Based on the recommendation of the European Medicines Agency (EMA) and in cooperation with the Institute for Medicines and Medical Devices (CInMED), the company Alkaloid d.o.o. as the marketing authorisation holder for Analgin (metamizole sodium) has informed healthcare professionals about important measures to minimise serious outcomes of the known risk of agranulocytosis. Agranulocytosis is an already known adverse reaction to metamizole-containing medicines, which occurs very rarely, and represents a sudden and sharp decrease in granulocytes (a type of white blood cell) that can lead to serious or even fatal infections.

Metamizole-containing medicines are marketed in Montenegro under the name Analgin, manufactured by Alkaloid AD, and are available as tablets as well as in the form of a solution for injection. Analgin is authorised for treating pain and fever when other available medicines are not effective, and patients should be warned to stop using this medicine and inform their healthcare professional if they develop symptoms of agranulocytosis. These include fever, chills, sore throat and painful sores on the moist, inner body surfaces (mucosa), especially in the mouth, nose and throat or in the genital or anal regions. Symptoms of agranulocytosis may occur in the course of use of metamizole-containing medicines, or shortly after. When metamizole is used to treat fever or together with antibiotics, the early symptoms of agranulocytosis may be masked.  

Information on metamizole-containing medicines will be updated to include new recommendations. In addition to Analgin, the medicine Pyreox (metamizole sodium) manufactured by ICN Polfa Rzeszów S.A. is also authorised in Montenegro, but is not on the market yet. The letter intended for healthcare professionals may be found on the portal in the section Pharmacovigilance/Direct Healthcare Professional Communication. No cases of suspected agranulocytosis related to the use of Analgin have been reported to the Institute of Medicines and Medical Devices. CInMED invites healthcare professionals and patients to report any suspected adverse reaction to a medicine using the online reporting form available here.

Since there has been an ongoing process of harmonising the documentation for the registration of medical devices in the European Union due to the transition from EU directives (93/42 EC, 90/385/EEC and 98/79 EEC) to EU Regulations (MDR 2017/745 and IVDR 2017/746), the manufacturers of medical devices have been submitting to the notified bodies applications for recertification of EC certificates issued in line with previously valid legislation with the aim of issuance of new certificates in accordance with new regulations.

Consequently, a large number of applications for extension of the Decision on the registration of medical devices has been submitted to the Institute at the same time which may lead to the situation that decisions on the registration expire, but a decision on the extension of the registration, i.e. a new decision on the registration of medical device has not been issued yet.

Namely, in accordance with Article 41 of the Law on Medical Devices (“Official Gazette of Montenegro”, No. 24/19), the Institute for Medicines and Medical Devices shall issue a decision on the registration of a medical device the validity period of which may not be longer than 60 days from the expiry date of a document on conformity (EC certificate), while medical devices may be present on the market for a maximum of 90 days from the expiry date of the decision on the registration of the medical device.

Based on the above mentioned, the validity period of the decision on the registration was 25 July 2024, whereby medical devices could be present of the market for a maximum of 90 days from the expiry date of the decision on the registration of the medical device, i.e. until 25 October 2024, about which you have been already informed.

As the marketing of medical devices in Montenegro is carried out on the grounds of a decision issued by the Institute and especially bearing in mind that the application of the provisions of the Law on Medical Devices will affect regular supply of the Montenegrin market and health institutions with the necessary medical devices by foreign manufacturers, the Institute has informed the Customs Administration that until the this issue is resolved, the import of medical devices will be carried out on the grounds of the existing decision and an evidence that an application for the extension of the registration or for the registration of the same medical device has been submitted.

In accordance with obtained approval wholesalers and authorized representatives of manufacturers may submit expired decisions on the registration/extension of the registration of medical devices in tender procedures (procedures of public procurement), at customs terminals when importing medical devices, as well as for the purposes of approving manufacturer/supplier orders after the expiration of the specified deadline, i.e. until the issuance of a new decision on the registration/extension of the registration of the medical device, and until the end of the current year at the latest.

Please be informed that the Report on medicines consumption in Montenegro 2023 has been published and is available on the portal of the Institute in the section Human medicines/Consumption of medicines.

The Report contains the data on the medicines that were marketed during 2023, on each level of the ATC classification, expressed in daily defined dose (DDD) per 1000 inhabitants per day, as well as the financial data.

Data provided by registered wholesalers that were performing marketing of medicines in Montenegro in 2023 (14 private and 1 state-owned) were used to create this Report.

We would like to inform all applicants and marketing authorisation holders that the forms for Summary of product characteristics (SmPC) and Package leaflet (PL) have been changed and are available on CInMED portal in the section Human medicines – Placing a medicine on the market . The change refers to new QR code for online reporting of suspected adverse reactions to medicines. Accessing the form by scanning old QR code will be possible until January 2025; after that accessing the form will only be possible by using new QR code. We kindly ask all applicants and marketing authorisation holders to use updated forms.

The Institute for Medicines and Medical Devices, in cooperation with the WHO Collaborating Centre for international monitoring of safe use of medicines – Uppsala Monitoring Center (UMC), has improved the application for online reporting of suspected adverse reactions to medicines. It provides users with new benefits and enables even simpler and faster communication of healthcare professionals and patients with the Institute.  

Online reporting form may be accessed by scanning the QR code in any browser and is suitable for completing using a mobile phone. A significant new feature of the application is that now it can work offline. In this case, the entered data is stored on the device and will be sent automatically to the Institute once the device gets connected to the Internet. Additionally, users may save the application on their mobile phone, following these steps.

At the invitation of the European Medicines Agency (EMA), the Institute for Medicines and Medical Devices (CInMED) has become one of the partners of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance, ENCePP. ENCePP network brings together research centres, institutions and organizations that collect data from the field of health, with the aim of better monitoring of benefit-risk ratios in the use of medicines at the EU level.  

ENCePP network combine capacities and resources in the field of pharmacoepidemiology and pharmacovigilance throughout Europe and provides a platform for the cooperation of public and private institutions and organizations. This cooperation enables the implementation of high-quality, multicentre, independent non-interventional studies, as well as the development and maintenance of methodological standards and management principles for research in the field of pharmacovigilance and pharmacoepidemiology. The ENCePP network is also a network of excellence in pharmacoepidemiology that may be used in public health emergencies.

Since 2007 EMA has been coordinating the ENCePP network and the invitation for cooperation was sent to CInMED within the framework of support to the EU candidate countries. As an ENCePP partner, CInMED will get the opportunity to use joint expertise, as well as to participate in plenary meetings and working groups, which is very significant for the improvement of national capacities in this area. More information about the activities of the ENCePP network and its partners is available at https://encepp.europa.eu/index_en.

Upon the decision of the European Medicines Agency (EMA) to suspend the marketing authorisations for all medicines containing 17-hydroxyprogesterone caproate (17-OHPC) as an active substance in the EU Member States, the Institute for medicines and medical devices informs the public that it initiated procedures within its jurisdiction. Namely, in cooperation with the marketing authorisation holder for Progesteron Depo, solution for injection, 250 mg/ml, in July this year the Institute informed healthcare professionals prescribing and dispensing this medicine that its marketing authorisation would cease to be valid and the medicine would no longer be available in Montenegro. 

Upon assessing the benefit-risk ratio for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) and concluding that it was no longer positive, the European Union decided to suspend the marketing authorisations for all medicines containing this substance by 24 August 2024. 

The benefit-risk ratio for medicines containing this substance was examined in studies the aim of which was to examine possible connection between the use of this form of progesterone and the occurrence of cancer in persons who were exposed to 17-hydroxyprogesterone caproate in the uterus. The study showed that the risk of the occurrence of cancer was possible, but it could not be confirmed due to the limitations of the study, i.e. the existence of a large number of factors that could influence the occurrence of cancer. The results of the mentioned study refer exclusively to medicines containing this form of progesterone. Additionally, the conclusion is that the medicine does not have a satisfactory level of efficacy in relation to the possible risk, so the overall benefit-risk ratio is no longer considered positive.

Marketing authorisation holder for Progesteron Depo submitted the application for cessation of validity of marketing authorisation to the Institute for medicines and medical devices. Additionally, according to the information provided by the marketing authrisation holder, the medicine in question was last time imported in March 2024, and at the moment of delivery of the notification by the EMA, the Institute received information from the marketing authorisation holder that the medicine in question was out of stock at the distributors.

Please note that medicines containing other forms of progesterone are available in Montenegro and are not affected by the aforementioned decision, so healthcare professionals may consider alternative treatment options. It is necessary for patients to consult with their doctors about the continuation of the therapy. Also, please note that the Institute has not received reports of suspected adverse reactions to this medicine that would require taking regulatory measures in accordance with the Law.

In accordance with European standards, the Institute will continue to monitor and implement all decisions made by the scientific committees of the European Medicines Agency and the European Commission and to take appropriate regulatory measures in cooperation with marketing authorisation holders and healthcare professionals.

Please be informed that an updated application form for notification/approval of a variation has been published on the CInMED website. Small updates are related to the application for variations that are of a local administrative nature (changes in packaging, EAN code, etc.).

In the period after 24 July 2024 the Institute for Medicines and Medical Devices shall give the approval to authorized representatives of manufacturers of medical devices to extend the validity of all expired decisions on registration/extension of registration of medical devices for a period of 90 days from the date of expiry of the decision.

In accordance with given approval wholesalers and authorized representatives of manufacturers may submit expired decisions on registration/extension of registration of medical devices in bidding processes (public procurement procedures), at customs terminals when importing medical devices, as well as for the purposes of approving orders of manufacturers/suppliers, within 90 days from the date of expiry of the decision on registration/extension of registration of medical devices.

Along with expired decision on registration/extension of registration, the authorized representative of the manufacturer shall submit a Confirmation of receipt of the application issued by the Institute for Medicines and Medical Devices, stating that the applicant is in the process of issuing a Decision on the extension of registration of a medical device.

According to the Law on medical devices (“Official Gazette of Montenegro”, No 24/19),  and with regards to Article 120 of the EU Regulation 2017/745/EU (with amendments No 2020/561/EU and 2023/607/EU) prescribing the transition time for the alignment of medical devices and taking into account the corresponding application of the opinion of the Ministry of health of Montenegro (No 1-040/23-4279/2 from 14 December 2023), the Institute for medicines and medical devices shall apply new requirements and manner of recognition of EC certificates – foreign certificates of conformity of medical devices as follows:

1. If the procedure for the alignment of medical devices with EU Regulation 2017/745 has been initiated by the submission of documentation by the manufacturer to the notified body, the procedure for recognizing the EC certificate is as follows:

If the Certificate of Conformity – EC certificate issued by the authorized body in accordance with the previously valid directives was valid on 26 May 2021 and has not been subsequently withdrawn, it will remain in force even after the expiry of the validity date provided on the certificate until the following dates:

31 December 2027 – for medical devices of risk class III, IIb which are implantable (with the exception of sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors), AIMD medical devices.

31 December 2028 – for medical devices of risk class IIb which are not included in the item a., IIa and I which are placed on the market in sterile condition or with a measuring function.

In order for medical devices to be placed on the market and put in use on the territory of Montenegro by December 2027 and 2028, the following requirements must be met:

• that they are still in compliance with the directives 90/385/EEC and 93/42/EEC;
• that there are no significant modifications regarding the design and purpose of the medical device;
• that the medical device does not pose an unacceptable risk to health or safety of patients, users or other persons or to other aspects of health care;
• that the manufacturer has established a quality management system in accordance with Article 10(9) of the MDR no later than 26 May 2024;
• that the manufacturer has submitted official application to the authorized conformity assessment body no later than 26May 2024;
• that the designated body and the manufacturer have signed a written agreement in accordance with Annex VII of the MDR, no later than 26 September 2024;

2. If the procedure for the alignment of medical devices with Regulation 2017/745 has not been initiated by the submission of documentation by the manufacturer to the notified body, the procedure for recognizing the EC certificate is as follows:

– If the EC certificate was issued by an authorized body in accordance with the previously valid directives 90/385/EEC and 93/42/EEC from 5 May 2017 and was valid on 26 May 2021 when the EU Regulation 2017/745 began to be applied, and which was not subsequently withdrawn and the manufacturer did not submit the official application to the authorized body for conformity assessment, i.e. the manufacturer and the authorized body did not sign a written agreement in accordance with Annex VII of the EU Regulation, the Institute will issue decisions on extension of registration of medical devices with a period of validity until 26 May 2024.

According to Article 41 of the Law on Medical Devices, the Institute issues a decision on registration of a medical device the validity period of which may not be longer than 60 days after the expiry of the validity of the Certificate of conformity, and accordingly 60 days were added to the above-mentioned deadline, 26 May 2024, as prescribed by the Law; it means that decisions on registration with a validity period until 24 July 2024 were issued for all medical devices for which the manufacturer did not submit the official application to the authorized body for conformity assessment, i.e. the manufacturer and the authorized body did not sign a written agreement in accordance with Annex VII of the EU Regulation.

According to the Law on medical devices wholesale of medical devices shall include procurement, storage and distribution, except for dispensing a medical device to an end user, i.e. the patient for his/her personal needs.

Article 41 paragraph 3 of the Law on medical devices prescribes that medical devices for which no application for registration extension has been submitted may be on the market for a maximum of 90 days from the expiry of the validity date of the Decision on the registration of the medical device.

Bearing in mind the above-mentioned and the fact that medical devices may be marketed on the territory of Montenegro 90 days after the expiration of the Decision on the registration, as well as the problems manufacturers face in the transition time, we reckon that the import of medical devices in the period after 24 July 2024, i.e. after the expiry of the Decision on the registration, may be performed on the basis of them until the expiry of the prescribed period of 90 days.

Please be informed that document Manner of submitting application and documentation for variations is now published on the CInMED website, along with an updated application form for notification/approval of a variation. Marketing authorization holders are asked to follow the published instructions and to use the updated application form when preparing and submitting documentation for variations.

Report on the results of spontaneous reporting of adverse reactions to medicines in 2023

Please be informed that the Report on the results of spontaneous reporting of adverse reactions to medicines in 2023 has been published on the portal of the Institute in the section Pharmacovigilance/Annual reports.

The published report contains the analysis of adverse reactions to medicines reports sent to the Institute for medicines and medical devices during 2023, a brief overview of the most important regulatory measures taken by CInMED during the previous year, as well as information on the educational activities conducted with the aim of the improvement of the pharmacovigilance system in Montenegro.

Compared to the previous year, in 2023 there was a significant increase in total number of submitted reports which is a result of greater involvement of healthcare professionals in the system of monitoring of the use of medicines. Bigger number of reported adverse reactions is primarily the result of the SMART Pharmacist – Therapy Management Process project, which was launched in September 2023 and organized by CInMED. Its goal was to educate and improve the competencies of pharmacists as the most accessible providers of health care, and the majority of adverse reactions to medicines reports received in 2023 were submitted by pharmacists who participated in the mentioned project. Majority of submitted reports related to medicines that act on the cardiovascular system, which is expected, considering that this group of medicines is the one most often used in Montenegro. When it comes to adverse reactions, majority of reported reactions related to disorders of the digestive system and reactions on the skin in the form of rashes and redness. On this occasion, CInMED would like to remind healthcare professionals and patients that during summer months it is necessary to pay special attention to the fact that many medicines (antibiotics, diuretics, pain relief medicines, retinoids…) can increase the skin’s sensitivity to UV rays and cause photosensitivity reactions. When prescribing and dispensing these medicines, patients should be warned to read the package leaflets of a medicine, as well as to take the necessary measures to protect the skin from UV rays, so as to prevent photosensitivity reactions.

CInMED would like to thank all healthcare professionals and patients that by reporting adverse reactions contribute to monitoring of the use of medicines in Montenegro.

On the occasion of 15 years since its establishment, the Institute for medicines and medical devices of Montenegro (CInMED) decided to make a valuable donation aimed at citizens’ well-being, confirming once more its commitment to social responsibility.

This time, CInMED’s contribution to the community was given in the form of a recognition of nature as a source of health and well-being. Through successful cooperation with the company “Zelenilo” Podgorica and the Municipality of Podgorica, a children’s park has been built in Block 6, on the corner of Meša Selimovića St. and Mihaila Lalića Blvd., which will be an oasis of joy for our youngest fellow citizens, and at the same time a symbol of importance of preserving nature and promotion of a healthier lifestyle.„Health is an absolute priority in our calling, but it cannot be complete without harmony with nature. Therefore, today we are prescribing a tree as a universal medicine as a symbol of healthy environment that nourishes, heals and inspires us“, said the managing director of CInMED, Ms. Snežana Mugoša, MD, MSc, PhD, spec. 

Opening of the children’s park was attended by CInMED representatives led by the managing director, Ms. Mugoša, representatives of „Zelenilo“ Podgorica, led by the managing director Mr. Petar Krivokapić, then the deputy mayor, Mr. Luka Rakčević, as well as by many citizens.

„CInMED will remain committed to the charity work, and this deed is only one out of our many efforts to inspire others to follow our example of providing support to the community and making positive changes that will bring honor to our, but also to future generations, said Ms. Mugoša.

It is our great pleasure to announce that the Laboratory of the Institute for medicines and medical devices of Montenegro has been awarded an accreditation certificate to MEST ISO/IEC 17025:2018 – General requirements for the competence of testing and calibration laboratories, by the Accreditation body of Montenegro.

Main goal of our Laboratory is protection of Montenegrin market and citizens from the occurrence of falsified and substandard medicines, as well as the improvement of scientific-research activity of the Institute, which is a teaching base of the University of Montenegro.

The Institute continuously works on the improvement of business operation quality and application of international and European standards. Since the Laboratory became an organisational unit in 2021, the Institution has been giving a great deal of attention to the establishment of working system in line with standards requirements related to the quality system of testing laboratories. 

Laboratory methods conducted with the aim to detect falsified and substandard medicines, and which are included into the accreditation scope are listed as follows: 1. Determining the mass uniformity of a single-dose preparations; 2. Comparison of diffractograms of recorded samples with diffractograms from the reference database; 3. Identification of crystalline phases in samples of solid forms of medicines and dietary supplements by means of X-ray diffraction.

We believe that with the consistent application of adopted standards and continuous improvement of the competences of our experts we will significantly contribute to the protection of citizens of Montenegro from falsified and substandard medicines and dietary supplements. 

Please be informed that the Institute for medicines and medical devices (CInMED) will not publish the Report on the medicines consumption for 2023 according to the established plan. That is due to the lack of the official data on estimated number of inhabitants in the municipalities in the middle of the year, which we obtain from the Statistical Office of Montenegro (MONSTAT). Given the fact that the census was completed at the end of 2023, we need to wait for official data from MONSTAT in order to ensure the highest degree of accuracy in our report.

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.

The applicants are kindly asked to follow the updated Instruction when preparing and submitting the documentation.

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.

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:

• Potrebna dokumentacija za izdavanje saglasnosti za uvoz ljekova koji nemaju dozvolu za stavljanje lijeka u promet i izdavanje odobrenja za uvoz/izvoz rizičnih ljekova (ažurirano 6.6.2023. godine)
• Uputstvo za popunjavanje excel tabele za uvoz ljekova koji nemaju dozvolu za stavljanje lijeka u promet (ažurirano 6.6.2023. godine)

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

• Dokumentacija potrebna za izdavanje dozvole za uvoz, izvoz i tranzit droga i uputstvo za popunjavanje obrasca zahtjeva (ažurirano 6.6.2023. godine)
• Dokumentacija potrebna za izdavanje dozvole za uvoz, izvoz i tranzit prekursora i ljekova koji sadrže prekursore i uputstvo za popunjavanje obrasca zahtjeva (ažurirano 6.6.2023. godine)

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

• Dokumentacija potrebna za izdavanje stručnog mišljenja o izuzeću od odobrenog pakovanja (ažurirano 6.6.2023. godine)
• Uputstvo o načinu podnošenja zahtjeva za izdavanje CPP sertifikata (ažurirano 6.6.2023. godine)

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

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.