The Institute for Medicines and Medical Devices was established by the Law on Medicinal Products, as an independent regulatory body of Montenegro in the field of medicines and medical devices and as a scientific research organization. The Institute is a legal successor and continues the work of the Agency for Medicines and Medical Devices, established by the Decision of the Government of Montenegro in 2008.
Since its establishment, the Institute has continuously strived to implement the highest European and international standards and achieve quality, impartiality and transparency in its work. The Law on Medicinal Products extends the field of activity to scientific research and thus continues its work as the Institute for Medicines and Medical Devices of Montenegro.
The abbreviated name of the Institute, in accordance with the Statute, is CInMED.
By decision of the Ministry of Education, Science and Innovation No. 0402-082/23-1739/4 of 12 of January 2024, the Institute was issued a license to conduct scientific and research activities in the field of medical sciences.
By decision of the Ministry of Economic Development No. 002-350/22-4441/2 of 28 of February 2022, it was determined that the Institute meets the requirements for conducting innovation activities and was entered into the Register of Innovation Activities.
Competencies of the Institute are listed below:
Competencies of the Istitute in accordance with the Law on medicines
- issue marketing authorisation, decide on variation, renewal, transfer, suspension and revocation of marketing authorisation;
- register traditional herbal and homeopathic medicinal products;
- issue clinical trial authorisations, decide on amendments, conducts control of clinical trials and record non-interventional studies;
- establish and organize the system of pharmacovigilance with the purpose of monitoring safety of medicinal products on the market and detecting changes in relation to risk-benefit ratio of their use;
- issue manufacturing authorisations;
- issue wholesale authorisations for medicinal products for human use;
- assess compliance with GMP, GDP, GVP and GCP guidelines;
- issue CPP;
- grant approval for the import of medicinal products for which marketing authorization is not issued in accordance with this Law;
- issues authorisation for the procurement of a veterinary medicinal product for which a marketing authorisation has not been granted in accordance with this Law
- issue authorisations for narcotics and precursors in accordance with special laws;
- grant approval for import and export of immunological medicinal products and medicinal products from the blood and plasma, as well as approval for export of these medicinal products or which marketing authorization is not issued;
- conduct quality control, as well as control of the supply chain for the purpose of detecting falsified and substandard medicinal products in the legal supply chain;
- set maximum prices of medicinal products in accordance with this Law;
- give expert opinion on the classification of a product into a medicinal product or a group of medicinal products and other expert opinions and expert advice within its competences;
- inform expert and general public about medicinal products, organize professional and educational gatherings and prepare and publish professional publications within its competences;
- carry out inspections in the area of manufacture and wholesale of human and veterinary medicinal products, pharmacovigilance and clinical trials;
- collect and process data on the consumption of human medicinal products;
- cooperate with international entities and national regulatory bodies in the field of medicinal products and medical devices;
- make connections with international information networks about medicinal products and with the regulatory bodies responsible for medicinal products and medical devices and their associations;
- adopts secondary legislation within its competencies for the implementation of this Law with the approval of the Ministry;
- keep registers in accordance with this Law and issue certificates regarding the data contained therein;
- classify medicinal products in accordance of this Law;
- carry out activities in the field of medical devices in accordance with a special Law;
- carry out educational and scientific research activities in cooperation with faculties of health orientation in the field of medicinal products and medical devices and other related areas of interdisciplinary research;
- exchange data and information on veterinary medicinal products with the competent state administration body for veterinary medicinal products which are important for the performance of tasks within the scope of competence of these authorities;
- shall take the necessary measures to ensure cooperation with customs authorities;
- perform other duties in accordance with the Law and the Statute.
Competencies of the Istitute in accordance with the Law on medical product
- enter, delete and keep a register of manufacturers and legal persons that perform wholesale, import and export of medical devices, as well as a register of specialized retail stores;
- enter, delete and keep a register of medical devices that may be marketed in Montenegro;
- grant authorization for import of unregistered medical devices;
- grant authorization for the commencement of clinical investigations and control the implementation of clinical investigations;
- implement a system of vigilance;
- decide on the classification of medical devices when it comes to the combination of medicines and medical devices, medical devices and objects of general use or classification of medical devices and gives expert opinions from their jurisdiction;
- in the procedure for determining the conformity of medical devices with the requirements prescribed by this Law, give opinion to a designated and authorized body;
- cooperate with international entities and national regulatory bodies in the field of medical devices;
- perform other tasks, in accordance with the law.
Competencies of the Istitute in accordance with Law on Prevention of Drug Abuse
- give an opinion on the List of drugs, psychotropic substances and herbs that can be used for drug manufacture;
- issue a license for the manufacture and marketing of drugs;
- determine the annual needs for drugs for medical and pharmaceutical purposes;
- approve the maximum quantity of drugs that a legal entity which has a manufacture and marketing authorization can produce, i.e. keep in storage during a calendar year;
- issue a special authorization for import, export or transit of drugs to legal entities that have manufacture and marketing authorization;
- within three months from the day of expiration of the authorization, return the authorization for import of drugs to the competent authority of the state that issued that authorization, with the notification that the export of drugs has not been performed;
- issue a permit for ships and aircraft in international traffic to be able to possess drugs used to provide first aid, in the quantities necessary for that purpose.
Competencies of the Istitute in accordance with Law on control of manufacture and marketing of substances that can be used in the manufacture of narcotic drugs and psychotropic substances
- gives an opinion on the List of precursors classified by category;
- issues, amends, or renews an authorisation for the manufacture of precursors of the first, second, third, and fourth categories;
- issues, amends, or renews an authorisation for the market of precursors of the first, second, and third categories;
- issues an authorisation for the import and export of precursors of the first category used for the manufacture of medicinal products and precursors of the fourth category.
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