Medicinal Products

Preparation, Submission and Archiving of Dossiers for Medicinal Products

Guidelines for the introduction of electronic dossier in eCTD format submitted in national procedures ("purely NAP" in Croatia) are intended for applicants/marketing authorisation holders as a guide for preparation and submission of electronic dossiers for medicinal products, and are aligned with the Heads of Medicines Agencies (HMA) strategy for the introduction of electronic submission of regulatory requirements in the European Union.

Instructions for submitting dossiers for medicinal products in paper format may be used by applicants/marketing authorisation holders for dossier preparation and submission only in national procedures in which the marketing authorization is given only in the Republic of Croatia ("purely NAP") until December 31, 2019, following which the eCTD format of dossier will be mandatory required.

Here you can find a guideline "Best Archiving Practice Guidance" along with the accompanying specification for longterm archiving of the electronic dossier.

For all enquiries or technical issues associated with electronic submission please send email to: