Obligation to submit a variation application following PSUSA procedure
12.12.2025
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 the Medicinal products/ Variation applications - referrals, PSUSA procedures and PRAC signals/ Instructions for variation applications following the outcome of the PSUSA procedure section on the HALMED's website.
The table is updated with the PSUSA outcomes for the following active substances:
- levetiracetam
- bisoprolol / hydrochlorothiazide
- ciclosporin (systemic use)
- botulinum neurotoxin type a (150 kd) free from complexing proteins
- dexketoprofen / tramadol
- testosterone (all formulations apart from topical use)
- bosentan
- bupropion
- botulinum toxin a (except for centrally authorised products)
- prednisone
- dorzolamide
- atenolol
- gabapentin
- codeine
- caspofungin
In accordance with Art. 50 of the Medicinal Products Act (OG 76/13, 90/14, 100/18 and 136/25) and Art. 16 of Regulation (EC) No 726/2004, marketing authorisation holders are required to ensure that the information on the medicinal product is in line with the latest scientific knowledge. In cases where the outcomes of the PSUSA procedure require a regulatory procedure, such as the introduction of new information in the Summary of Product Characteristics (SmPC) and the Package Leaflet (PL), marketing authorisation holders are required to submit a variation application.
The PSUSA procedure number should be stated in the variation application.
