As a smaller pharmaceutical market, the Nordic region understands the importance of collaboration between countries for a successful product launch. While the Nordic countries – comprising Sweden, Norway, Denmark, Iceland, and Finland — adhere to global standards and the various European Union rules around the development and launch of a product, there are country-specific steps companies must take to successfully enter the Nordic market.
During a recent webinar, experts in compliance requirements, regulatory activities, quality and distribution, and market and patient access shared their insights on how to navigate the Nordic market.
Managing quality and distribution
Nordic countries present some geographic challenges, so choosing the right supply chain strategy and the right transportation methods is essential. Companies should plan their distribution strategy carefully considering product type, target market, operational capacity, and potential risks.
While compliance with European Good Distribution Practice (GDP) guidelines[i] is important for having control over the distribution, quality and integrity of medicinal products, companies must understand country-specific differences.
Companies should set aside time to plan and apply for required licenses and authorizations. Products must be imported into the EU market and batch certified by an EU qualified person (QP)[ii]. Additionally, there are local differences and requirements regarding product safety, stock requirements, and shortage management.
An agile, fit-for-purpose quality management system (QMS) will be integral to managing local versus regional and global regulations and supporting business strategy.
Building compliance across the Nordics
Nordic countries adhere to international EU rules and standards for the promotion of products[iii],[iv];; however, there are also local marketing laws, EFPIA association codes, and interpretations of the guidelines.
The local agencies oversee adherence to these requirements and can sanction companies that violate local codes. Sanctions can include fines and notifications to change the material[v].
It’s important that companies understand the requirements and definitions in the local markets, such as how each country defines a healthcare professional since it is only permissible to market prescription-only medicines to HCPs.
Each market also has slight differences when it comes to pre-launch activities. For example, in Denmark it depends on the phase of clinical studies whether information is acceptable to share. In Sweden, pipeline information is not allowed in commercial contexts. In non-commercial contexts a general overview is permitted under certain circumstances[vi]. There are also country-specific requirements around the abbreviated product information (API) text, black triangle specifications, substantiation of safety and efficacy claims, and what is permitted with events and hospitality.
The regulatory steps to a successful launch
Cross-functional communication is at the heart of a successful launch for any market. That includes taking into consideration the needs of different markets, such as the availability and usability of the product and the length of the marketing authorization application process.
Among factors that can influence this at a local level are environmental risk assessment, pack sizes, translations and artwork. One way the Nordic market is seeking to address some of these challenges is through a common Nordic package, which would help to reduce costs and packaging waste and enhance the availability of medicines. This would require a harmonized packaging insert and commonality with regard to trade name, strength and pharmaceutical form[vii]. Ways to tackle challenges around a common package include multilingual packaging[viii], modified country combinations, and package insert documentation harmonization.
In 2025, the Nordic agencies are launching a five-year pilot program for critical hospital use medicinal products. During the pilot, so-called common Nordic packages labelled in English only will be tested to investigate whether certain critical small-volume products could be exempted from the current language requirements for labelling and package leaflets[ix].
To navigate these finer country nuances, companies should have on-the-ground expertise on the local marketing regulations in each of the Nordic countries, set up robust processes for approval of materials and activities, and be prepared to start preparing their materials well in advance.
Planning market and patient access activities
To successfully navigate the route to market and patient access, companies need to understand that the Nordics are separate regions with regards to both the therapeutic landscape (treatment guidelines, relevant comparators, etc.) and the health technology assessment (HTA) process – from timing of submission to evidence requirements to evaluation criteria.
The type of assessment will depend on factors such as the treatment landscape (what is the comparator) as well as efficacy and cost relative to the comparator.
Consequently, target pricing and probability of reimbursement for a given therapy can vary across the Nordic countries.
To smooth and shorten the process, companies should be clear about the submission timeline and evidence requirements. It’s important to know whether key opinion leader input on clinical practice and unmet need will be required or, for example, if complementary data sources are required, such as real-world data.
To better manage the reimbursement process, companies should have any required information to hand, such as a health economic model, a budget impact model and systematic literature review, which are requirements in Norway[x]. In Denmark, these steps are required for the Danish Medicines Council process which mainly reviews hospital drugs and high profile or very costly drugs[xi].
A best practice for preparing should include:
- Mapping the local market, including the treatment landscape, routes to market, dossier requirements and potential implications for the overall strategy
- A gap analysis of the clinical trial and health economic inputs
- Early phase modelling
- Complementary studies
Being ready for the Nordic market
The Nordics are a small market; however, collectively the population is nearly 28 million[xii]. Additionally, the Nordic region is committed to innovation and cooperation and to working collaboratively based on shared values, similar cultures and mutual trust.
[i] Good distribution practice, EMA. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/compliance-post-authorisation/good-distribution-practice
[ii] Annex to the Guide to Good Manufacturing Practice for Medicinal Products: Certification by a Qualified Person and Batch Release, European Commission. https://health.ec.europa.eu/document/download/0d97da0d-ea5d-4920-a0d0-5dd1e99070ac_en?filename=gmpbr_200001_en.pdf
[iii] Code of practice, Upholding ethical standards and sustaining trust, IFPMA. https://www.ifpma.org/wp-content/uploads/2018/09/2023_IFPMA-Code-Interactive.pdf
[iv] The EFPIA Code of Practice. https://www.efpia.eu/relationships-code/the-efpia-code/
[v] Code of practice, The Ethical Committee for the Pharmaceutical Industry in Denmark (ENLI). https://www.ifpma.org/wp-content/uploads/2022/12/LIF-Code-of-Practice.pdf
[vi] Nordic Compliance – overview, November 2024. Exhibitions (enli.dk)
[vii] Packaging of medicinal products. https://www.dmp.no/en/approval-of-medicines/approval-and-follow-up-of-marketing-authorisation-ma/Product-information—templates-and-guidance/packaging#Nordisk-merkingssamarbeid-175759
[viii] CMDh Best Practice Guide on Multilingual Packaging, June 2024. https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/CMDh_413_2019_Rev.5_2024_06_clean_-_BPG_on_MLP.pdf
[ix] Pilot project on English-only common Nordic packages for human medicinal products, Dec 2024. https://laegemiddelstyrelsen.dk/en/licensing/licensing-of-medicines/spcs,-package-leaflets-and-labelling/pilot-project-on-english-only-common-nordic-packages-for-human-medicinal-products/
[x] Submission guidelines For Single Technology Assessment of Medicinal Products, Norwegian Medical Products Agency. https://www.dmp.no/globalassets/documents/offentlig-finansiering-og-pris/dokumentasjon-til-metodevurdering/submission-guidelines-april2024.pdf
[xi] The Danish Medicines Council methods guide for assessing new pharmaceuticals. The Danish Medicines Council methods guide for assessing new pharmaceuticals version 1.2 (b-cdn.net)
[xii] Population in the Nordic countries from 2000 to 2024. https://www.statista.com/statistics/1296240/nordics-total-population/
