Please be informed that the new CInMED portal has been created. In the next period, we will work on content migration, so certain non-functionalities may be expected. Until the new portal is fully functional, the old one will be available on the link: https://secure.cinmed.me/Portal
With the purpose of improvement of functionality of the portal and availability of information, we encourage CInMED portal users to send all their comments, suggestions, questions and doubts to the e-mail address [email protected].
MEDI-THEFT 2nd Newsletter provides information about the realized project activities, further plans, principles of operation of the MEDI-THEFT platform, and featuring a valuable interview by one of the founders of the Crime&tech company, Dr. Marco Dugato (UNICAT).
The Project foresees the publication of two Newsletters per year, to keep stakeholders and the general public updated on the most important news, the relevant progress and all the planned or attended events.
Announcements and additional information can be found on the official MEDI-THEFT |
7th #MedSafetyWeek has just started! From today until the end of the week we will be among 82 countries that participate in the campaign organized through social networks and led by WHO Collaborating Centre for International Drug Monitoring – Uppsala Monitoring Centre (UMC). The campaign is supported by members of Heads of Medicines Agencies (HMA) and International Coalition of Medicines Regulatory Authorities (ICMRA). Theme of this year’s campaign is “How patients and healthcare professionals make safety work” and it will focus on how important role of patients and healthcare professionals is for safe use of medicines.
Medicines are safe and effective, however, in some patients they can cause adverse reactions. Competent regulatory institutions in the field of medicines, in Montenegro it is CInMED, establish a system for continuous monitoring of medicines safety, with the aim to collect new information on adverse reactions that are already known and also detect entirely new ones in a timely manner.
Adverse reactions reporting system (Reporting scheme), established by CInMED, detects, collects, analyzes reports of suspected adverse reactions, with the aim of preventing their occurrence in other patients.
Every report submitted by a patient, or a healthcare professional is significant, as it contributes to creating a real picture of safety and efficacy of the medicine. If necessary, in order to protect patients, CInMED implements adequate regulatory measures that can contribute to improvement of prescribing practices and better outcome of treatments.
We hope that this campaign will encourage everyone to report suspected adverse reactions, as by doing so, they contribute to expansion of knowledge about medicines, which, in the end, makes them safer for all of us.
Detailed information on how to report a suspected adverse reaction is available in the section Pharmacovigilance/How to report an adverse reactions to medicines.
Materials used in the campaign are available on CInMED Instagram account and Youtube channel.
Institute for Medicines and Medical Devices (CInMED) participates in global campaign led by World Health Organization (WHO) which celebrates the Antimicrobial Awareness Week every year from 18 to 24 November. This year, the theme of the campaign is “Preventing Antimicrobial Resistance Together”.
Antimicrobial resistance is a resistance of microorganisms (bacteria, viruses, parasites and fungi) to antimicrobial medicines, while the resistance of bacteria to the action of antibiotics is referred to as an antibiotic resistance. Excessive, improper and unnecessary use of antibiotics in animals and humans favors the development of antibiotic resistance, which represents a global problem and a serious danger to human health. The number of infections cauesed by bacteria resistant to the action of antibiotics is on the rise, while the number of new available antibiotics is not large, which increases the threat that antibiotic resistance represents to our health.
Due to mentioned reasons, we encourage all healthcare professionals and patients to use antibiotics rationally and responsibly:
- antibiotics are used to treat bacterial infections, but not infections caused by viruses
- antibiotics do not reduce fever
- antibiotics are prescription medicines
- antibiotics should be used only when prescribed by a doctor, at regular intervals, for as long as the doctor has prescribed.
Educational material prepared by CInMED on this occasion is available here.
First annual Conference of the Institute for Medicines and Medical Devices of Montenegro entitled “European perspective of CInMED – to achieve mutual goal through cooperation and partnership” took place from 1 to 3 December 2022 in CUE Hotel in Podgorica.
During the conference, new competences of the Institute were presented, along with current development in the field of medical devices legislation and trainings in the area of Good Distribution Practice Guidelines (GDP), Good Pharmacovigilance Practice Guidelines (GVP) and the protection system against falsified and substandard medicines were organized as well. In cooperation with colleagues from the Italian Medicines Agency, we presented the MEDI-THEFT project that the Institute has been implementing in cooperation with EU partners, which aims to prevent stolen and falsified medicines from entering into legal supply chain.
Conference was concluded with a round table entitled “To achieve mutual goals through partnership”, which was entirely devoted to questions and comments of participants.
It was concluded that the organization of such events was the best manner to exchange knowledge and experience and discuss issues of importance in the field of medicines and medical devices, but also to establish contacts and good partnership relations that would result in further positive steps in the business operation of the Institute and its clients and associates.
The Institute for Medicines and Medical Devices of Montenegro is highly dedicated to the improvement of international cooperation with numerous regulatory bodies and international organizations in the areas of its competences. This is supported by the invitation of the Pharmaceutical Inspection Cooperation Scheme – PIC/S to the congress organised in honor of the celebration of 50 years of establishment of this particularly important international association.
The influence of PIC/S is of priceless importance for conducting inspections of the manufacture and distribution of medicines, especially in terms of establishing and harmonizing legislation and standards at the international level.
The Congress was attended by the highest representatives of the European Commission, European Medicines Agency, as well as European and international regulatory bodies in the field of medicines and medical devices. On that occasion, CInMED representatives have established contacts and exchanged opinions regarding further CInMED’s path of development and joining the European family of regulators. Representatives also presented activities that were carried out with the aim of reaching European standards in the conduction of GMP and GDP inspections, i.e., supervision over the manufacture and marketing of medicines and in addition, possibilities of CInMED becoming a full member of the PIC/S even before Montenegro’s accession to the European Union were also considered.
The support of numerous international partners has been gained as a result of the participation of Institute’s representatives at this prestigious event, with a special emphasis on the support of European Medicines Agency’s (EMA) Executive Director, Ms. Emer Cooke, as well as of Mr. Paul Gustafson, PIC/S Committee Chairperson. The European Commission will in the upcoming period assess the capacity of CInMED to respond to the requirements of European standards for the conduction of inspections of the manufacture and distribution of medicines. The outcome of the positive evaluation of the European Commission will be the recognition of the findings of the CInMED Inspectorate by all member states of the European Union, as well as the acquisition of full membership in the PIC/S under the accelerated procedure.