Test

[:uk]On the approval of the Procedure for the issuance of international certificates and other documents required by the legislation of the destination country for shipments of food products.[:][:uk] Analysis of Order No. 2252 dated 26.07.2024 Analysis of Order No. 2252 dated 26.07.2024 of the Ministry of Agrarian Policy and Food of Ukraine General Provisions This order defines the procedure for issuing international certificates and other documents required by the legislation of the destination country for shipments of food products. It is based on the regulatory acts of Ukraine, including the Law on the Basic Principles and Requirements for Food Safety and Quality and the Association Agreement between Ukraine and the European Union. 1. Issuance Procedure The order establishes a clear procedure for obtaining the necessary documents, including requirements for their completion and submission. Certificates must be issued in both paper and electronic forms, in compliance with international standards and Ukrainian legislation regarding electronic documents. 2. Types of International Certificates International certificate for shipments of food products of non-animal origin; International certificate for shipments of food products of animal origin or composite products; Pre-export international certificate for shipments of food products. 3. Issuance Requirements Shipments exported beyond Ukraine must be accompanied by original international certificates if required by the destination country. Certificates can be issued in paper or electronic form, with the electronic form complying with the recommendations of international organizations and EU legislation. 4. Authorized Persons International certificates are issued by state inspectors, state veterinary inspectors, or other authorized persons. To obtain authorization, individuals must undergo training and avoid conflicts of interest. Authorizations are formalized by an order of the territorial body of the State Consumer Service and a record of authorized persons is maintained. 5. Application Submission The issuance of certificates is carried out upon the application of the market operator, which may be submitted in person, by mail, or electronically through the Unified State Web Portal of Electronic Services (Diia Portal). The application must contain all necessary information and documents, such as copies of foreign economic contracts and documents confirming the compliance of the shipment with the requirements of the destination country. 6. Issuance Timeframes International certificates are issued within one working day from the moment the application is submitted, except in cases where laboratory research is required. In such cases, the timeframe may be extended until the results of the research are provided. 7. Refusal of Issuance Refusal to issue a certificate may be justified by the absence of necessary information, false data, inability to inspect the shipment, or identification of non-compliance with the requirements. The decision to refuse must indicate the grounds and circumstances. Issuance of International Certificates For Shipments of Food Products of Non-Animal, Animal Origin, and Composite Products The application must contain detailed information about the manufacturer, sender, destination country, description of the shipment, and special requirements of the destination country. The application must include copies of foreign economic contracts, compliance documents, transport documents, and other necessary supporting documents. Pre-export Certificates These certificates are issued in cases where the destination country or final transport vehicle is not determined at the time of shipment. They contain all necessary information, except for the specification of the destination country or vehicle. Replacement and Reissuance of Certificates In cases of technical errors, loss, damage, or the need for amendments, certificates may be replaced with new ones indicating the previous number and date of issuance. Replaced certificates are canceled in the information systems of the State Consumer Service. Requirements for Forms and Language of Issuance International certificates are issued in Ukrainian, English, or the language of the destination/transit country. They must have a unique identification number, be signed by authorized persons, and be certified with the seals of the issuing authorities. The format of the documents may be single-page or multi-page with appropriate numbering. Appendices to the Certificate Issuance Procedure The order includes 15 forms of international certificates for various categories of food products, such as meat from various animal species, eggs, dairy products, honey, fish, and other products of animal and non-animal origin. Each form corresponds to specific requirements for the particular type of goods. Control and Registration The issuance and circulation of international certificates are controlled by the Deputy Minister of Agrarian Policy and Food of Ukraine. All issued documents are registered in the relevant logs, which are maintained in both electronic and paper form with a mandatory numbered and certified entry. Financial Aspects The procedure for issuing international certificates is carried out on a paid basis according to the current legislation of Ukraine. The cost of services is established in accordance with part seven of Article 60 of the Law of Ukraine on the Basic Principles and Requirements for Food Safety and Quality. Conclusion Order No. 2252 specifies detailed rules and procedures for the issuance of international certificates, ensuring that Ukrainian food products comply with international standards and the requirements of destination countries. This contributes to strengthening trust in Ukrainian products in the global market and […]

[:uk]Review of the EU legislation for 14/10/2024 – 21/10/2024[:][:uk]Analysis of Recent EU Regulations 1. Commission Regulation (EU) 2024/2730 This regulation […]

[:uk]Review of Ukrainian legislation for 14/10/2024 – 21/10/2024[:][:uk]Digest of Legislative Acts Resolution of the Cabinet of Ministers of Ukraine on the […]

[:uk]Review of the EU legislation for 21/10/2024[:][:uk]Overview of Recent EU Regulations Commission Regulation (EU) 2024/2730 This regulation establishes a […]

[: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 […]