Hungarian pharmaceutical authority imposes fines for non-compliant promotional activity

On 17 March 2026, the Hungarian National Public Health and Pharmaceutical Authority (NNGYK) announced they have imposed a fine of EUR 38,000 on the Hungarian affiliate of a US-based biotechnology company, a fine of EUR 51,000 on the Hungarian affiliate of a US-based consumer goods company and a fine of 46,000 on a Hungarian pharmaceutical company.

The NNGYK conducted investigations into pharmaceutical promotional activity and imposed fines for activities by unregistered or unauthorized medical sales representatives, failure to comply with reporting obligations for professional events, providing non-compliant in-kind benefits to healthcare professionals (HCPs) and using claims in promotional materials that were not well-established.

1. Background

The NNGYK released three decisions following investigations into major pharmaceutical companies, reviewing their promotional activities with significant scrutiny. The authority has been active in the recent past, imposing fines for non-compliant promotional practices in the pharmaceutical sector. Below are the key findings and implications for other market participants.

2. Decision against the Hungarian affiliate of a US-based biotechnology company

The authority established the following infringements and imposed a fine of approximately EUR 38,000:

• Promotional activity by individuals not registered as authorised medical sales representatives: At two professional events supported by the company, presentations were delivered by physicians who were not employed by the company and were not registered as authorized medical sales representatives, even though the content of their presentations clearly met the statutory definition of “promotion”. The presentations included references to the specific medicinal product belonging to the company’s portfolio, its summary of product characteristics (SmPC) and information taken from the SmPC of the product concerned. As the physicians were actively engaged in healthcare service provision at the time, their involvement breached conflict‑of‑interest rules.
• Unlawful benefits provided to HCPs: at five professional events, the company operated promotional booths where HCPs could receive coffee and mineral water. Under the Medicines Thrift Act, any gift or benefit offered by a company engaged in promotional activity to an HCP is strictly prohibited unless it is of negligible value and directly connected to the recipient’s healthcare activity (rule of providing gifts). This rule is not limited to offering gifts or benefits in kind during promotional activities but, according to the legislator’s intent, applies more broadly to any situation within the company’s commercial practice. Consequently, whenever a company, within its commercial practice, provides such a benefit to an HCP, the rule of providing gifts applies, regardless of the relationship between the parties or whether a specific product is being promoted. The authority considers that promotional booths at professional congresses aim to facilitate active interaction between promoter companies and HCPs. Therefore, the rule of providing gifts also applies when hospitality (e.g. coffee, soft drinks, snacks) is offered at such booths to HCPs. As business hospitality constitutes a benefit unrelated to the HCPs’ healthcare activity, it is considered a prohibited benefit, irrespective of its value.

3. Decision against the Hungarian affiliate of a US-based consumer goods company

The authority established the following infringements and imposed a fine of approximately EUR 51,000 for them:

• Promotional activity by individuals not registered as medical sales representatives: the NNGYK found that in 2024, individuals carried out promotional activities who were not registered as persons employed by the company conducting promotional activities under an employment or other work‑related legal relationship and therefore did not hold a promoter’s ID card. Six unregistered individuals conducted a total of 3,725 promotional visits, while another employee continued promotional work 36 times after their registration had already been terminated. Additionally, during several months of 2024, the company conducted 3,393 further promotional activities without having any registered representatives.
• Non-compliant reporting practices: the authority determined that the company failed to properly comply with mandatory reporting obligations for professional events supported by the company. The company also supported various third‑party conferences and online educational activities in the healthcare product category (PHC), relating to medicinal products, without fulfilling its duty to report these events. The authority classified professional events involving healthcare and medicinal/medical device supply professionals as subject to the same reporting requirements. Therefore, regardless of the event’s format (including online), the reporting obligations apply to any company conducting promotional activities. The authority also considers that fees made as consideration (e.g. purchasing services such as booth rental), even if not part of a sponsorship package, shall not be considered as sponsorship but fall under the notion of ‘activities supported by the promoter company’ and thus remain subject to reporting.

4. Decision against the Hungarian pharmaceutical company

The authority established the following infringements and imposed a fine of approximately EUR 46,000 for them:

• Promotional activity: the authority determined that the company conducted promotional activities at professional events supported by the company through individuals who were not registered as authorised medical sales representatives at the time of the events. In some instances, the NNGYK concluded that presentations of HCPs, due to their appearance, content and the message delivered, functioned as product promotion. The presenters were not registered as authorised medical sales representatives and were in conflicting healthcare employment relationships with a healthcare provider, thus the company also violated the conflict-of-interest rule.
• Problematic promotional materials (brochures): The NNGYK also found significant issues in the company’s promotional materials:
  • several brochures contained inaccurate, incomplete or misleading scientific claims, presented benefits without appropriate warnings or made statements inconsistent with approved product documentation or scientific literature.
  • some materials implied unproven safety advantages, suggested effects unsupported by clinical evidence or cited scientific sources inaccurately. The authority concluded that these materials failed to meet legal requirements for accuracy, objectivity and alignment with approved product information. By distributing promotional materials containing inaccurate statements and claims that were not consistent with the approved SmPC and/or the scientific literature, the company violated several legal requirements.
• Reporting obligations: in addition, the company repeatedly failed to submit timely notifications for professional events it organised or supported. Nine events were reported late, despite the legal requirement to notify the authority at least 15 days before such meetings involving HCPs.

5. Key considerations for market participants

This decision reflects the NNGYK’s heightened scrutiny of pharmaceutical promotional activities.

Companies promoting medicinal products or medical aids in Hungary should ensure that:

• the personnel carrying out promotional activities for or on behalf of them are registered as medical sales representatives;
• the conflict-of-interest rule is not violated by carrying out promotional activities through a person in a legal relationship with a healthcare provider;
• they comply with their reporting obligations regarding professional events organised and sponsored by them, regardless of the format of the event (online); and
• the rules on providing gifts are complied with during the company’s commercial practice, including at promotional booths at professional congresses.

For legal advice on advertising compliance and competition law matters in the Hungarian pharmaceutical and health products sector, please contact our Life Sciences & Healthcare team.