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 Notification

  • 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

  • Obtaining approval for Direct Healthcare Professional Communication (DHPC)

  • Additional Risk Minimisation tools (e.g. Educational Materials)