Regulatory services
in Estonia

Since its accession to the EU, the small size of the Estonian market has encouraged rapid harmonization with EU regulations within the healthcare area. There are no country-specific requirements for marketing authorization applications, with the country following EU-regulations in this respect. Furthermore, with Estonia pushing electronic reporting and communication hard, marketing authorization holders have been able to benefit from utilizing e-communication when submitting applications for marketing authorizations and when informing the regulatory authorities with regards to variations and renewals, for example.

As your local regulatory affairs partner Grove has access to the key institutions regulating the market, notably, the State Agency of Medicines (SAM) and the Ministry of Health.

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

REGULATORY CONSULTING IN ESTONIA – 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 affairs consulting - regulatory submissions and registration related services
  • 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 ESTONIA – 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 ESTONIA – MONITORING OF LOCAL REGULATORY REQUIREMENTS

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