National Marketing Authorisation – New Application flow chart

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