Flowchart of the national procedure in case of new application.
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Day 0: the procedure starts with the submission of the application
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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
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As soon as the supplementary documentation is submitted the clock will be restarted
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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
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If necessary the applicant may ask for more time – this means that the procedure will be suspended, the clock will be stopped
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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)
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If the documentation is not appropriate the National Institute of Pharmacy will refuse the application in a decision
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Day 210: issuing the Marketing Authorisation
