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 correspondence@noma.no
  • Please do not use the e-mail address correspondance@noma.no for any other communication with NoMA
  • For e-mail addresses used as contacts for applications, an out-of-office reply should not be used

Delivery options

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.

CESP

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

eSubmission Gateway

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

Eudralink/e-mail

Submissions by Eudralink or e-mail may be used. For new applications, use the e.mail address post@noma.no. 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

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

CD/DVD

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.

International standards

The Norwegian Medicines Agency refer 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 authorisation applications. From 2018, it will be mandatory for all submissions in DCP/MRP.

For veterinary products, VneeS is obligatory for all applications in CP, DCP and MRP.

For the national procedure, eCTD and VneeS will become mandatory for initial marketing authorisation applications from Q3 2018, and for all applications from 2019.

When transferring to eCTD a baseline is highly recommended, but not obligatory. A baseline can also be submitted later in the life cycle. The baseline should preferably consist of high quality electronic source documents, but good quality scanned images would also be acceptable, preferably with Optical Character Recognition (OCR) to facilitate text searching. A baseline would typically consist of the Module 3 documents that tend to change over time during the lifecycle of the product.


Please contact post@noma.no if you have any questions.

For more information:
http://esubmission.ema.europa.eu/whatisesubmission.htm
http://www.hma.eu/277.html

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