Lebenswissenschaften - Regelung

Aktuelle eAlerts

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  02/10/2024

  Belgium

  First annual report on Belgian foreign direct investment screening

  On 1 June 2022, following the adoption of Regulation (EU) 2019/452 of 19 March 2019 establishing a framework for screening foreign direct investments in the EU, the various Belgian competent governments concluded a draft cooperation agreement, ratified by all competent Belgian parliaments, which aimed to introduce a foreign direct investment (“FDI”) screening mechanism in Belgium.The FDI control mechanism, which entered into force on 1 July 2023, provides for a mechanism of mandatory ex ante notification to the Interfederal Screening Committee (“ISC”) for investment projects...

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  02/10/2024

  Ungarn

  Hungary begins implementation of EU AI Act with passage of Resolution

  The Hungarian government has issued Resolution 1301/2024. (IX. 30.), which establishes the foundation for creating the body responsible for implementing the tasks required by the EU AI Act. In issuing this resolution, Hungary has begun preparations for enforcing the regulation, which means that companies should now prepare for compliance by reviewing the AI systems they use, assessing these systems' alignment with the EU AI Act's requirements, and preparing the necessary risk management documentation to ensure transparency, accountability, and safety.Hungary’s new enforcement body will:Operate...

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  23/09/2024

  Polen

  Polish Constitutional Court's position on restrictions on the pharmacy market - ‘Pharmacy for the Pharmacist 2.0’ law amendment unconstitutional

  GB PL

  In a judgment of 18 September 2024 (K 15/23), the Polish Constitutional Court found that the much-discussed amendment to the Pharmaceutical Law, widely known as Apteka dla Aptekarza 2.0 (Ada 2.0) or Pharmacy for the Pharmacist 2.0, contravenes the Polish Constitution in the way it was introduced.Ada 2.0 restricts the ability of entities or individuals who are not licensed pharmacists from taking control of pharmacies. Specifically, Ada 2.0 provides for the following:It prevents the acquisition of control, within the meaning of competition and consumer protection legislation, of an entity operating...

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  19/09/2024

  Ukraine

  New Ukrainian law regulates off-label use of medicines

  On 21 August 2024, the Ukrainian parliament introduced new legislation that formalises the off-label use of registered medicinal products. This regulation establishes clear procedures for healthcare professionals (HCPs) to prescribe medicines for non-authorised indications, age groups, dosages, or methods of administration, which are commonly known as off-label use. The goal is to ensure patient safety, transparency, and accountability in off-label prescriptions by requiring informed consent, medical advisory board approval, and thorough documentation.The new mechanisms complement the existing...

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  17/09/2024

  Ukraine

  Ukraine strengthens National Essential Medicines List framework

  On 21 August 2024, the Ukrainian parliament passed amendments to the legislation governing the National Essential Medicines List (NEML), which fills significant gaps in its regulation and clarifies the role and impact of the NEML on market access, pricing, reimbursement, and the public procurement of medicines in Ukraine.In addition, these amendments provide clearer criteria for listing medicines and introduce important new processes, such as an appeal pathway that will improve transparency and decision-making related to the NEML.Key Amendments to the LegislationThe following is a summary of the...

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  10/09/2024

  Ukraine

  Ukraine adopts regulation on collection and use of human cells and biospecimens for R&D

  On 30 August 2024, Ukraine introduced its first comprehensive regulation governing the collection, storage, and use of human biospecimens for research and development purposes. The regulation, approved under Cabinet of Ministers’ Resolution No. 999, outlines the legal and ethical framework for biobanking activities involving biomedical research, while safeguarding donor rights and data privacy. The regulation is a significant development in supporting Ukraine’s advancement in health sciences and biotechnology.Key Provisions The key provisions of the regulation include the following:Scope:The...

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