Changes to the Composition of the Medicines Pricing Commission and Procedures for Setting and Declaring Medicine Prices
Official Gazette No. 64, dated March 27, 2026, has published and brought into force Decision No. 198, dated March 26, 2026, of the Council of Ministers, titled: “On certain amendments and additions to Decision No. 645, dated October 1, 2014, ‘On the establishment and functioning of the Medicines Pricing Commission,’ as amended.”
This Decision introduces a series of changes to the organization and functioning of the Medicines Pricing Commission, as well as to the procedures for determining medicine prices in the Republic of Albania. Specifically, the composition of the Commission has been amended by increasing the representation of the Ministry responsible for health from one to two members. The method for comparing prices has also been revised, now based on CIF prices of the reference countries - Italy, Greece, Serbia, North Macedonia, and Croatia - replacing the previously used wholesale prices. At the same time, the methodology for determining the reference price has been modified. Unlike the previous provision, which was based on the lowest price applied among the five reference countries, the new rule establishes that the reference price will be calculated as the average of the three lowest prices applied among these countries.
The Decision also revises procedural deadlines. The deadline for price declarations by the marketing authorization holder or its legal representative has been moved from October 31 to September 30 each year. The deadline for notification by the Ministry responsible for health regarding price declarations has been shifted from September 30 to September 1, and the date for the Commission’s meeting to open the submitted price envelopes has been moved from November 5 to October 5 each year.
Additionally, the Decision expands its scope of application to include biosimilar medicines alongside generic medicines. Finally, the Decision stipulates that the Medicines Pricing Commission must carry out a reassessment of the approved prices for 2026 within 10 days from its entry into force.
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