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 impacts pharmaceutical manufacturers and regulatory bodies responsible for overseeing drug production. It aims to guarantee the safety and efficacy of medicines available to the public.