HALMED’s role
In accordance with the provision of the Medicinal Products Act (Official Gazette, No. 76/13, 90/14 and 100/18), HALMED is the competent body for:
- Issuing manufacturing authorisation
- Issuing certificate for the implementation of good manufacturing practice
- Inspection of good manufacturing practice
- Inspection of good pharmacovigilance practice
In accordance with the provisions of the Veterinary Medicinal Products Act (Official Gazette, No. 84/08, 56/13, 94/13, 15/15 and 32/19 (in Croatian)) HALMED is the competent body for:
- Issuing manufacturing authorisation
- Issuing certificate of fulfilling principles of good manufacturing practice for the manufacturing of veterinary medicinal products
- Inspection of the manufacturing of veterinary medicinal products
* Note: Upon the transposition of the European legislative framework into the national laws of the Republic of Croatia, on account of the allocated competencies of the two respective institutions (Ministry of Health, Ministry of Agriculture), various terms/translations of the same services in the area of manufacturing and inspection of medicinal products for human use and veterinary medicinal products were implemented within the legal system of the Republic of Croatia.
