On February 12, 2026, the Ministry of Health published Exempt Decree No. 9, which amends Technical Standard No. 136, “Determining the active ingredients contained in pharmaceutical products that must demonstrate therapeutic equivalence” (“Decree No. 9”). As a result, the bioequivalence requirement is extended to 99 new active ingredients, and mandatory deadlines of 24 and 36 months are established for submitting proof of bioequivalence to the Institute of Public Health.

In this regard, our Life Sciences team has prepared a detailed report, which you can access by clicking here.