Quality & Compliance
Safety & Vigilance
19 september 2023
Regulatory affairs (RA) in the Nordic countries – Denmark, Finland, Iceland, Norway, and Sweden, have many similarities due to their shared membership in the European Economic Area (EEA) and close collaboration in healthcare regulation.
Moreover, as proof of good collaboration and harmonization of principles, safety standards, efficacy, and quality, the Nordic Pharmaceutical Forum was created in 2015. This collaboration was primarily thought to ensure timely and affordable access to new and old medicines for patients and create a framework and space for Nordic cooperation in pharmaceuticals. 
As each Nordic country represents a small market, the manufacture of Nordic packages has been agreed upon. As mentioned before, harmonization due to shared membership helps create Nordic packages. It is related to authorization type (CP, MRP, and DCP products – harmonization already exists, except for blue-box requirements). For pure national developments, the Nordic package option will depend on the grade of the dossier harmonization in the Nordic countries. 
The Nordic countries are frequently considered a potential single market for therapeutic products since, for example, blue-box requirements for inner packages are mostly the same (VNR, 2D barcode, etc.). All Nordic countries follow the Readability Guideline, the QRD template, and the excipients guideline, and the recommendation of these guidelines should be reflected in the labeling and PIL, together with the national requirements, which can be found on national authorities’ websites. 
Of course, when it comes to regulatory submissions, depending on the procedure type, some particularities can easily be found on National Authorities websites:
that national DK approval is obtained. Submission should be made as soon as DK approval is obtained
, and approval timelines are one month after submission.
At ProductLife Group we work in the Nordic market daily as well as global markets with over 1000 different clients. Our Danish presence not only provides us a firm understanding of the market but our personal contacts allow us to also support with complex requests. Trust PLG to support your existing portfolio of products in the Nordic market and consider us for your expansion activities. Contact us to learn more about how we can further support your products and company.
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