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Search results: 2
26 Aug 2024
EAEU system of good practices and pharmaceutical inspections on par with best global practices
Chinara Mambetalieva, Deputy Director of the EEC's Technical Regulation and Accreditation Department, spoke about the results and prospects of the Eurasian Economic Commission's work on regulating good pharmaceutical practices as part of regulating the common market for medicines, at the plenary session of the 9th All-Russian GMP Conference with international participation held in Ufa. The EEC representative noted that medicines circulation in the EAEU is regulated on par with the best international practices, including on issues of pharmaceutical inspections, which is one of the Commission's priorities in 2024-2025. The system of good practices (GxP) in the field of medicine circulation and uniform documents on pharmaceutical inspections create a uniform system of quality assurance of medicines and a basis for mutual recognition of the results of pharmaceutical inspections in the Eurasian Five countries. The EAEU GxPs continuously evolve and are regularly updated taking into account the practice of their application and the development of best global practices. Dmitry Rozhdestvensky, Head of the EEC Section of Coordination of Activities in the Sphere of Circulation of Medicines and Medical Products, took part in the panel session of the conference that considered issues of harmonizing national legislation with the Union's law in terms of conducting pharmaceutical inspections and initiating inspections as part of registration procedures. The 9th All-Russian GMP Conference with international participation is one of this year's key events in the field of good practices. The event is annually attended by manufacturers, representatives of regulators and pharmaceutical inspectorates from the EAEU Member States, as well as representatives of the WHO Regional Office for Europe and regulators from the EAEU observer countries.
26 Mar 2024
In the EAEU, certificates of conformity for toys issued before July 27, 2024 will be valid until the end of their validity period
The Board of the Eurasian Economic Commission approved the procedure for enacting amendments to the unified technical regulation of the Eurasian Economic Union on toys. The amendments establish detailed procedures for conformity assessment. It is possible to put toys into circulation in the EAEU customs territory with authorization documents that are certificates of conformity issued before July 27, 2024* and are valid until the end of their validity period. Circulation of such toys is allowed during their lifespan (service life). Such an opportunity will have a positive impact on the business environment, as it provides a "soft" transition for manufacturers, persons authorized by the manufacturer and sellers (suppliers) of toys to the updated conformity assessment procedures. For reference. *The effective date of the amendments to the technical regulation adopted by Decision No. 5 of the Council dated January 26, 2024.