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[:uk]Review of Ukrainian legislation for 23/10/2024[:][:uk] Digest of Ukrainian Legislation Accounting Prices for Banking Metals The National Bank of Ukraine […]

[:uk]On Amendments to the Code of Ukraine on Bankruptcy Procedures and Certain Other Legislative Acts of Ukraine Regarding the Implementation of Directive (EU) 2019/1023 of the European Parliament and of the Council and the Introduction of Preventive Restructuring Procedures[:][:uk] Analysis of the Law on Amendments to the Code of Ukraine on Bankruptcy Procedures Functional Changes in the Code of Ukraine on Bankruptcy Procedures The new Law of Ukraine on amendments to the Code of Ukraine on bankruptcy procedures and certain other legislative acts aims to implement Directive (EU) 2019/1023 of the European Parliament and of the Council. The main focus of the amendments is the introduction of preventive restructuring procedures. Implementation of Preventive Restructuring The law introduces mechanisms for preventive restructuring aimed at the early resolution of financial difficulties faced by enterprises. This procedure allows debtors and creditors to collaboratively develop a restructuring plan to avoid bankruptcy. Changes to Bankruptcy Procedures The Code on bankruptcy procedures is supplemented with provisions regulating new stages for filing applications for restructuring, requirements for restructuring plans, and mechanisms for their approval. Amendments have been made regarding the rights and obligations of the parties during the restructuring process. Criteria for Preventive Restructuring Clear criteria have been established under which an enterprise may initiate the preventive restructuring process. These include financial incapacity, unstable financial condition, and other indicators that suggest a potential need for restructuring. Procedures and Mechanisms The law defines detailed procedures for submitting and reviewing applications for restructuring, including timelines, necessary documents, and the responsibilities of the involved parties. Mechanisms for monitoring the implementation of approved restructuring plans are also established. Rights and Obligations of the Parties The rights of the debtor in submitting an application for restructuring and the obligations of creditors regarding participation in the process have been defined. The law also regulates the informational obligations of the parties and mechanisms for resolving disputes that may arise during the procedure. Implementation of EU Directive 2019/1023 The law ensures compliance of national legislation with the provisions of EU Directive 2019/1023 aimed at creating effective frameworks for the restructuring of debtors. This includes the harmonization of procedures, timelines, and mechanisms with European standards. Other Changes to Legislation In addition to changes to the Code on bankruptcy procedures, the law amends other regulatory acts related to corporate law, protection of creditors’ rights, and ensuring […]

[:uk]Review of the EU legislation for 22/10/2024[:][:uk] Overview of Recent EU Regulations Commission Implementing Regulation (EU) 2024/2741 This regulation […]

[:uk]Commission Implementing Regulation (EU) 2024/2699 of 18 October 2024 laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices[:][:uk] Commission Implementing Regulation (EU) 2024/2699 Overview Commission Implementing Regulation (EU) 2024/2699 Overview Article 1: Subject Matter This Regulation establishes detailed procedural rules for cooperation between the Member State Coordination Group on Health Technology Assessment (the Coordination Group), the Commission acting as the HTA secretariat, and the European Medicines Agency (EMA). The cooperation encompasses: Planning and forecasting of joint clinical assessments and joint scientific consultations. Identification of patients, clinical experts, and other relevant experts for participation. Exchange of information on horizontal scientific and technical matters related to joint activities. Security measures for sharing and protecting confidential information exchanged between the EMA and the HTA secretariat, and subsequently with the Coordination Group and its subgroups. Article 2: Information Exchange Related to Planning and Forecast By April 30 each year, the EMA must provide the HTA secretariat with: Medicinal Products: Upcoming submissions of initial marketing authorization applications, including details such as the active substance name, developer name, therapeutic indication summary, eligibility basis for centralised procedure, priority scheme eligibility, and expected submission dates covering the current and following year. Information on variations to existing marketing authorizations for new therapeutic indications planned by holders. Estimated number of advice procedures under Article 57(1)(n) of Regulation (EC) No 726/2004. Medical Devices and In Vitro Diagnostic Medical Devices: Number of ongoing and finalized advice procedures initiated by manufacturers, including device type, intended purpose, medical indications, contraindications, target populations, and development phase. Estimated number of future advice requests from manufacturers. Additionally, the EMA must provide updates relevant to the preparation of reports on emerging health technologies. Article 3: Information Exchange Related to Selection of Medical Devices for Joint Clinical Assessment The EMA is required to provide the HTA secretariat with information on: All medical devices for which expert panels under Regulation (EU) 2017/745 have provided or intend to provide scientific opinions, including device name and type, manufacturer, notified body, expert panel decisions, and available scientific opinions. All in vitro diagnostic medical devices under similar expert panel evaluations, including device name and type, manufacturer, notified body, and available expert panel views. This information must be submitted no later than 15 days after the end of each quarter, starting from January 1, 2024. Article 4: Information Exchange with the Coordination Group and Its Subgroups Upon receiving information from the EMA: The HTA secretariat must provide the relevant information to the EHT Subgroup or the Coordination Group for analysis and preparation of reports on emerging health technologies and the annual work programme. The EHT Subgroup may consult the EMA through the HTA secretariat while preparing these reports. Information related to the selection of medical devices for joint assessments must be provided to the Coordination Group or its relevant subgroups for recommendation purposes. Article 5: Information Exchange on Identification of Individual Experts The EMA must provide the HTA secretariat with information on potential experts, including names, contact details, and areas of expertise, upon request. The Regulation ensures: Recording whether an expert is engaged in evaluations related to the same medicinal product or device within different procedures. Protection of personal data in compliance with Regulation (EU) 2018/1725, including measures like pseudonymisation and access controls. Retention of personal data for up to three years for experts not selected for joint work. Article 6: Information Exchange on Horizontal Scientific and Technical Matters The Coordination Group and its subgroups are tasked with exchanging scientific and technical information with the EMA on issues that affect joint clinical assessments and consultations, excluding the assessment of specific health technologies. The coordination may involve the HTA stakeholder network to enhance decision-making and knowledge sharing. Article 7: Secure Exchange of Information Information between the HTA secretariat and the EMA must be exchanged through the HTA IT platform, a secure system designed for this purpose. The exchange is governed by technical specifications that ensure effective technical and security measures for interfacing, access, and data processing. Article 8: Protection of Confidential Information Information received from the EMA must be used exclusively for joint assessments and consultations. The EMA must indicate the protection level of shared information, and the HTA secretariat must maintain at least an equivalent level of protection when sharing with the Coordination Group and its subgroups. Members must implement technical and organizational measures to safeguard confidentiality, limiting access to authorized individuals and reporting any breaches immediately. Article 9: Failure to Respect Professional Secrecy If a representative or individual expert breaches professional secrecy: The Commission will notify the individual and request clarification within 14 days. Failure to provide clarification may result in exclusion from joint work until the issue is resolved. If intentional or grossly negligent, exclusion can last up to two years. The HTA secretariat is responsible for informing relevant parties and enforcing the Commission’s decisions. Article 10: Entry into Force This Regulation enters into force 20 days after its publication in the Official Journal of the European Union and applies from January 12, 2025. It is binding and directly […]

[:uk]Review of Ukrainian legislation for 22/10/2024[:][:uk] Digest of Legislative Acts Digest of Legislative Acts Resolutions of the National Bank of […]