Regulatory Affairs

RegInfo could support you in the following fields:

  • Assistance with marketing authorization applications in Hungary (national, MR or DC procedures) – new MA applications, variations, renewals
  • Product information update
  • Review of artworks in line with the marketing authorization and appropriate local legislation
  • Managing of Braille Certificates
  • MA transfers
  • Submission of Final Sample Permission
  • Submission of Formal defect permission - allowed differences from the Marketing Authorization
  • Notification of Temporary discontinuation of sale (shortage) to the Hungarian authority
  • De-registrations
  • CMC documentation
  • Assistance for communication with local Regulatory Authority
  • Communication via electronic company gateway
  • Information and interpretation of national requirements, screening regulatory authority websites
  • Obtaining of a Certificate of a Pharmaceutical Product – and its legalization if necessary