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. Individual EEA states can optionally request the application dossier to be submitted in paper form also.

Reference is made to the EMA website

Electronic Application Form

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

Nevertheless applicants must still submit a Cover Letter and the application signed by the applicant's representative.

IMA accepts both eCTD and NeeS electronic applications for MA. IMA uses same criteria for technical validation of Module 1 for eCTD as EMA.


Regarding NeeS applications the IMA refers EMA esubmission site on electronic application forms

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 (e.g. doc, xls, ppt) to current formats e.g. docx, xlsx or pptx before submission. Submission of old formats can lead to security issues and several NCA‘s no longer accept the old Microsoft Office files, outdated since version 2007 (e.g. doc, xls, ppt) or New Microsoft Office files with extensions (e.g. docm, xlsm, pptm).

Veterinary medicinal products

An electronic version of the application is preferable. Please note that notwithstanding Notice to Applicants, no documents have to be submitted in paper form.

The electronic version of the dossier shall be in accordance with "Guideline on E-submission of Veterinary Products" document. For further information see the "Frequently Asked Questions (FAQ) section for more information.

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