eSubmission of applications for marketing authorisation

Electronic application form (eAF)

The electronic application form (eAF ) is mandatory for all application for new marketing authorisation. The same applies for renewal and variation applications for existing marketing authorisations.

For new marketing authorisation application and renewals, use the version 1 forms available at the eSubmission websites of European Medicines Agency (EMA), under «eAF» in the left menu.

For variation applications for human medicinal products, it is recommended that version 2 forms are used (unless there is a good reason why version 1 must be used). These forms are filled in with information from SPOR and are available in the PLM portal. The link to this website can be found in the left menu on the same website as above on the eSubmission websites of European Medicines Agency (EMA)   

Submission methods

The submission method to be used depends on what procedure the application will follow. See details under the following subheadings.
An original or scanned signature on the application form or cover letter is not required.

CESP

CESP should be used for submission in MRP/DCP and national procedure, as well as for other types of submissions such as Active Substance Master Files, PSUR for veterinary products and clinical trials (many of the latter are available in CTIS). More information can be found at: Common European Submission Portal (CESP) 

eSubmission Gateway

For CP, EMA's eSubmission Gateway is mandatory for submissions for human and veterinary medicinal products. See EMA's website for more information: e-submission - European Medicines Agency (EMA)

Eudralink /email

Eudralink or e-mail can be used to submit applications (post@dmp.no ), but it is preferred that CESP or Gateway is used for submission of sequences in eCTD / vNeeS format. For other email addresses and contacts, see on the eSubmssion websites of European Medicines Agency (EMA)

PSUR Repository

All submissions related to Periodic Safety Update Reports (PSURs) for human medicines must be submitted via the PSUR Repository

International standards

The NOMA refers to current international standards for the formatting of electronic applications.

eCTD is mandatory for human medicines, VNeeS is mandatory for veterinary medicines.

The construction of eCTD and the completion of the .xml files are particularly important for the automated submission processes implemented in connection with Dele (new case management system) at NOMA. It is important that the applicable guidelines are followed.

From 2019, eCTD and VNeeS are mandatory also in national procedures. Transition to eCTD should occur at the first new regulatory activity, not in the middle of an ongoing procedure/activity. If PSUR / PSUSA is the first new activity in 2019, submissions to the PSUR Repository should continue in NeeS format, and transition to eCTD should occur at the start of the next regulatory activity. For guidance, see Q&A on mandatory eCTD in National Procedures (NP), available on EMA`s eSubmission page

When transitioning to eCTD, it is recommended to submit a baseline, but it is not mandatory. A baseline can also be submitted at a later date. It should include as much content as possible, with special emphasis on Module 3 with documents that change frequently over time. The files should be based on electronically produced documents. Good quality scanned files, preferably using OCR (Optical Character Recognition) so that free text search is possible, can also be accepted.

 If you have any questions, please contact post@noma.no 

More information about the formats can be found on EMA`s eSubmission pages