Overview

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. To guide you through the end-to-end HALMED regulation requirements, Freyr is capable of:

Freyr Offerings

EU compliance

  • Consultation expertise: regulatory solutions, strategic planning.

Regulatory affairs for pharmaceuticals

  • Licensing support
  • Dossier submission review and ensuring strict regulatory standards are met
  • Consideration of EU regulatory requirements 
  • Responding to regulatory agencies’ questions
  • Patient Information Leaflet and Summary of Product Characteristics services
  • Advertising review
  • Pharmacovigilance and safety issues.

Regulatory affairs for medical devices

  • Classification support
  • Registration support (activity, medical devices)
  • Support in development, product description, preparation of technical documentation
  • Consideration of EU regulatory requirements
  • Responding to competent authorities questions
  • Labelling and instruction of use services
  • Vigilance and safety issues
  • Post-marketing surveillance

Freyr Advantages

  • High-level agency contacts with HALMED
  • Expert Regulatory team
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market