Guideline for the Naming of a Medicinal Product
This guideline is intended for applicants/marketing authorisation holders (MAHs) as a guide for the creation of proposal of the name of a medicnal product in line with the current legislation for medicinal products in the Republic of Croatia. It applies to medicinal products authorised by the Agency for Medicinal Products and Medical Devices (HALMED) via either purely national procedure (NP) or mutual recognition (MRP) or decentralised procedure (DCP) for granting marketing authorisation.
The guideline for the naming of a medicinal product version 2.0 is available here.
