Application for marketing authorisation
Published:
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Updated:
Changes
- : Removed information about delays and that mock-ups can be submitted within 2 months after granting of the MA.
- : The text has been written in more detail, and the content has been updated. The following paragraphs are new: Documentation, content, presentation and format. Assessment of the application, approval or refusal. Issuing of marketing authorisation
- : Added information about delays for MAs related to new case management platform
- : Removed information about the NoMAs new routine about also requiring labelling text to align with the Norwegian text.
A medicinal product may only be placed on the market in Norway when a marketing authorisation has been issued by the Norwegian Medicinal Products Agency. Requirements for applications and procedures for approval in Norway are identical to the EU`s.
Page contents
Documentation, content, presentation and format
The application consists of administrative information, expert reports and documentation of quality, safety and efficacy. A document showing that the manufacturer is authorised in his own country to manufacture the medicinal product must be attached. The applicant must submit proposal for the summary of product characteristics, package leaflet, and labelling.
The required documentation depends on the legal basis used for the application, for example the documentation requirements are more extensive and different for a full application compared to a generic application.
There are also different requirements for the content of an marketing authorisation (MA) application for human medicines compared to an MA application for veterinary medicines.
Detailed information, including EU legislation and guidance for applicants, is available on the European Commission's website Eudralex medicinal-products.
Information on electronic application form (eAF), and international standards, see Norwegian Medical Products Agency `s (NOMA) website Submission of applications for marketing authorisation.
Procedures for marketing authorisation applications
An application for marketing authorisation (MA) can be submitted in different procedures.
The National Procedure (NP) is used when a pharmaceutical company wants to get the medicinal product approved in one EU/EEA coutry. Read more about National procedure (NP)
The Mutual Recognition Procedure (MRP) is used when a medicinal product is already approved in the NP, MRP or DCP and the MA holder wants to get the product approved in additional EU/EEA countries. Read more about Mutual recognition procedure (MRP)
The Decentralised Procedure (DCP) is used by pharmaceutical companies to apply for MA in two or more EU/EEA countries simultaneously. Read more about Decentralised procedure (DCP)
The centralised procedure (CP) is mandatory for specific medicinal products. The applicant submits one application to the European Medicines Agency (EMA). Medicinal products approved by the CP are granted a MA that is valid in all EU and EEA countries. Read more about Centralised procedure (CP)
Regulatory fees
On NOMAs website it is available information on regulatory fees for the procedures NP, DCP og MRP.
See European Medicines Agency`s (EMA) website for Information on fees for the centralised procedure.
Assessment of the application, approval or refusal
The competent authorities shall assess the submitted documentation of regardless of the procedure. If the application meets the documentation requirements, the medicinal product will be approved. The application will be rejected if it is not documented that the medicinal product has a positive benefit- /risk balance of the applied indication or if other requirements are not met.
Issuing of marketing authorisation
If the medicinal product is approved, the NOMA issues marketing authorisation one for each strength and pharmaceutical form. The marketing authorisation specifies whether the medicinal product is prescription-only or not subject to medical prescription. The marketing authorisation gives the holder the right to place the medicinal product on the market in accordance with the authorisation. The MA holder must also comply with other relevant regulations.
Norwegian product information (summary of product characteristics, package leaflet and labelling) will be approved and attached when issuing a marketing authorisation
Important information regarding MAs in MRP and DCP
The Norwegian product information (summary of product characteristics (SmPC/SPC), package leaflet (PL) and labelling) will be approved with the marketing authorisation. Please submit the SmPC/SPC, PL and labelling as separate Word files and use the latest version of the QRD templates.
Human: Please submit the proposed final product information in Norwegian within 7 days after the End of Procedure.
Veterinary: If the product information is not received within a period of 6 months after the End of Procedure, the application will be considered to have been withdrawn.
If the medicinal product is to be marketed in Norway
If the medicinal product is to be marketed in Norway, mock-ups of the labelling must be submitted for assessment and approval by the NoMA, either within the MA procedure or as an Article 61(3) notification (human)/VRA G.I.15.z (veterinary). Mock-ups can also be submitted with a variation affecting the product information (type II variation for human medicinal products and VRA in chapter G for veterinary medicinal products). In order to obtain approval of mock-ups within the MA procedure, please submit mock-ups in the national phase. Mock-ups (in PDF-format) for each strength, pharmaceutical form and type of packaging intended to be marketed are required.
If the medicinal product is not to be marketed in Norway
If the medicinal product is not to be marketed in Norway, the marketing authorisation can be granted without the Norwegian product information (‘conditional’ MA).
Please send a confirmation within 14 days after the End of procedure to pi@noma.no. Variations following the MA procedure will also be approved without the Norwegian product information.
Please note that this option does not apply for line extension applications (human medicinal products) where the previously approved MAs are MAs with approved Norwegian product information.
Changes in marketing plans
If it is decided at a later stage that the product should be placed on the Norwegian market, the following must be assessed and approved by NoMA:
- SmPC/SPC
- PL
- labelling
- mock-ups
The Norwegian product information should be submitted two months prior to the planned marketing date.
Changes in the product information due to variation procedures approved after the MA procedure, must be implemented in the Norwegian product information (marked with tracked changes). Please list the variation procedure numbers and approval dates in the submission.