Marketing authorisation for veterinary medicinal products
In the Republic of Croatia, only veterinary medicinal products holding a valid marketing authorisation may be placed on the market; the authorisation must be issued
in accordance with Regulation (EU) 2019/6 and the Act NN 2026/69.
Applications for a marketing authorisation for a veterinary medicinal product are submitted to the European Medicines Agency (EMA)
where they concern a marketing authorisation under the centralised marketing authorisation procedure
laid down in Articles 42 to 45 of Regulation (EU) 2019/6.
Applications for a marketing authorisation for a veterinary medicinal product are submitted to the Croatian Veterinary Institute (CVI)
where they concern a marketing authorisation under any of the following procedures:
- the national procedure laid down in Articles 46 and 47 of Regulation (EU) 2019/6 and Articles 11 and 12 of the Act NN 2026/69
- the decentralised procedure (DCP) laid down in Articles 48 and 49 of Regulation (EU) 2019/6
- the mutual recognition procedure (MRP) laid down in Articles 51 and 52 of Regulation (EU) 2019/6
- the subsequent recognition procedure (SRP) laid down in Article 53 of Regulation (EU) 2019/6.