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[: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 Commission Implementing Regulation (EU) 2024/2699 Article 1: Subject Matter Establishes detailed procedural rules for cooperation and information exchange between the Member State Coordination Group on Health Technology Assessment (Coordination Group), the HTA secretariat, and the European Medicines Agency (EMA) regarding joint clinical assessments and joint scientific consultations. The cooperation covers: Planning and forecasting of joint clinical assessments and consultations. Identification of patients, clinical experts, and other relevant experts. Horizontal scientific and technical matters. Security and protection of shared confidential information. Article 2: Information Exchange for Planning and Forecasting Mandates the EMA to provide the HTA secretariat by April 30 each year with: Details on upcoming submissions of initial marketing authorisation applications for medicinal products, including aspects like non-proprietary names, developer names, therapeutic indications, eligibility criteria, PRIME scheme eligibility, and expected submission dates. Information on medical devices likely to undergo joint clinical assessments, including device type, intended purpose, contraindications, target populations, and development phases. Additionally, the EMA must supply updates relevant for reports on emerging health technologies. Article 3: Selection of Medical Devices for Joint Clinical Assessment Requires the EMA to provide the HTA secretariat with information on medical and in vitro diagnostic devices undergoing scientific opinion procedures. This includes device names, types, manufacturers, notified bodies, and expert panel decisions or opinions. Reports must be submitted quarterly by the 15th day after each quarter’s end, starting from January 1, 2024. Article 4: Information Exchange with Coordination Group and Subgroups Upon receiving information from the EMA, the HTA secretariat must distribute it to the EHT Subgroup or Coordination Group as appropriate for the preparation of annual work programmes and reports on emerging health technologies. The EHT Subgroup may also consult the EMA when preparing these reports. Article 5: Identification of Individual Experts Provides that the EMA shall supply the HTA secretariat with information on potential experts, including names, contact details, and areas of expertise, upon request. Meeting minutes and assessment reports must note any expert’s engagement in related evaluations. Personal data processing is governed under Regulation (EU) 2018/1725, with the Commission acting as the data controller. Data retention for non-selected experts is capped at three years. Article 6: Exchange of Horizontal Scientific and Technical Information Ensures that the Coordination Group and its subgroups exchange information with the EMA on scientific and technical issues related to joint assessments and consultations. These exchanges should be facilitated by the HTA secretariat and exclude individual health technology assessments. The Coordination Group may involve the HTA stakeholder network in these exchanges. Article 7: Secure Information Exchange Mandates that the HTA secretariat and the EMA use the HTA IT platform, a secure information exchange system, for all joint clinical assessments and scientific consultations. The platform must adhere to strict technical and security specifications to ensure data protection and interoperability. Article 8: Protection of Confidential Information Specifies that information from the EMA is to be used solely for joint assessments and consultations. The EMA must denote the level of protection for shared information, and the HTA secretariat must assign at least equivalent protection levels before sharing with the Coordination Group or its subgroups. Members must implement technical and organizational measures to maintain confidentiality and report any breaches immediately. Article 9: Failure to Respect Professional Secrecy Obligations Outlines procedures if a Coordination Group member or expert breaches professional secrecy, including notifications, requests for clarification, potential exclusion from joint work for up to two years, and enforcement of measures by the HTA secretariat. Article 10: Entry into Force States that the Regulation comes into force twenty 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 21/10/2024[:][:uk]Digest of Legislative Acts Resolution of the Cabinet of Ministers of Ukraine on the Reorganization of […]

[:uk]Commission Implementing Regulation (EU) 2024/2686 of 17 October 2024 initiating an investigation concerning possible circumvention of the anti-dumping measures imposed by Implementing Regulation (EU) 2022/558 on imports of certain graphite electrode systems originating in the People’s Republic of China by imports of artificial graphite in blocks or cylinders originating in the People’s Republic of China and making such imports subject to registration[:][:uk] Commission Implementing Regulation (EU) 2024/2686 – Provisions Summary Commission Implementing Regulation (EU) 2024/2686 Date of Adoption: 17 October 2024 Subject: Investigation on Possible Circumvention of Anti-Dumping Measures on Graphite Electrode Systems from China Article 1: Initiation of Investigation An investigation is initiated under Article 13(3) of Regulation (EU) 2016/1036 to determine if imports of artificial graphite in blocks or cylinders from China are circumventing existing anti-dumping measures imposed by Implementing Regulation (EU) 2022/558. Article 2: Registration of Imports Customs authorities of Member States must register the imports identified in Article 1. Registration will expire 9 months after the Regulation enters into force. Article 3: Time-Limits for Interested Parties Interested parties must contact the Commission within 15 days from the Regulation’s entry into force. Submissions, including questionnaires and exemption requests, must be made within 37 days from publication in the Official Journal. Requests to be heard by the Commission must also be submitted within the same 37-day period, with specific provisions for initial stages. Article 4: Entry into Force The Regulation becomes effective the day after its publication in the Official Journal of the European Union and is directly applicable across all Member States. Section A: Request The European Commission received a request on 4 September 2024 from the European Carbon and Graphite Association to investigate possible circumvention of anti-dumping measures on certain graphite electrodes from China. Section B: Product Product Concerned: Graphite electrodes used in electric furnaces with specific density and resistivity, classified under CN code ex 8545 11 00. Product Under Investigation: Artificial graphite in blocks or cylinders with specified density and resistivity, classified under CN codes ex 3801 10 00 and ex 3801 90 00. Section C: Existing Measures The existing anti-dumping measures are those imposed by Implementing Regulation (EU) 2022/558. Section D: Grounds for Investigation The request provides sufficient evidence that existing measures are being circumvented by the import of the product under investigation. There has been a shift in trade patterns, with exports of the targeted product being replaced by the product under investigation due to assembly/completion operations in the Union. These practices undermine the remedial effects of the existing measures both in quantity and pricing, with evidence of injurious pricing and increased import volumes. Prices of the assembled/completed products in the Union are dumped compared to the normal value of the product concerned. The investigation may cover additional circumvention practices identified during its course. Section E: Procedure The Commission has determined that there is sufficient evidence to start the investigation and subject the imports to registration. Interested parties must contact the Commission by the deadline set in Article 3(2). The authorities of China have been notified about the initiation of the investigation. Subsection (a): Instructions for Submissions Information submitted must be free from third-party copyrights unless permission is obtained. All submissions requesting confidential treatment must be labeled ‘Sensitive’ and include non-confidential summaries. Parties must use TRON.tdi for submissions and provide accurate contact information for communication. Subsection (b): Information Collection and Hearings All interested parties are invited to submit their views and evidence within the deadline. The Commission may hold hearings upon written requests from interested parties. Subsection (c): Requests for Exemptions Importers not engaged in circumvention practices can apply for exemptions within the specified timeframe. Questionnaires and exemption forms are available for interested parties to submit their claims. Section F: Registration Imports of the product under investigation must be registered to enable the imposition of anti-dumping duties if circumvention is confirmed. Section G: Time-Limits Sets specific deadlines for interested parties to participate in the investigation process. Emphasizes the importance of adhering to time-limits for procedural rights. Section H: Non-Cooperation If parties do not provide necessary information, the Commission may proceed based on available facts. Provision of false or misleading information will result in such information being disregarded. Partial cooperation may lead to less favorable outcomes for those parties. Section I: Schedule of the Investigation The investigation must be concluded within 9 months from the Regulation’s entry into force. Section J: Processing of Personal Data Personal data collected will be handled according to Regulation (EU) 2018/1725. A data protection notice is available on DG Trade’s website. Section K: Hearing Officer Interested parties can request the intervention of a Hearing Officer for trade proceedings. The Hearing Officer manages requests related to file access, document confidentiality, time limits, and defense rights. Procedures for hearings and mediation are outlined, including requirements for timely and well-reasoned requests. Conclusion All provisions aim to ensure a comprehensive investigation into the potential circumvention of existing anti-dumping measures on specific graphite products imported from China. The Regulation outlines detailed procedures, rights, and obligations for all involved parties to facil […]

[:uk]Review of Ukrainian legislation for 19/10/2024[:][:uk] Digest of Legislative Acts Digest of Legislative Acts 1. Official Exchange Rate of the Hryvnia […]

[:uk]On Amendments to the Procedure for the Use of Funds Provided for in the State Budget to Ensure the Enforcement of Court Decisions[:][:uk] Analysis of the […]