Expert comment: Promotional compliance – major updates in 2025 for the Nordic region

17 December 2025

With 2025 coming to a close, we have seen several important updates to Nordic promotional compliance codes over the past year. This overview highlights the key developments affecting promotional activities in the Nordics and outlines their implications for pharmaceutical and healthcare stakeholders.

Sweden – LER update

On 29 September 2025, LIF’s ethical rules for the pharmaceutical industry in Sweden (LER) was updated – a welcome update, as this is the first update since July 2022.

Mandatory product information (miniSmPC) no longer required for patient brochures

The requirement to meet miniSmPC requirements (LER Art. 117) for prescription pharmaceuticals has been lifted for patient brochures. The reasoning behind this change is that LER Art. 117 primarily regards promotional materials, and the main objective of these patient information brochures is to aid the patient in their treatment: promotional messages are not allowed, in line with broad prohibition of promoting prescription pharmaceuticals towards the general public. As such, the updated interpretation of the code is that it is deemed obsolete to include miniSmPC’s for patient information brochures.

This change aligns the Swedish code with its Nordic counterparts, and it eases the workload for pharmaceutical companies as a patient-directed miniSmPC variant is no longer needed for Swedish materials. A well-designed brochure together with the prescribing healthcare professional’s guidance is likely to be sufficient for the patient’s needs.

This change should be implemented for new printed materials, or alternatively, all materials should be updated by 29 September 2026.

Extended reporting deadline to LIF’s cooperation database

The deadline for reporting cooperation with medical/scientific organizations or development projects was previously set to the start date of the cooperation: As of 29 September 2025, the new deadline is within 3 months of the cooperation’s start date.

LIF stresses that the main importance of the reporting rules is to provide transparency of the LIF member’s activities and therefore, to provide flexibility and ease the reporting process for member companies, a longer deadline can be allowed.

To give context of the extent of the reporting difficulties: The IGN/NBL database shows that in 2025, out of a total of 45 IGN cases, 16 were fines related to cooperation database reporting deficiencies. 7 were late by only a few (1-12) days, while the remaining 9 cases were either late by several months, self-reported cases, or the cooperation report was missing altogether.

The new, extended deadline will make it administratively easier for member companies to fulfil their reporting requirements as it can now be done in batches, while maintaining a high level of transparency towards the general public.

Norway – LMI Bransjeregler, 2025 update

The Norwegian code of ethics, LMI Bransjeregler, was updated on 01 May 2025.

Mandatory product information/miniSmPC at exhibitions

In exhibition spaces at for example scientific congresses, it is no longer possible to provide the miniSmPC information at the booth and use referrals for booth material (roll-ups, screens, booth walls etc). The miniSmPC information must be conveyed visually in the same manner as the actual advertisement – effectively, it must be presented directly with the advertisement material.

This means that all advertisement materials for exhibition booths where the Norwegian rules are applicable, must ensure that enough space is reserved for including the miniSmPC information on the advertisement(s).

Mandatory product information/miniSmPC language requirements

In LMI Bransjeregler 2025, it is now explicitly stated that the miniSmPC should be written in Norwegian. This aligns the code to that of the Norwegian health authority DMP’s guidance, which since November 2024 state that the mandatory information should be in Norwegian.

This updated requirement has implications for materials presented in international contexts such as international congresses held in Norway, and also introduces further challenges for enabling marketing campaigns aimed at a Nordic audience to ensure Norwegian compliance, as the Norwegian text cannot be written in English and be merged with other countries’ mandatory information.

Denmark – 2025 ENLI newsletter highlights

In conjunction with ENLI’s March 2025 newsletter, ENLI’s promotion code was updated. We have selected a couple of highlights below.

Deadline updated for reporting of sponsorships to ENLI

Previously, sponsorships had to be reported within 10 days of signed agreement. As of 01 April 2025, the deadline has been updated to 10 days prior to the opening of the event. In most cases, this should result in a less restrictive deadline for companies. 

Light meals now allowed for shorter professional meetings

A minimum of two hours professional content is no longer a prerequisite for providing a meal in meetings: Effective 01 April 2025, the Promotion Code has been amended to allow for a ‘light’ meal allowance of DKK 100 for shorter professional meetings (up to two hours – e.g. pharmaceutical sales reps visits).

In conclusion

Over the past year, we have seen both eased restrictions (such as in Sweden and Denmark), as well as stricter rules, as is the case in Norway. The differing trends across these Nordic countries underscore the importance of staying on top of the promotional code updates in order to ensure promotional compliance.

Olle Fahleson

MSc, Expert Regulatory Affairs & CMC

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Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.