Submission of applications

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: EU electronic application forms.

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 at this page.

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: CESP.

eSubmission Gateway

For CP, the eSubmission Gateway/eSubmission Web Client is obligatory for all eCTD submissions for human medicines. For more information: eSubmission Gateway.

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: CMDh Contact Points.

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: PSUR Repository.

International standards

The Norwegian Medical Products Agency refer to international standards when it comes to requirements to electronic formatting of electronic submissions: eCTD for human products and VNeeS for veterinary products.

From 2019, eCTD and VneeS is mandatory also in national procedure.

The change to eCTD format for a NP purely product dossier should normally be done at the start of a new regulatory activity, so ongoing procedures should be continued in the same format as the starting submission. Preferably, change to eCTD should not be done at the time of a PSUSA submission, even if this is the first new regulatory activity submission after 1 January 2019. For these submissions to the PSUR repository, non-eCTD is accepted until the dossier format is changed to eCTD at the submission of another new regulatory activity submitted to the NCA directly. For guidance, see Q&A on mandatory eCTD in National Procedures (NP), available at eSubmission eCTD.

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: eSubmission Home