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In Cybersecurity, Data and Tech

Hungary: Hungarian Cybersecurity requirements

by and 3 Mins Read

The Hungarian Government has published a new draft decree, which, once adopted, will establish new fines for failure to provide data, either within the deadline or at all, that is necessary for the registration of organizations under Act XXIII of 2023 on Cybersecurity Certification and Cybersecurity Supervision (“Cyber-certification Act”), which is the Hungarian transposition of the NIS2 Directive [Directive (EU) 2022/2555]. For numerous organizations, the above-mentioned deadline was 30 June 2024.

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In Product Regulation & Liability

Hungary: Pharmaceutical law developments

by and 4 Mins Read

Under the recently published Act XXIX of 2024 amending certain acts concerning the operation of the State, as of 1 January 2025, certain decisions on named patient reimbursement of medicinal products will be made by a newly created public benefit foundation in addition to the NEAK. Further, starting from 1 January 2026, the operator of the National eHealth Infrastructure (EESZT) may give access to the stored data for the purpose of AI development.

In Employment

Hungary: Employment supervisory inspections – experiences and risks

by and 3 Mins Read

The employment supervisory authority has published its annual report summarizing its findings from inspections carried out over 2023. The main objective of the inspections was to assess the extent to which employers comply with the basic rules on employment. We highlight the most important takeaways of the authority’s report and our expectations for the future.

In Product Regulation & Liability

Hungary: National Public Health and Pharmaceutical Center established

by 7 Mins Read

As of 1 August 2023, the National Institute of Pharmacy and Nutrition will be merged into the National Public Health Center. The resulting new authority will be called the National Public Health and Pharmaceutical Center (NNGYK).
The new authority will be headed by the Chief Medical Officer, and in terms of administrative hierarchy, the NNGYK will be under the supervision of the Minister of the Interior, acting in the capacity of Minister responsible for Health.

In Product Regulation & Liability

Hungary: Reforms aiming to remove hurdles to late market access of innovative pharmaceuticals

by 3 Mins Read

Reimbursing medicinal products is critical to ensure that treatments are widely available to patients. This is especially true for innovative products and is expected to become even more important with the EU Pharma reform package. Pricing and reimbursement (P&R) is an area regulated at Member State level, and on average the regulatory approach in Hungary has been on the stricter side for new medicinal products causing delay to market access. However recent legal reforms in Hungary on P&R aim to improve the situation and ensure earlier access for patients to innovative medicines.

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In ESG

European Union: Commission tables proposal for Green Claims Directive

by , and 6 Mins Read

On 22 March 2023, the European Commission tabled a proposal for a Directive on substantiation and communication of explicit environmental claims.
The proposal aims to harmonize the evaluation and monitoring of voluntary environmental claims – often referred to as “green claims” – towards EU consumers and control the proliferation of public and private environmental labels. Complementing the March 2022 proposal for a Directive on empowering consumers for the green transition as a lex specialis by providing more specific requirements on the substantiation, communication and verification of green claims, it contributes to the fight against “greenwashing”.

In Product Regulation & Liability

Hungary: Regulatory authority weighs in on Medical Science Liaison position

by and 3 Mins Read

Pharma companies often employ Medical Science Liaisons (MSLs) in order to provide healthcare professionals (HCPs) with high-quality professional and scientific information that lacks promotional content thereby distinguishing it from the information provided by medical sales representatives.
In a recently published decision, the National Institute of Pharmacy and Nutrition (NIPN) stated that it does not support distinction between professional and promotional communication. This position leaves pharma companies with two options: either to register MSLs with the NIPN as a medical sales representative, or to try to severely restrict the information an MSL may share with HCPs.

In Product Regulation & Liability

Hungary: Lessons learned from the most recent NIPN decisions

by and 6 Mins Read

In the last month, the Hungarian National Institute of Pharmacy and Nutrition (NIPN) published five new decisions on its website relative to the promotional practices of companies under investigation. The NIPN imposed fines for infringements within the range of HUF 3 million (approx. EUR 7,700) to HUF 31 million (approx. EUR 79,500).

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