Regulatory services
in Hungary

The Hungarian pharmaceutical sector has both a good infrastructure and skilled local workforce. The regulatory procedures, however, present a significant challenge for both new entrants and established competitors in the Hungarian healthcare market.

Significant and continuing budgetary pressures in the Hungarian healthcare market mean that delays within the regulatory process for more complex submissions are commonplace. Differing procedures for drugs, herbal medicines, medical devices and food additives, nutritional products and cosmetics, for example, and variations in requirements within each product category, add levels of complexity to an already complicated regulatory system. New entrants able to draw on the knowledge and insight of consultants working with the regulatory affairs and regulatory submissions across all product areas on a day-to-day basis will benefit significantly from this.

As your local regulatory partner Grove has access to the key institutions involved in regulatory affairs in the country, notably, the National Institute of Pharmacy and Nutrition (OGYEI) and OEP (the National Health Insurance Fund).

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

REGULATORY CONSULTING IN HUNGARY – 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 specific to the Hungarian market
  • Preparation and submission of relevant documentation for drug registration and marketing authorization
  • Medical device registration
  • 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

REGULATORY SERVICES IN HUNGARY – MAINTENANCE OF REGULATORY APPROVAL/MA

Grove’s in-country regulatory affairs team provide 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 IN HUNGARY – MONITORING OF LOCAL REGULATORY REQUIREMENTS

Completing the full-service regulatory package that Grove’s regulatory affairs consulting team in the Hungarian market 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