We would like to inform all marketing authorisation holders and wholesale authorisation holders that the Decree on the criteria of setting maximum prices of medicines (“Official Gazette of Montenegro” No 130/21 and 9/22) has been amended and that the Amendment to it was published on 7 March 2024 in the “Official Gazette of Montenegro” on 7 March 2024.

Previously set maximum prices of medicines are required to be aligned due to the change of reference countries, as well as the prices of medicines in them.

CInMED will start receiving the applications for setting/alignment of maximum prices of medicines and the required documentation when the Decree enters into force, i.e. on 15 March 2024. It is necessary to submit the required documentation along with application, in line with the Instruction on the manner of submitting application and documentation for setting/alignment of maximum price of a medicine, that is available on the CInMED portal in the section Human medicines/Maximum prices of medicines/Instructions, or here.

The deadline for submitting the documentation is 90 days.