Electronic application forms
Electronic Application Forms (eAF) are mandatory in all procedures for initial marketing authorisations, variations and renewals.
The forms and more information are available from EMA: http://esubmission.ema.europa.eu/eaf/index.html
Please note that the eAFs gradually will be replaced by the new Common European Single Submission Portal (CESSP). More information will be announced by EMA: http://esubmission.ema.europa.eu/cessp.htm
NoMA’s electronic workflow system
Since December 2013, NoMa has used an electronic workflow system in which data are automatically imported from the eAFs. Applicants are asked to ensure that all data are correct before submission. We ask you to pay particular attention to the following:
- All Norwegian MAA-numbers have the correct format (e.g.17-12345)
- A billing address has been filled in when possible
Automatically generated e-mail
Please respond to all e-mails from NoMA as specified. This is of particular importance as e-mails are automatically generated by the system. Please note the following:
- Please do not respond to e-mails that are marked “Do not reply”
- You may forward e-mails to so that others can reply
- You should not modify the subject field of the e-mail (abbreviations such as VS: or FW: do not have to be removed)
- You can reply only once to an automatically generated e-mail from email@example.com
- Please do not use the e-mail address firstname.lastname@example.org for any other communication with NoMA
- For e-mail addresses used as contacts for applications, an out-of-office reply should not be used
The preferred delivery option is the current European submission platform CESP.
Please use only one delivery option when submitting a new application or other types of documentation such as ASMF or veterinary PSURs.
A scanned or wet signature on the application form or cover letter is not required.
Applicants are asked to use CESP for DCP/MRP and national applications, for veterinary products in CP and other types of documentation such as Active Substance Master Files, clinical trials and veterinary Periodic Safety Update Reports.
To register and for further details on how to use this platform please see the HMA website: http://cesp.hma.eu/Home
For CP, the eSubmission Gateway/eSubmission Web Client is obligatory for all eCTD submissions for human medicines. For more information: http://esubmission.ema.europa.eu/esubmission.html
Submissions by Eudralink or e-mail may be used. For new applications, use the e.mail address email@example.com. For additional e-mail addresses and contacts: http://www.hma.eu/69.html
Please reply to e-mails from NoMa as specified, as they may be part of NoMA’s automated workflow system.
When using Eudralink, please set the expiry date to at least 40 days.
PSUR Repository is mandatory for all documents in relation to Periodic Safety Update Reports (PSUR) for human products. For more information: http://esubmission.ema.europa.eu/psur/psur_repository.html
Submissions can be made by CD/DVD. One copy is sufficient. Please include a cover letter on paper to facilitate the identification of the content.
The Norwegian Medicines Agency refers to international standards when it comes to requirements to electronic formatting of electronic submissions: eCTD or NeeS for human products and VneeS for veterinary products.
In CP, eCTD is mandatory for all application types. In DCP/MRP, eCTD is mandatory for initial marketing autorisation applications. From 2018, it will be mandatory for all submissions in DCP/MRP.
For veterinary products, VneeS is obligatory for all applications.
For the national procedure, NoMA has not yet set a date for obligatory transition to eCTD or VneeS. Please contact firstname.lastname@example.org for any questions about individual submissions.
For more information: