Regulatory Authority

Norwegian Medicines Agency

Link for Regulatory Authority

https://www.legemiddelverket.no/English

Local Authorised

Yes

Registration Timeline  

Up to 210 days for mutual recognition procedure.

Registration Fee

https://www.dmp.no/globalassets/documents/godkjenning/godkjenning-av-legemidler/registreringsgebyr/oversikt-over-nye-gebyrer—engelsk-versjon-2022—endelig-til-nettsidene_21012022.pdf

License Validity

5 Years

Submission of Applications

To submit applications to NoMA (Norwegian Medicines Agency),

• Electronic application forms (eAF): eAFs are mandatory for all procedures related to initial marketing authorizations, variations, and renewals. The forms and more information can be found on the EMA website: EU electronic application forms.
• 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 must ensure that all data are correct before submission. Particular attention should be paid to the following:
• All Norwegian MAA-numbers should have the correct format (e.g. 17-12345)
• A billing address should be filled in when possible
• Automatically generated e-mail: Applicants should respond to all e-mails from NoMA as specified. The following points should be noted:
• Do not respond to e-mails that are marked “Do not reply”
• E-mails can be forwarded to others to reply
• The subject field of the e-mail should not be modified (abbreviations such as VS: or FW: do not have to be removed)
• An automatically generated e-mail from correspondence@noma.no can only be replied to once
• The e-mail address correspondence@noma.no should not be used for any other communication with NoMA
• For e-mail addresses used as contacts for applications, an out-of-office reply should not be used.
• It is important to follow these guidelines to ensure a smooth and efficient application process with NoMA.

The Norwegian Medicines Agency (NoMA) offers several delivery options for submitting applications and other types of documentation.

1. CESP (Common European Submission Platform): 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.
2. eSubmission Gateway: For CP, the eSubmission Gateway/eSubmission Web Client is obligatory for all eCTD submissions for human medicines. For more information: eSubmission Gateway.
3. 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 atleast 40 days.
4. 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.
5. 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 Medical Products Agency refers to international standards when it comes to requirements for electronic formatting of electronic submissions: eCTD for human products and VNeeS for veterinary products.

From 2019, eCTD and VneeS are mandatory also in national procedures. 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. For guidance, see Q&A on mandatory eCTD in National Procedures (NP), available at e-Submission 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.

For more information, please visit the eSubmission Home. If you have any questions, please contact post@noma.no.

Release Notes for the eSubmission Roadmap v2.2

Main updates compared to version 2.1

eCTD v4.0

eCTD v4.0 transition timeline was put in place earlier but is now on hold pending a review of the overall network-wide strategy and plan. The timeline will be re-confirmed after this aligned strategy is discussed and agreed upon. But the limited context makes it difficult to provide a more complete interpretation. More background information would help clarify the circumstances fully.

eGateway, CESP, eAF, Single Submission Portal

CESP implementation is proceeding in a phased manner from 2020-2021 for different application types. The mandatory single submission portal timeline is still to be finalized based on the broader network strategy. A common service desk will also be implemented incrementally through Q1 2021.

Other Updates

The roadmap document version 2.2 has also been updated to reflect the already achieved milestones (Done) and a few minor changes have been made, e.g. to include some reflections on current situation and the new veterinary legislation issues.