Marketing Authorisation

Our services in the field of marketing authorisation of medicinal products essentially include

Marketing authorisations / Articles 8(3) and 19 (a, b, c) of Regulation 2001/83EC)

  • Centralised and decentralised European marketing authorisation procedures (CP, DCP / MRP, NP)
  • Variations
  • National phase, translations
  • Product information texts
  • Communication with national authorities
  • Advice on authorisation strategy

Submissions

  • Document review
  • Submission
  • Defect processing

Alert management in the NMVS

  • Alert management
  • Contract initiation with the required providers
  • Trouble shooting

IFA notifications (PZN)

  • Customer registrations
  • PZN new admissions
  • Price changes