H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.

MAGYAR

National Marketing Authorisation – New Application flow chart

Flowchart of the national procedure in case of new application.
  • Day 0: the procedure starts with the submission of the application
  • Validation letter (deficiencies of the documetnation) is sent to the applicant – the clock is stopped – the National Institute of Pharmacy provides 15 days for the applicant to submit the requested supplementary documentation – if the applicant do not replies in time the application will be refused by the National Insitute of Pharmacy in a decision
  • As soon as the supplementary documentation is submitted the clock will be restarted
  • Day 90: the comments concerning the documentation from the assessors are sent to the applicant – the applicant has to submit the response documents in 15 days - if the applicant do not replies in time the application will be refused by the National Insitute of Pharmacy in a decision
  • If necessary the applicant may ask for more time – this means that the procedure will be suspended, the clock will be stopped
  • The assessment of the documentation will be prosumed as soon as the response documentation is submitted (the clock will be restarted after the possible suspension)
  • If the documentation is not appropriate the National Institute of Pharmacy will refuse the application in a decision
  • Day 210: issuing the Marketing Authorisation
Last updated: 2008.08.19 11:12