New application forms mandatory from 1 January

14 December 2015

From 1 January 2016, it will be mandatory to use the eAF to apply for marketing authorisations, renewals and variations. This applies to both human and veterinary medicinal products, and it applies to all procedure types.

From 1 January 2016, it will be mandatory to use eAF for all applications for marketing authorisations, variations and renewals in the pharmaceutical area. This means that the previous Word-based application forms will be discontinued.

The change applies to both human and veterinary medicinal products and to all approval procedures: the centralised, decentralised, national and mutual recognition procedures.

Since July 2015, eAF has been mandatory for applications under the centralised procedure, and at present it is also possible to use eAF for the other procedures.

eAF stands for ”electronic Application Form”. It is a PDF form with, among other things, the following features:

  • eAF only displays relevant sections, depending on previous selections.
  • Data in drop-down menus are extracted from a central database of controlled terms.
  • The form has an inbuilt function, which validates e.g. that all mandatory fields have been filled in. This validation is not complete, but helps applicants to fill in the form correctly.
  • Data from the form is stored in a structured way so that authorities can use the data in automated processes.
  • Applicants can also use structured data from the form to copy data from one form to another.

Read more about eAF and get more information about the forms

eAFs that are submitted electronically must be locked by uploading an image file to prevent any subsequent changes.

Please note that the use of eAF does not have any impact on the Danish Medicines Agency’s format requirements. The eAF is simply a new template. The application form should be part of the application in the same way as previously.

Unfortunately, it has not been possible to enable the ”Fast Web View” option. For human submissions, this will generate a warning (16.BP5 for eCTD and 3.BP4 for NeeS) when performing technical validation. The warning can be ignored for eAF.

Special notes on paper applications

It is still possible to submit a paper application. As always, we must receive a full application on paper. This means that you should print and sign the filled in eAF before you send it. Please check the eAF by using the validation function, but print the form without having locked it. This will ease our scanning and OCR processing of the application form.

If you enclose a complete copy of the application on CD/DVD with the paper application, please make sure that the electronic application form is locked.

If you have any questions as to the introduction of eAF, please write to the Danish Medicines Agency at esubmission@dkma.dk

Links

EMA’s information on eAF

About eSubmission Roadmap

Format requirements

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