Obligation to submit a variation application following PSUSA procedure

Agency for Medicinal Products and Medical Devices of Croatia (HALMED) has published information on the outcomes of the PSUSA procedures, which include medicinal products authorised in the Republic of Croatia. Stated information is available in theMedicinal products/ Variation applications - referrals, PSUSA procedures and PRAC signals/ Instructions for variation applications following the outcome of the PSUSA proceduresection on the HALMED's website. The table is updated with the PSUSA outcomes for the following active substances: In accordance with Art. 50 of the Medicinal Products Act (OG76/13,90/14,100/18and136/25) and Art. 16 of Regulation (EC) No 726/2004, marketing authorisation holders are required to ensure that the information on