Pharmaceutical marketing in Finland is strictly regulated under national legislation and industry self-monitoring. Marketing materials must be aligned with the approved Summary of Product Characteristics (SmPC), include mandatory information, target the correct audience and avoid misleading claims. The marketer is always accountable for compliance in their marketing actions.
Marketing materials are one of the most visible parts of pharmaceutical operations and one of the most common sources of compliance risk, particularly when local legislation or ethical guidance is open to interpretation. In this Q&A, Medfiles’ experts address some of the most common questions about the requirements for marketing materials and pharma companies’ practical implementation.
This post focuses specifically on marketing materials, compliance risks and regulatory requirements in Finland. See also our related posts on the Nordic and Baltic markets.
What is considered pharmaceutical marketing in Finland?
Pharmaceutical marketing refers to all activities and communications used by pharmaceutical companies to promote their medicines, including advertising to consumers or healthcare professionals (HCP), the activities of medical sales representatives, distribution of medical samples, and all marketing-related operations on the internet and social media.
Marketers are expected to be familiar with the norms in force in Finland. Outsourcing content or reviews does not transfer responsibility: the marketer (for example the Marketing Authorisation Holder) is always accountable for its marketing materials.
What counts as pharmaceutical marketing material?
Marketing materials can be divided into consumer-facing and HCP-facing materials. Consumer-facing materials, for example, include traditional advertising in print and on television; health awareness webpages and websites for non-prescription medicines; as well as digital formats, such as podcasts, social media content (for example carousel posts) and banner advertisements.
HCP-facing materials may include, for example, brochures, business presentations, and other materials related to prescription medicines, such as conference presentations, company invitation letters and exhibition stands.
Even materials that are intended to be informational or educational may in practice be considered marketing materials, depending on their content and context.
Can global marketing materials be used in Finland?
Global marketing materials can be adapted for local use. However, the requirements for the marketing materials vary between countries, and all materials must always comply with local regulations. For example, the required content of abbreviated product information (aPI) may differ across markets. It is essential that all information is fully aligned with the locally approved SmPC.
Who supervises pharmaceutical marketing in Finland?
Pharmaceutical marketing in Finland is supervised by the Finnish Medicines Agency Fimea under the Medicines Act and the Medicines Decree. The pharmaceutical industry complements statutory regulation through self-monitoring of pharmaceutical marketing. This self-monitoring framework is grounded in the Code of Ethics issued by Pharma Industry Finland (PIF).
What are the key rules for pharmaceutical marketing?
In Finland, only medicinal products with a valid marketing authorisation or registration may be marketed. Marketing must comply with the requirements for standard or reminder advertising. Marketing must:
- be appropriate, identifiable and transparent
- not encourage unnecessary use
- not target children
- clearly present the indication, required minimum information and safety information
- be consistent with the approved SmPC
- include only claims that are correct and verifiable.
Prescription-only medicines may be marketed only to persons entitled to prescribe or dispense them, while non-prescription medicines may be marketed to consumers, provided that the applicable content restrictions are taken into account.
What information must be included in marketing to consumers?
Only non-prescription medicines can be marketed to consumers. The minimum information in an advertisement for medicines targeted at consumers includes:
- medicine’s name and indication
- name of the pharmaceutical substance (if only one active ingredient)
- necessary information for the correct and safe use of the medicine as well as any special precautions for use, interactions and adverse effects significant for the medicine’s safety
- explicit advice to read the package leaflet or user instructions
- name of the marketing authorisation holder, importer or marketer
- for veterinary medicines, approved target species and maximum residue limits (MRL).
What information must be included in marketing to HCPs?
Marketing of prescription-only medicines is permitted only to persons entitled to prescribe or dispense them. Other healthcare professionals, such as nurses, may only receive guidance and training on the correct and safe use of the medicine. Non-prescription medicines can be marketed to all healthcare professionals.
Advertising of medicinal products directed at HCPs must include essential information about the medicinal product and its use:
- information that is in line with the latest approved SmPC and essential for the prescription of the medicine
- statutory dispensing conditions
- reimbursement terms and average therapy costs (whenever possible)
- retail prices of different package sizes (if available).
When the above information is compiled into a single text, it is referred to as abbreviated product information. More information on abbreviated SmPCs is available here: Pharma marketing compliance in the Nordics: key rules
What are the most common compliance issues in pharmaceutical advertising?
The following examples highlight the typical non‑compliant practices in pharmaceutical advertising:
- claims that go beyond the approved SmPC
- claims about the medicinal product are not supported by a valid reference
- abbreviated product information is not accordant with the latest approved SmPC
- non‑compliant comparison between products
- inappropriate, intimidating or misleading visual representations in advertising images showing disease‑related symptoms in people
- the material is aimed at HCPs, but the audience includes nurses. However, nurses are generally not classified as HCPs under Finnish regulations, with the exception of nurses who have limited prescribing rights for certain medicines
- using statements suggesting that medicine is safe or it has no adverse effects.
What should companies consider when marketing medicines on social media and internet?
Regardless of the format, whether a carousel post, a banner, a podcast or a webpage, the pharmaceutical company is fully responsible for the advertisement as a whole and for its compliance. This responsibility includes the functionalities and features of the publishing platform, such as sharing, liking and commenting.
The responsibility also extends to any discussions about medicinal products that the pharmaceutical company enables on its own social media channels. Consequently, the pharmaceutical company should exercise particular care and diligence when collaborating with influencers or content creators, as it remains responsible for all medicinal product‑related discussions that are generated or enabled through such collaborations. As is well known, especially on social media, the management and monitoring of such discussions can be highly challenging.
What are the rules for using pictures in marketing?
Not all types of pictures may be used in marketing; all visuals must comply with local regulations. Any pictures used in marketing materials must also be consistent with the information in the SmPC. The restrictions apply regardless of the type of the material used.
Pictures are not allowed to:
- be misleading or give an incorrect idea of the therapeutic value of the medicinal product
- exaggerate
- intimidate patients
- present the outcome of the medicine’s use in a misleading way
- be offensive or use tasteless expressions.
Using non-compliant pictures is not only against regulations but can also lead to reputational damage.
Pharmaceutical marketing in Finland is highly regulated, and even minor inconsistencies with the SmPC or local requirements may lead to non-compliance. Systematic review and local expertise are essential in ensuring compliant and effective marketing materials.
Medfiles offers dedicated local regulatory affairs services in Finland with our in-house experts. Our team combines in-depth regulatory knowledge with a strong understanding of country-specific requirements and language. We support pharma companies in medical, editorial and ethical reviews of marketing materials and help ensure compliance with local legislation and ethical codes, without compromising the marketing message. Our team reviews over 300 promotional materials annually.
See also: Outsourcing local regulatory affairs: 4 examples of tailored support in the Nordics and Baltics
Author: Mari Lindevall
Regulatory Affairs Expert
Mari joined Medfiles with a diverse background in pharmacy and the pharmaceutical industry. She holds a Master’s degree in Pharmacy from the University of Helsinki, with a major in Industrial Pharmacy, and has additional university studies and certifications in project management.
At Medfiles, she works in regulatory affairs with medicinal product information, marketing materials and packaging material artworks.
Her professional background includes experience in quality assurance, clinical research and both community and hospital pharmacy. Mari values the variety of her role and enjoys challenging client questions across the regulatory field, as they keep her continuously learning and motivated.
Author: Elisa Uimari
Regulatory Affairs Expert
Elisa Uimari has been working at Medfiles since 2024 and has developed a strong experience reviewing a diverse range of marketing materials. The variety of materials allows her to continuously develop her expertise.
Her daily work focuses on regulatory compliance tasks, including medical, editorial and ethical review of marketing materials as well as coordination of PI text updates and translations.
Elisa also has experience in compiling abbreviated SmPC texts, proofreading and regulatory review of packaging materials and delegated tasks of Responsible Pharmacist, such as product complaint handling.
She holds a Master’s degree in Pharmacy from the University of Helsinki. Before joining Medfiles, Elisa worked as a community pharmacist.
