Pravilnik o uvjetima za davanje proizvodne dozvole, zahtjevima dobre proizvođačke prakse te potvrdi o provođenju dobre proizvođačke prakse za lijekove

This regulation sets out the conditions for obtaining a manufacturing authorisation for medicinal products. It details the requirements for Good Manufacturing Practice (GMP) and the certification process to ensure medicines meet high quality and safety standards. This affects pharmaceutical manufacturers and importers, ensuring compliance with EU standards for drug production and distribution within Croatia.