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Regulatory services in Croatia

  • Writer: Freyr Global Regulatory Solutions
    Freyr Global Regulatory Solutions
  • Sep 19, 2017
  • 1 min read

Starting July 1, 2013, Croatia has become the official member of European Union (EU) with the Agency for Drugs and Medical Devices (HALMED) overseeing the Regulatory and compliance activities in the region pertaining to medicinal products and medical devices. Though the valuable efforts have been made to align the country’s registration requirements with that of the EU Directives, the fact that those have not yet been fully aligned might jolt the regulatory planning of new market entrants.

Freyr, being a specialist global Regulatory services provider, assists companies with the sustainable consulting for Regulatory affairs in Croatia. Freyr has the capability to act as a professional European Authorized Representative and can take ahead the Croatian medicinal product / medical device registration procedure for foreign / non-EU manufacturers.

 
 
 

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