According to the Law on medicines, the Institute for medicines and medical devices shall set maximum prices for medicines for human use and in accordance with the criteria determined by the Government in the Decree on the criteria of setting maximum prices of medicines.

Methodology of international price referencing (IPR) is used to calculate maximum prices of medicines, which is most commonly used methodology in EU Member States.

Reference countries used for setting maximum prices of medicines in Montenegro are the following:

Republic of Serbia
Czech Republic
Romania

If it is not possible to determine a comparable wholesale price based on data from reference countries, an EU Member State with the lowest comparable price shall be taken as reference country, in which a medicine is manufactured, or authorised for marketing.

Based on the criteria determined in the Decree, the Institute shall set maximum wholesale prices of medicines that are prescribed and dispensed at the expense of mandatory health insurance in Montenegro. Maximum prices shall be set for medicines that are on the Reimbursement List of Medicines, as well as for medicines approved by the Ministry of Health in accordance with the Law. Maximum prices may also be set for medicines for which application for including in the Reimbursement List of Medicines is to be submitted.

Marketing authorization holders and wholesale authorisation holders are obliged to submit to the Institute the application for setting maximum price of a medicine, or its alignment, in accordance with the Instruction on the manner of submitting application and documentation for setting maximum price of a medicine.

In accordance with provisions of the Decree, the Institute shall publish set maximum prices of medicines.

Report on set maximum prices of medicines (updated 27.3.2024.)

*Please be informed that the report is updated with prices set on the basis of the application for alignment in such manner that the last set price for a certain medicine is shown.

Previously published reports on set maximum prices of medicines may be found in the Archive of reports.

Instructions

Instruction on the manner of submitting application and documentation for setting/alignment of maximum price of a medicine (updated 12.3.2024.)

Form

Form for the manner of submitting application and documentation for setting/alignment of maximum price of a medicine

Archive of reports

Report on set maximum prices of medicines (updated 9.1.2024.)

Report on set maximum prices of medicines (updated 28.12.2023.)

Report on set maximum prices of medicines (updated 2.11.2023.)

Report on set maximum prices of medicines (updated 13.9.2023.)

Report on set maximum prices of medicines (updated 16.8.2023.)

Report on set maximum prices of medicines (updated 25.7.2023.)