Electronic Applications

eSubmission

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.

Further information on the standards and their implementation can be given by Gunnar Ásbjörn Bjarnason, CTO (gunnar.asbjorn.bjarnason@lyfjastofnun.is).

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

Use this template to change from paper submission to electronic submission.

NeeS

The electronic version of the dossier shall be in accordance with Guidance for Industry on Providing Regulatory Information in Electronic Format: Non-eCTD electronic Submissions (NeeS).

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.

January 2011