Medicinal Products

Preparation, Submission and Preservation of Documentation on Medicinal Products

Useful Information for Applicants - Documentation

Here you can find a new guideline for longterm preservation of the electronic Submissions under the name "Best Archiving Practice Guidance" with the accompanying specification. These documents have been published under the auspices of the EU Telematics Implementation Group - electronic submissions (TIGes), while the Agency for Medicinal Products and Medical Devices (HALMED) has participated in their preparation.

Here you can find instructions for applicants for submitting eCTD/NeeS dossiers for medicinal products (in Croatian).

Here you can find instructions for applicants for submitting the conventional dossier for medicinal products.

For TIGes Harmonised eCTD and NeeS guidance please refer to:
http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html

For all enquiries or problems associated with electronic submission please send email to: arian.rajh@halmed.hr.