Regulatory services
in Croatia

Compared to the other Balkan markets, the Croatian regulatory system is relatively well-structured and predictable. Although there is considerable alignment in terms of regulatory affairs with EU legislation, idiosyncrasies peculiar to the Croatian market are evident with pharmaceutical legislation revolving around four key documents: the Medicinal Products Act, the Ordinance on Granting Marketing Authorizations for Medicinal Products, the Ordinance on Pharmacovigilance and Guidelines on Good Pharmacovigilance Practices.

As your local regulatory partner Grove has access to the key institutions regulating the market, notably, the Croatian Agency for Medicinal Products and Medical Devices (HALMED), the Croatian Institute for Health Insurance (CIHI) and the Ministry of Health.

Grove provides regulatory consulting services in Croatia in any one of a number of areas and can, if necessary, act as a full-service provider of regulatory services.

REGULATORY CONSULTING IN CROATIA – PRE-SUBMISSION AND SUBMISSION ACTIVITIES

With their comprehensive understanding of local regulatory requirements, Grove’s regulatory affairs consultants work closely with their clients through the necessary pre-submission and submission activities required. Key within this is:
  • Regulatory consulting - regulatory submissions and registration related services
  • Preparation and submission of relevant documentation for drug registration and marketing authorization
  • Liaison with local agencies to monitor progress
  • Assistance with packaging/labelling approval (packaging material submissions, labelling compliance/approval)
  • Readability testing for local language Patient Information Leaflets
  • Medical device registration

REGULATORY SERVICES IN CROATIA – MAINTENANCE OF REGULATORY APPROVAL/MA

Grove’s in-country regulatory affairs team provides a full support service post-submission, and work with clients in the following areas:
  • Post-marketing applications
  • Marketing authorization transfer services
  • Variations
  • Renewals
  • Notifications
  • Support for the management of national Agency databases
  • Submission of annual specific national declarations
  • Packaging/labelling compliance

REGULATORY AFFAIRS CONSULTING SERVICES IN CROATIA – MONITORING OF LOCAL REGULATORY REQUIREMENTS

Completing the full-service regulatory package that Grove’s regulatory affairs consulting team provide, Grove will:
  • Monitor local regulatory change and provide appropriate updates
  • Assess national regulatory documentation and provide appropriate updates
  • Ensure compliance with local regulatory requirements given any change in national legislation, regulations and policies
  • Provide relevant safety updates
Key product areas covered:
  • Pharmaceuticals/medicines/drugs/medicinal products
  • Medical devices
  • Biologics
  • Cosmetics
  • Food and dietary supplements