Pharmaceutical companies often want to streamline their marketing by creating one set of promotional materials for healthcare professionals (HCPs) across the Nordic countries. This helps to ensure a consistent message, reduce costs, simplify compliance management, and strengthen your brand identity.
While the regulations in the Nordic countries have many similarities allowing for common marketing materials for the region, they also differ in several ways due to local legislations. Managing the marketing regulations of multiple countries can be challenging.
This blog post discusses promotional material compliance in Finland, Sweden, Denmark, Norway and Iceland. See also our other blogs on promotional material compliance in the Baltics and in Finland.
Marketing in the Nordics – shared principles, local differences
All Nordic countries apply the EFPIA Code of Practice in addition to applicable national Codes, and expect promotional activities to be accurate, balanced and evidence-based.
The country-based differences include for example
- the allowed target audience – are nurses considered healthcare professionals?
- comparisons – what is accepted when comparing different products or active substances?
- the compulsory information of the product – the requirements vary greatly from Sweden’s short texts to Denmark’s long set of requirements.
Examples of Nordic rules on Rx marketing
In all of the Nordic countries, local authorities supervise the compliance of pharmaceutical marketing with local legislation. Additionally, each country has local self-regulating associations that monitor the activities of their member companies.
In Finland, compliance is monitored by Pharma Industry Finland (PIF) in respect of its member companies. For promoting prescription-only (Rx) medicines towards HCPs, the minimum requirement is a valid marketing authorisation (MA) for the product. The compulsory information is relatively extensive and must be readable without trouble in terms of font size, type and contrast. In Finland, nurses are generally not seen as HCPs and may therefore not be subject for Rx marketing. HCPs include persons whose work envisages the prescription or dispensing of medicines: physicians, dentists, veterinarians, senior pharmacists and pharmacists, as well as some nurses, opticians and dental hygienists who have a limited right to prescribe certain medicines.
In Sweden, oversight comes from Läkemedelsindustriföreningen (LIF) and the IGN system. Similarly to Finland, a valid MA is the only requirement for promotion of Rx medicines to HCPs. The compulsory information is typically shorter than in other countries. The text should always be easily legible. Marketing of prescription-only medicines may only be provided to HCPs that are allowed to prescribe and/or administer a medicinal product. Licensed nurses may have an authorization to prescribe certain very limited medicines but may also administer prescription medicines, and therefore it is allowed to include also licensed nurses in promotional information about such products.
In Denmark, the national adherence to national ethical code is overseen by Etisk Nævn for Lægemiddelindustrien (ENLI). A medicinal product can lawfully be marketed in Denmark when it has a valid MA and the price of the product must have been notified to the Danish Medicines Agency. The compulsory information is detailed and must be easily legible – a font size of less than 6 pt would not normally be approved. In Denmark, nurses are regarded as HCPs.
In Norway, promotional rules are overseen by Legemiddelindustrien (LMI). A valid MA and governmental approved price are required for promotion of Rx medicines. The scope of the compulsory information is typically between the texts of Sweden and Denmark in terms of length. It must have a clear placement with easily readable font. Similarly to Denmark, nurses are considered HCPs in Norway.
In Iceland, the national association for pharmaceutical industry is Frumtök. Similarly to Denmark, in addition to a valid MA, a price approved by the Medicines Agency and confirmation that publication of the price in the official price catalogue is awaiting are needed to promote an Rx medicine. The compulsory information must be clear and easily readable, so that the target group can easily comprehend the information. In Iceland, HCPs are those who are qualified to prescribe or distribute medicinal products, i.e. physicians, dentists, pharmacists, registered nurses and midwives, as well as veterinarians.
Abbreviated product information – mandatory in all promotional materials addressed to HCPs
A common feature in each country is the requirement to include abbreviated product information (also known as compulsory information, abbreviated PI, abbreviated SmPC, short SmPC) in all promotional materials targeting healthcare professionals. This is a shortened version of the Summary of Product Characteristics (SmPC) and ensures that essential information is always present alongside promotional claims. For an advertisement aimed at Nordic HCPs a compilation of the abbreviated PI from all the countries you aim the advertising at is needed.
How Medfiles supports your marketing material compliance – tailored review process
Medfiles supports pharmaceutical companies in reviewing compliant promotional materials across all Nordic and Baltic countries. We provide medical, ethical and editorial review for marketing materials of pharmaceutical products. In addition to the review tasks, a large part of our work involves preparing and updating abbreviated SmPCs, ensuring they follow each country’s specific format and requirements.
With extensive experience from 300+ marketing material reviews each year, we can help you ensure your campaigns are ready for launch – accurate, compliant and adapted to every market.
If your material needs to meet both your marketing goals and varying national requirements, we can provide suggestions and solutions for all target countries simultaneously. If you are planning to use the same marketing material in the Nordic countries, using a content management platform where all local reviewers work simultaneously helps streamline the process. This way you avoid multiple edit rounds and separate contacts for each country.
Our services are always tailored to your needs – whether you require ongoing support or help with a single project.
See also: Outsourcing local regulatory affairs: 4 examples of tailored support in the Nordics and Baltics
Author: Mikko Reinman
Head of Operations, Pharma Regulatory Affairs
Mikko Reinman has worked at Medfiles since 2009. Biochemist and food chemist by education, Mikko has extensive laboratory experience, having worked as an R&D chemist and analytical chemist in several companies. During his career, Mikko has been involved in various pursuits, including developing analytical platforms and targeting technologies, as well as quality assurance and IPR issues.
After switching to pharma regulatory, Mikko has gained more than 15 years of experience in product maintenance, first at a pharma company and then at Medfiles. Mikko’s first position in the pharma regulatory field involved working with product information texts and local regulatory responsibilities, and later, he proceeded to global regulatory manager tasks, including marketing authorisation maintenance and variation strategies. At Medfiles, Mikko has also worked with pharmacovigilance, compliance, project management and marketing. Since 2014, Mikko has worked as a regulatory affairs manager, and today, his title is Head of Operations, leading a team of highly skilled regulatory experts.
Author: Elina Krannila
Senior Regulatory Affairs Expert
Elina is a pharmacist and has been working at Medfiles since 2011. She is part of the Compliance Team, where she handles regulatory tasks related to marketing materials. The team’s daily work includes review (medical, editorial and ethical) of marketing materials, writing of abbreviated product information and consulting on marketing related matters such as events and co-operations. The team is well versed in the local legislation and ethical guidance and has country specific practical knowledge.
