The Institute for Medicines and Medical Devices was established by the Law on Medicines, 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 Medicines 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 the decision of the Ministry of Science No: 01-760/2 from April 21, 2017, the Institute was issued a license to perform scientific research activities in the field of medical sciences and interdisciplinary research.
By the decision of the Ministry of Science No: 03/2-051/20-1482/2 from September 9, 2020, it was determined that the Institute meets the conditions for performing innovation activities and it’s entered in the Register of Innovative Organizations.
Competencies of the Institute are listed below:
- issue of marketing authorisation;
- issue manufacturing and wholesale authorisations for medicinal products for human use;
- issue an clinical trials authorisation, amendments to the authorisation, conduct inspection and monitor the safety of the investigational medicinal product;
- record non-interventional clinical trials;
- establish and organize a pharmacovigilance system in order to monitor safety of medicinal products on the market and detect any changes in relation to benefits and risks of their use;
- issue certificates on Good Manufacturing Practice, Good Clinical Practice and other certificates in accordance with this Law;
- issue certificates for the purpose of export of medicinal products in accordance with recommendations of World Health Organisation;
- issue consent to import of unauthorised medicinal products;
- issue authorization for narcotic drugs and psychotropic substances in line with the legislations regulating this areas;
- issue approval for import and export of immunological medicinal products and medicinal products from the blood and plasma;
- conduct quality control in accordance with this Law;
- participate in international standardization in the field of medicinal products;
- perform collecting and processing of data on marketing and consumption of medicinal products;
- keep the registers stipulated by this Law;
- conduct inspection surveillance on implementation of this Law;
- inform and educate on medicinal products, organise professional and educational conferences and provide information of importance for the conducting measures of rational use of medicinal products;
- carry out the cooperation with international entities and national regulatory bodies in the field of medicinal products;
- participate in the harmonisation of regulations in the field of medicinal products with regulations of the European Union and regulations and guidelines of international institutions;
- issue expert opinions on the classification of the products into the medicinal product or group of medicinal products as well as other expert opinion and professional consultancies within its jurisdiction;
- carry out activities related to disposal and destruction of waste for its own purposes;
- establish maximum prices of medicinal products for human use, in accordance with criteria established by the Government;
- perform activities in the field of medical devices in accordance with special Law;
- perform educational, scientific and research work in cooperation with the faculties for health sciences in the field of medicinal products and medical devices and other related fields of interdisciplinary research;
- perform other tasks in accordance with the law.
- 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.
- 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.
- propose a List of precursors classified by categories;
- issue a manufacture authorization for the of precursors;
- issue a marketing authorization of precursors;
- issue approval for the use of precursors to pharmacies, veterinary institutions, police, customs, laboratories, the Army of Montenegro, institutions engaged in teaching and research and other legal entities that need precursors to perform activities, in accordance with their needs;
- propose annual needs for precursors that are pharmacologically active substances used in the medicinal products manufacture;
- issue authorization for import, export, transit and transportation of precursors of the first category which are pharmacologically active substances used for the medicinal products manufacture;
- before issuing export authorization of precursors, submit the prescribed data to the competent authority of the state to whose territory the precursor is to be exported;
- keep a register of legal entities that perform manufacture, marketing, import, export, transit and transportation of precursors, as well as a special register of authorizations issued.
In addition to the tasks performed by the Institute in the previous period and the scope of which has been expanded by new laws, the Institute has been assigned entirely new competencies, some of which are as follows:
- Inspectorate – Conducts inspections in the field of medicines, with regard to manufacture, wholesale of medicines, pharmacovigilance, clinical trials of medicines, as well as supervision over compliance with guidelines of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP) and Good Practice in Pharmacovigilance (GVP). Expert assessment of compliance with principles and guidelines of the European Union (whose translations are published on the portal of the Institute and the Ministry of Health) is performed by pharmaceutical inspectors of the Institute:
- Guidelines on Good Manufacturing Practice (GMP)
- Guidelines on Good Distribution Practice (GDP),
- Guidelines on Good Clinical Practice (GCP),
- Guidelines on Good Pharmacovigilance Practice (GVP).
Laboratory – Determines the fulfillment of conditions regarding quality standards by laboratory quality control of each medicine for which doing so is prescribed by the Law, in accordance with European, or national pharmacopoeia, other recognized pharmacopoeias, or other validated methods of analysis. The Laboratory is of great importance for monitoring and detection of substandard (quality defect), and especially falsified medicines.