Authorisation And Review Of Medicine Prices

Ministerial Order 394/2025/1 of 14 November was published in order to define the reference countries to be used in 2026 and the exceptional criteria to be applied in the review of the prices of medicines.

Reference countries for new prices and for the annual price review

The reference countries for the approval of new prices and the annual price review of medicines (outpatient and hospital market) will continue to be Spain, France, Italy, and Belgium.

Criteria to be observed in the Annual Review of Medicine Prices (APR)

Outpatient market (non-generic and non-biosimilar medicines)

Hospital market (non-generic and non-biosimilar)

Outpatient and hospital market (generic and biosimilar medicines)

All generic and biosimilar medicines are exempt from the APR, except for generic medicines with a maximum price higher than the maximum price of the reference medicine resulting from the 2026 APR. In this case, the maximum price of the generic medicine cannot exceed the maximum price of the reference medicine.

Critical medicines

Medicines included on the list of essential critical medicines, which are dispensed in the outpatient market, are exempt from APR.

Deadlines for marketing authorisation holders or their legal representatives to submit the prices to be applied in 2025:

• Annual review of the maximum retail price of non-generic medicines:  By 15 December 2025, with prices taking effect on 1 January 2026
• Annual review of maximum retail price for generic and biosimilar medicines:  By 15 January 2026, with prices taking effect on 1 February 2026

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.