The purpose of this guide is to fully define the requirements of the Public Agency for Medicinal Products and medicinke devices (hereinafter JAZMP) technical validation for successful applications in the format e-CTD and NeeS.
Scope
Guidance should be used by applicants who apply on JAZMP role in electronic format or e-CTD NeeS.
E-CTD format or NeeS investors can apply for the following types of applications:
1st Authorisation Holder,
2nd Expansion of an existing permit holder,
3rd Renewal of Marketing Authorisation
4th Changes to the terms of marketing,
5th Periodic Safety Update Report (PSUR);
JAZMP accepts such types of applications for MRP, DCP, NP and CP procedures in human medicine for procedures for medicinal products for veterinary use and accept electronic applications in VNeeS format.
For More Information Please click here: JAZMP (Slovenian Agency) eCTD & Nee'S Updates
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