STELLAPHARM ACHIEVED CROATIAN – GMP CERTIFICATION

On July 18, 2025, STELLAPHARM J.V. Co., Ltd. – Branch 1 achieved the EU – GMP (Good Manufacturing Practice) certification issued by the competent authority, the Croatian Agency for Medicinal Products and Medical Devices (HALMED) and the information is published on the EudraGMDP database of the European Union. Achieving this certification not only enhances the position of the STELLAPHARM brand in European but also serves as an important foundation for the company’s development strategy.

About HALMED: HALMED’s key role in Croatian and EU GMP supervision

The Croatian Agency for Pharmaceuticals and Medical Devices (HALMED) is the national competent authority responsible for medicinal products and medical devices in Croatia. HALMED plays a key role in granting Manufacturing and Import Authorisations (MIA) and Good Manufacturing Practice (GMP) certificates to pharmaceutical manufacturers in and outside Croatia. This allows HALMED to carry out GMP supervision in Croatia and third countries, and to grant internationally recognised GMP certificates.
HALMED’s mandate and recognition extend beyond Croatia’s borders due to its integration into the wider EU inspection system; HALMED is part of the European Medicines Regulation Network (EMRN) and HALMED successfully joined the Joint Inspection Programme (JAP) in 2016. Notably, the US Food and Drug Administration (FDA) recognized Croatian GMP inspections in 2017, further strengthening HALMED’s international standing. Information on issued manufacturing and import licenses, as well as GMP certificates, are all published on HALMED’s website and are also entered into the EudraGMDP database, an EU central database of GMP information for reference.

Thus, the EU-GMP certificate granted by HALMED is not only valid within the EU but is also recognized in countries that have signed Mutual Recognition Agreements (MRAs) with the EU such as the US and Canada, allowing the manufacturers to supply their products to those large markets.