Electronic applications

eCTD (Electronic Common Technical Document)

A European standard for basic information (Module 1) was issued in July 2004. A standard for Modules 2-5 (eCTD) is identical for the European Economic Area (EEA), the United States, Canada and Japan.

Reference is made to the EMA website

Electronic Application Form

A European standard for electronic application forms was issued in July 2004.

IMA uses same criteria for technical validation of Module 1 for eCTD as EMA.

Submission of product information

The IMA highly recommends that Marketing authorisation holders update SmPCs, PIL and LAB documents from the old Microsoft Office files formats (i.e. doc, xls, ppt) to current formats i.e. docx, xlsx or pptx before submission. Submission of old formats can lead to security issues and several NCAs no longer accept the old Microsoft Office files, outdated since version 2007 (i.e. doc, xls, ppt) or new Microsoft Office files with extensions (i.e. docm, xlsm, pptm).

Veterinary medicinal products

Regarding eSubmissions the IMA refers to EMA's eSubmission site.

Last updated: November 21, 2023
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