recognition of the high standards of quality and professionalism upheld by the Montenegrin regulatory authority. This membership opens doors to broader collaboration with other regulatory bodies and experts worldwide, enabling access to the latest information and guidelines in the field of medical devices.

 

Access to global standards and guidelines for the development and placement of medical devices will strengthen the competitive positions of Montenegrin companies on the international market and contribute to the country’s economic growth.

 

Furthermore, membership in IMDRF represents a significant step toward achieving Montenegro’s goals for EU accession. This is because embracing globally harmonized standards and regulations in the field of medical devices is crucial for EU compliance, facilitating and expediting the EU accession process.

 

This step towards IMDRF membership represents a great honor and responsibility for CInMED, along with recognition for the organization’s past efforts and dedication.

 

The status achieved by CInMED through this process opens doors to numerous advantages within this organization. It is especially important to highlight access to opportunities for professional development, staying updated on the latest trends and innovations, and strengthening our position for EU membership. Achievements in the field of medical devices, including the introduction of highly sophisticated new technologies for treating the most complex diseases, are truly pushing the boundaries of conventional medicine. Therefore, we must broaden our horizons and be prepared for the future brought about by scientific and technological advancements, while implementing measures that ensure the highest standards of patient protection.

Representatives of the Institute for Medicines and Medical Devices of Montenegro (CInMED), led by Deputy Managing Director MSc Mira Kontić and the Head of the CInMED Laboratory MSc David Kočović, attended the Final conference of the MEDI-THEFT project organized by the Italian Medicines Agency (AIFA), the project coordinator, on September 29th.

 

Representatives of European regulatory agencies and other competent authorities, as well as representatives from the private sector and pharmaceutical industry associations, attended the event.

 

The conference provided insights into the latest information regarding specific forms of pharmaceutical crime, such as medicine theft and counterfeiting. Additionally, the conference served as an opportunity to present impressive results that have been achieved and tools that have been successfully developed and implemented during the course of this two-year project, officially concluding on October 31st.

The most significant segment of the event was dedicated to the presentation of the project by AIFA and the partners of the MEDI-THEFT Consortium, among which CInMED is included. MSc Kočović presented numerous and substantial activities that CInMED has undertaken over the past two years within the MEDI-THEFT project, with a focus on raising awareness about the necessity of implementing activities and systemic solutions aimed at preventing stolen and counterfeit drugs and medical devices from entering legitimate supply chains.

 

The event concluded with a panel discussion dedicated to the operational and strategic aspects of the future use of the MEDI-THEFT platform and the continuation of activities in the fight against medicine theft and counterfeiting in partner countries on the project.

 

This project is just one of many steps that the Institute has taken and will continue to take to achieve the goal of protecting the well-being of patients through the improvement of the pharmaceutical market.

The official 24th meeting of the International Medical Device Regulators Forum (IMDRF), attended by representatives of the Institute for Medicines and Medical Devices of Montenegro, MSc Mira Kontić and Dr Uroš Labudović at the invitation of the European Commission, was held from September 25th to 29th in Berlin. Participation in such an event is of exceptional importance for the international position of the Institute and the establishment of strong connections with other regulators in the field of medical devices.

 

During the first two days, all relevant stakeholders in this field, including industry representatives and regulatory bodies, convened to present innovations in the field of medical devices. The mutual exchange of the latest knowledge and experiences is the best way to align best practices and promote the safety and efficiency of medical devices.

On September 27th, MSc Mira Kontić, Deputy Managing Director, presented the Institute as the competent regulatory body of Montenegro in this field, the regulatory framework in place, as well as the perspective and advantages of our market. This was an exceptional opportunity to demonstrate our commitment to improving the safety and efficiency of medical devices in Montenegro and to initiate further development of the medical device industry in Montenegro to provide the most advanced treatment options to our patients.

 

On September 28th, MSc Mira Kontić also introduced the Institute’s application for obtaining the status of an affiliate member in the IMDRF. This status would open doors to many advantages within this organization, with a particular emphasis on gaining access to opportunities for professional development, the latest trends and innovations, as well as strengthening our position for EU membership.

 

The Institute shares IMDRF’s vision of establishing a harmonized regulatory framework that ensures patient safety while promoting innovation. Through active participation, we aim to contribute to the creation of globally harmonized regulations that facilitate the timely introduction of safe and efficient medical devices to the market.

Please be informed that the updated Instruction – Manner of submitting application and documentation for the renewal of marketing authorisation for medicines for human use has been published on CInMED portal in the section Human medicine/Placing a medicine on the market, along with the Application for the renewal of marketing authorisation for a medicine and Cover letter – issuance of the renewal of marketing authorisation for a medicine. The Instruction in question provide information on the manner and type of required documentation to be submitted to CInMED along with the application for the renewal of marketing authorization for a medicine, as well as other information.

 

Application and cover letter forms have been also published in the section Veterinary medicines/Placing a medicine on the market.

 

Please follow updated Instruction and use relevant forms when preparing and submitting the documentation.

 

 

 

 

 

Regarding the upcoming Stathood Day, and in accordance with the announcement issued by the Ministry of Labor and Social Welfare, please be informed that the Institute will remain closed on 13 and 14 July 2023.

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.

Obavještavamo vas da je Godišnji izvještaj o prijavljenim neželjenim dejstvima ljekova za 2022. godinu objavljen na portalu Instituta u dijelu Farmakovigilanca/Godišnji izvještaji.

 

U okviru objavljenog izvještaja možete naći analizu prijava sumnje na neželjeno dejstvo lijeka koje su dostavljene Institutu u toku 2022. godine, kao i kratak pregled najznačajnijih regulatornih mjera koje je CInMED sproveo u toku prethodne godine. Izvještaj sadrži i informacije o edukativnim aktivnostima koje su realizovane u cilju razvoja sistema farmakovigilance u Crnoj Gori. 

Obavještavamo vas da je Izvještaj o prometu ljekova u Crnoj Gori za 2022. godinu objavljen i nalazi se portalu Instituta u dijelu Humani ljekovi/Potrošnja ljekova.

 

U okviru objavljenog izvještaja možete naći podatke o ljekovima koji su se prometovali u 2022. godini, na svim nivoima ATC klasifikacije, izraženo u dnevno definisanim dozama (DDD) na 1000 stanovnika na dan, kao i finansijske podatke.

 

Za izradu izvještaja su korišćeni podaci o prometu registrovanih veledrogerija, koje su obavljale promet ljekovima u Crnoj Gori, u 2022. godini (14 privatnih i 1 državna).

Na portalu CInMED

 

u dijelu Humani ljekovi/Uvoz/izvoz ljekova objavljena su sljedeća revidirana uputstva:

 

u dijelu Humani ljekovi/Kontrolisane supstance objavljena su sljedeća revidirana uputstva:

 

u dijelu O CInMED/Stručna mišljenja i CPP objavljena su sljedeća ažurirana uputstva:

 

Molimo sve podnosioce zahtjeva da se pridržavaju ažuriranih uputstava i da prilikom podnošenja zahtjeva dostavljaju dokumentaciju isključivo prema objavljenim uputstvima.

Institute for Medicines and Medical Devices (CInMED) was one of the organizers of this year’s Congress of pharmacists with international participation, which was held from 11 to 14 May in Budva featuring the slogan “Power of pharmacy – Strength of our health.”

 

Official opening of the Congress was attended by the Managing director of CInMED, Ms. Snežana Mugoša, MD, MSc, PhD, spec., who greeted all the participants and shared her enthusiasm regarding gaining new knowledge, exchange of experiences, improvement of cooperation and new acquaintances.

 

„I am sure that we share one common goal – opening of new horizons in the provision of quality health care and joining forces in the fight against real challenges that we face every day. And each challenge path is also a new opportunity – an opportunity to make a future that is healthier, safer and fairer for our patients”, said the Managing director Mugoša.

 

CInMED held its own session within the Congress which was attended by a large number of participants and that gathered the lecturers that are distinctive experts in their area. The aim of the session was to provide participants with educational and inspiring content, as well as to motivate them to reconsider their attitudes and behavior with a short session of psychotherapy.

 

Moderator of the session was CInMED Managing director, Ms. Snezana Mugoša, MD, MSc, PhD, spec. who greeted the attendees at the beginning and expressed special thanks to her colleagues from CInMED, as well as external experts, for their exceptional contribution and commitment to the development of CInMED in the previous year and a half, and then briefly presented the most significant achievements.

 

One of the most important CInMED experts, Ms. Svetlana Ibrić, PhD, who is on the prestigious list of 2% of the world’s most influential scientists for the second year in a row, spoke on the topic “Digitalization in the pharmaceutical industry: challenges and opportunities”. Through her lecture, the attendees got the opportunity to look into the future and see what it brings in the areas of development, manufacturing and distribution of medicines.

 

Recognized authority in the field of pharmacy and public health, manager for international cooperation, European integration and communication of the Agency for Medicines and Medical Devices of Serbia, Mr. Pavle Zelić, MSc. Pharm., through his inspiring lecture “We cannot be saved, yet again, we will not fail – everything you don’t know about infodemics and infodemiology, but you should ask”, pointed out one of the probably most significant topics in the areas of public health, medicine and pharmacy – dealing with misinformation, conspiracy theories and resistance to vaccines, as well as other medicines, medical devices, clinical trials, etc. He drew attention to the importance of this topic for healthcare professionals and the entire public that they can influence through their practice and dedicated work on patients’ education.

 

Ms. Ana Kontek, M. Pharm., head of the Department for availability of medicines at the Agency for Medicinal Products and Medical Devices of the Republic of Croatia, spoke about the management of medicine shortages, and about three basic segments in the area of medicines availability that are necessary for the public health protection: access to new therapeutic options that primarily cover conditions for which the medical need, medicines availability and economic efficiency of the medicines market are currently not met.

 

Mr. David Kočović, M.Sc., head of the Laboratory at CInMED, presented the MEDI-THEFT project implemented by CInMED along with the Italian Medicines Agency and other partners from the region and Europe. MEDI-THEFT project goal is to develop a platform that will provide effective support to law enforcement institutions and other private/public stakeholders in combating organized theft of medicines and their illegal distribution in the official supply chain of the European Union.

 

Director of the international agency – Pharma Expert, responsible for numerous successful lectures and workshops for pharmacists in various areas, Ms. Arijana Meštrović, Assoc. Ph.D., presented a new model of education – SMART Pharmacist project, which is supposed to motivate pharmacists and improve pharmacy practice. The main imperative is to maintain trust in pharmacists.

 

Distinguished and favorite psychiatrist and psychotherapist, Mr. Vladimir Đurić, Dr., aroused great interest among the attendees by encouraging them to reconsider their own attitudes and views of life, talking about the importance of life position, i.e. finding the right place for soul, happiness and mental health.

 

CInMED made a great contribution to the success of the IV Congress of Pharmacists and events such as this one are the best opportunity to improve cooperation between institutions, exchange views and experiences, as well as encourage ideas and innovations in the process of providing pharmaceutical health care.

Regarding the upcoming Independence Day, and in accordance with the announcement issued by the Ministry of Labor and Social Welfare, please be informed that the Institute will remain closed on 22 and 23 May 2023.

Regarding the upcoming Labour Day, and in accordance with the announcement issued by the Ministry of Labor and Social Welfare, please be informed that the Institute will remain closed on 1 and 2 May 2023.

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.

Regarding the upcoming Easter holiday, and in accordance with the announcement issued by the Ministry of Labor and Social Welfare, please be informed that the Institute will remain closed on 14 and 17 April 2023.

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.

Sastanak IMDRF

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.

Direktorica CInMED-a doc. dr Snežana Mugoša, predstavnik Misije Crne Gore pri Evropskoj uniji Aleksandar Čampar, zamjenica direktora CInMED-a mr Mira Kontić

In relation to the withdrawal of the BCG vaccine produced by the Institute of Virology, Vaccines and Serums “Torlak”, Republic of Serbia, from the market of Montenegro, the Institute for Medicines and Medical Devices would like to inform the expert and general public on the following:

 

In January of this year, the Institute for Medicines and Medical Devices, in accordance with the Law on Medicines, approved the import of this vaccine through the so-called emergency import, based on the assessment of submitted documentation which proved that the vaccine met the prescribed standards in terms of quality, safety and efficacy. The aforementioned documentation, among other things, includes two quality control certificates – Certificate of Analysis of the manufacturer of the medicine and the Certificate of Analysis issued by the National Control Laboratory of the Agency for Medicines and Medical Devices of Serbia, which is a member of the European Network of Official Medicines Control Laboratories.

 

Subsequent routine control carried out by the manufacturer determined that there was a possibility of a potential deviation of the number of live, attenuated Bacillus Calmette-Guerin (Mycobacterium bovis BCG) bacteria, compared to the number that had been declared. Therefore, expected immune response might be incomplete in an extremely small number of patients (newborns, children and adults at an increased risk for developing a tuberculosis). Due to this matter, mentioned batch of the vaccine has been withdrawn, bearing in mind that the manufacturer is obliged to withdraw a medicine from the market, even though a suspected defect that cannot cause serious consequences for human health is in question.

Expert mission aimed at implementing standards and guidelines of the European Union in the procedure of authorising and importing veterinary medicines for Montenegrin market is carried out in the Institute for Medicines and Medical Devices (CInMED), with the aim of providing quality, safe and effective medicines for animals.

 

Experts of the European Commission Mr. Paolo Pasquali, DVM PhD, public health expert from the Institute for public health of Italy and Mr. Massimo Giangaspero, DVM, MSc, PhD, from the Faculty of Veterinary Medicine, University of Teramo, Italy, will share their knowledge and many years of experience with CInMED experts in order to improve capacities in the assessment of documentation within the procedure of authorising and importing veterinary medicines. Namely, in accordance with its mission, the Institute strives to protect human and animal health by promoting rational use of medicines and to support the development of pharmaceutical sector in order to create conditions for greater availability of various veterinary medicines, respecting animals, nature and their interaction with humans.

 

In this manner, CInMED focuses on animal health and welfare bearing in mind its significance and impact on public health as a whole. 

 

“Impact of animal diseases and measures necessary to control them can be devastating for individual animals, animal population, animal owners and the economy. Animal diseases that are transmissible to humans can also significantly affect public health. Therefore, we must have enough quality and effective veterinary medicines available in order to ensure high standards of animal health and public health and the development of agricultural and veterinary sector” – declares CInMED.

 

The aforementioned project is only one of strategic steps in the improvement of the field of veterinary medicines and, deeply aware of the fact that by protecting animal health we protect health of people and environment as well, CInMED expects to carry out more extensive activities that will be enabled by the European Commission and the European Medicines Agency.

Please be informed that the instruction Manner of submission of application and documentation for the transfer of marketing authorisation to the other marketing authorisation holder , along with forms for the Application for transfer of marketing authorization to the other marketing authorization holder, Application for the cessation of validity of marketing authorisation and for the Application for notification/approval of the variation have been revised and published on CInMED portal in the section Human medicines – Placing a medicine on the market.

Same documents are also available in the section Veterinary medicines-Placing a medicine on the market.

Please be informed that revised forms for SmPC and PL have been published on CInMED portal in the section Human medicines – Placing a medicine on the market. Mentioned forms now include a QR code for online adverse reactions to medicines reporting.

Applicants are advised to use revised forms from now on.

After the support by European Medicines Agency, Italian Medicines Agency and Agency for Medicinal Products and Medical Devices of Croatia, CInMED got a new partner on the European development journey.

 

Managing director of the Institute for Medicines and Medical Devices (CInMED), MD, MSc, PhD, spec. Snežana Mugoša, and deputy managing director LL.M. Mira Kontić, paid an official visit to Malta Medicines Authority (MMA). During meetings with the managing director, PhD Anthony Serracino Inglott, and heads of directorates in the MMA, opportunities for cooperation, exchange of knowledge and experience, as well as joint activities and projects were discussed. It was concluded that there were diverse opportunities for successful cooperation and that numerous similarities between mentioned institutions, as well as between Montenegro and Malta, would contribute to creating a stable and fruitful partnership.

 

This is only one of many steps that CInMED has taken during the previous year in order to strengthen cooperation and partnership relations with eminent European institutions, which represents an excellent basis for further development of CInMED, as well as a key prerequisite for its affirmation at both European Union and international level. 

 

Successful negotiations resulted in signing the Cooperation Agreement between CInMED and MMA, which was attended by the Minister of Health of Malta, Dr. Joe Etienne Abella, as well as by numerous media representatives.

 

On that occasion, managing director of CInMED, Dr. Mugoša, expressed her gratitude to the Minister of Malta, as well as to the managing director of MMA, for showing trust and generous support.

 

„It has been a great honor and pleasure having the opportunity to visit your beautiful country and to make numerous, important acquaintances and establish contacts. Thank you for your hospitality and for the opportunity to present the Institute for Medicines and Medical Devices of Montenegro, our achievements and future plans. It is remarkably pleasing to be able to gain an insight into the business operation, experiences and internal organization of MMA. As one of the best small medicines agencies in Europe, and in many aspects similar to us, MMA will be our role model and companion on our way towards the European Union. Building a partnership with you is extremely important for the Institute for Medicines and Medical Devices of Montenegro and will greatly contribute to the Institute’s inclusion in the European family of regulators. I am certain that this will be a very successful cooperation and I look forward to new meetings, experiences, knowledge, and above all friendship,” said Dr. Mugoša.

Minister Abela: Malta is a reliable friend of Montenegro on its path towards the European Union 

Minister of Health of Malta, Dr. Joe Etienne Abela, said that the MMA would have the role of a mentor and support for Montenegro on its journey towards the implementation of standards established by the European Commission, and that meeting these standards was a significant part of the criteria for accessing the European Union.

 

„Signing the Cooperation Agreement between these two institutions built the foundation for a much wider framework of cooperation, not only at the level of institutions themselves, but also at the level of countries, especially in the fields of health and science. Therefore, with the visit of the CInMED’s managing director, Dr. Mugoša, a whole spectrum of ideas for future cooperation was initiated, not only regulatory ones, but also in the context of public health protection and education improvement.“, said the Minister Abela.

 

Managing director of MMA, PhD Anthony Serracino Inglott, said that this cooperation would be very productive and that exchange of experiences would be facilitated in this manner, as well as that the experts of these two institutions would have the opportunity to learn from each other.

 

„Since both our institutions have a small number of experts, this partnership will, through joint activities, support our efforts to regulate the markets of Malta and Montenegro in terms of providing quality, safe and effective medicines”. Far-reaching and diverse possibilities of this cooperation are particularly inspiring since, as he states, they are based on the fact that these two institutions match in numerous segments. “Given that MMA is also a teaching base of faculties and a scientific institution, the opportunities for cooperation are diverse in the sense that the privileges of personnel exchange will not be limited to expert training, but will also be extended to scientific development, as well as to the improvement of education“, concludes professor Inglott.

 

Dr. Mugoša sees this new type of partnership as a new opportunity for acquiring knowledge, recognizing and implementing modern models of business operation and work organization, as well as for developing and shaping the expertise of the CInMED personnel.

 

„We will stay on the mission to not only use, but also to create opportunities for learning and developing in all areas. We are very aware of our role and responsibilities in the health system and we approach them seriously, and we are guided by the imperative not to set limits to the improvement of knowledge, education, competences and skills, both methodological and social,” says Dr. Mugoša.

 

Agreement with the Malta Medicines Authority is a result of a continuation of the cooperation that was started and established by the delegation of the Government of Montenegro headed by the Minister of Health, Mr. Dragoslav Šćekić, during the visit to Malta in November last year. The agreement will allow establishment of the cooperation between the two institutions, but at the same time it will strengthen the relationship of the two friendly countries.

Please be informed that revised Application for issuance of import authorisation of medical devices that are not registered  and Justified proposal/statement of the import proposer of unregistered medical device  have been published on CInMED portal in the section Medical devices – Wholesale – Emergency import.

 

All applications for issuance of import authorisation of medical devices that are not registered submitted after 24 January 2023 must be submitted using revised forms.

Regarding an increased interest in the composition of vaccines lately, as well as in their safety and efficacy, the Institute for medicines and medical devices (CInMED) would like to remind the public that the composition, manufacturing, distribution and use of all vaccines in Montenegro are strictly controlled, in accordance with the highest European and international standards.

 

Precisely due to the fact that vaccines are administered to healthy people, most often to children, with the aim of protecting against infectious diseases, special attention is paid to respecting the highest standards at every step of their manufacturing, distribution and use. Substances entering into the composition of vaccines have a known effect, meet international quality standards and are present in quantities that are proven to have no harmful effect on human health. Prior to placing on the market, the efficacy and safety of the vaccine must be proven through numerous non-clinical and clinical studies.

 

Vaccines marketed in Montenegro are used in European Union member states and neighboring countries, but every batch of the vaccine (regardless of whether it obtained marketing authorisation in Montenegro or is marketed on the basis of approval of the „emergency import“), when importing into Montenegro, must be accompanied by the manufacturer’s certificate, as well as additional certificate from one of independent accredited laboratories, which confirms required quality. CInMED monitors safe use of vaccines, as well as other medicines that are on the market, through active participation and international cooperation within the international program for safe use of medicines monitoring. Additionally, safety of vaccines on the market is closely monitored through the immunization monitoring system, which is jointly carried out by CInMED and the Institute for Public Health, so that any potential issue related to the use of vaccines is identified as early as possible, and reaction of the institutions is timely and adequate.

 

Register of medicines on CInMED portal allows healthcare professionals and patients to find accurate and reliable information about vaccines authorised in Montenegro. The Summary of product characteristics (intended for healthcare professionals) and the Package leaflet (intended for patients) are also available and they are approved by CInMED within the marketing authorisation issuance procedure and contain information about the composition of the medicine, its mode of action, approved indications, as well as possible adverse reactions.

 

CInMED calls on patients to make decisions on their own health and health of their children on the basis of reliable and evidence-based information about vaccines, in cooperation with their chosen doctor and pediatrician.

Please be informed that revised Form for issuance of marketing authorisation for a medicine has been published on CInMED portal in the section Human/Veterinary medicinesPlacing a medicine on the market. All applications submitted after 1 January 2023 must be submitted using the revised Form.

Regarding the upcoming New Year and Christmas holidays, and in accordance with the announcement issued by the Ministry of Labor and Social Welfare, please be informed that the Institute will remain closed on 2, 3 and 6 January 2023.

Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency, (EMA) has recommended the revocation of marketing authorisation for medicines containing pholcodine as an active substance in the EU Member States.

Regarding this matter, the Institute for Medicines and Medical Devices (CInMED) would like to inform expert and general public that no marketing authorisation for any medicine containing pholcodine as an active substance has been issued in Montenegro. Additionally, after 2016, no import of unauthorised medicines (medicines without marketing authorisation) containing pholcodine as an active substance has been approved.

Pholcodin is a medicine that was used for many years to treat dry cough in children and adults. Previously, it was marketed in Montenegro under names Pholcodin, capsule, 10mg, Pholcodin syrup, 4mg/5ml and Pholcodin syrup 5mg/5ml, manufactured by Alkaloid AD Skopje. CInMED did not receive any report of adverse reactions to these medicines.

When assessing the safety of medicines containing pholcodine, PRAC analyzed all available data, including results of recently conducted ALPHO study. The available data showed that the use of pholcodine in the period of 12 months before general anesthesia administered with neuromuscular blocking agents is associated with the risk of development of an anaphylactic reaction (severe life-threatening allergic reaction). Due to the fact that it was not possible to identify measures that would reduce this risk, nor the group of patients for whom the benefit-risk ratio was favorable, it was recommended to withdraw this medicine from the market. PRAC recommendation will be sent to the EMA Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) which will, then, send its decision to the European Commission whose decision is legally binding for all EU Member States.

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
Web page, Linkedin and Twitter profile.”

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.