Hungary

Hungary

This subtopic provides a range of guidance on the law in Hungary.

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Latest EU Law News

EFPIA proposes action plan to address medicine shortages in Europe

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has put forward a detailed proposal to tackle medicine shortages across Europe. The plan calls for a harmonised EU shortage prevention and mitigation system, including a standardised definition of shortages and an interoperable IT monitoring system. The EFPIA advocates for a risk-based approach focused on critical medicines, improved transparency of patient demand, and enhanced supply security through EU-owned strategic reserves. The proposal also recommends regulatory flexibilities to facilitate stock reallocation, measures to strengthen the EU manufacturing base, and efforts to boost global supply chain resilience through international partnerships. These recommendations aim to ensure a more robust and responsive pharmaceutical supply chain whilst maintaining a focus on innovation and patient access to medicines.

EIOPA issues Annual Report on Insurance Distribution Directive Sanctions for 2023

The European Insurance and Occupational Pensions Authority (EIOPA) has issued its fifth annual report on administrative sanctions and measures imposed by National Competent Authorities (NCAs) under the Insurance Distribution Directive (IDD) for 2023. The report highlights an increase in sanctions related to product oversight, governance, and general conduct of business requirements across 20 Member States.

EMA publishes updated ICH E6(R3) guideline for good clinical practice

The European Medicines Agency (EMA) has published the updated ICH E6(R3) guideline for good clinical practice, which will take effect on 23 July 2025. This updated guideline introduces a new structure comprising overarching principles and objectives document, Annex 1 for interventional trials, and Annex 2 for non-traditional interventional trials. ICH E6(R3) incorporates innovative provisions designed to apply across various trial types and settings, promoting a risk-based, proportionate approach to conducting clinical trials. Annex 1 is intended to provide guidance on applying the overarching principles to clinical trials. The overarching principles and Annex 1 have been adopted by ICH and CHMP and will take effect in July 2025. Annex 2, which addresses pragmatic and decentralised clinical trials, as well as those incorporating real-world data, is expected to be finalised later in 2025. The current ICH E6(R2) guideline in effect until 22 July 2025, enabling stakeholders to transition to the new standards.

EU Law weekly highlights—30 January 2025

This week's edition of EU Law weekly highlights includes analysis on data protection concerns of the Chinese generative AI model DeepSeek and the European Insurance and Occupational Pensions Authority and European Central Bank’s proposals to close insurance protection gap. In addition, this week the European Commission introduced the competitiveness compass, opened consultations on four draft implementing acts for the Net Zero Industry Act and published the Platform on Sustainable Finance report, the Dutch Supervisory Authority imposed a €4.75m fine on Netflix for EU General Data Protection Regulation breaches and the European Medicines Agency published guidelines on the use of Specific Adverse Reaction Follow-up Questionnaires.