Information on the submission of EAEU files in XML format

Please be advised that the file submitted in the framework of the EAEU at the PHC stage will be accepted in XML format. Detailed information about this procedure can be found in:

  1. Rules of registration and examination of medicinal products for medical use. The Resolution of the Council of the Eurasian Economic Commission № 78
    https://docs.eaeunion.org/docs/ru-ru/01418269/cncd_20072018_55
  2. Rules of registration and examination of safety, quality and efficiency of medical devices, Resolution No. 46 of the Council of the Eurasian Economic Commission
    https://docs.eaeunion.org/docs/ru-ru/01410768/cncd_12072016_46
  3. Resolution of the Board of the Eurasian Economic Commission of June 30th, 2017 No. 79 “On Requirements for Electronic Type of Applications and Documents of the Registration File Submitted for Registration and Examination of Pharmaceuticals for Medical Use”
  4. Resolution of the Board of the Eurasian Economic Commission of June 30th, 2017 No.78 ”On Requirements for Electronic Type of Applications and Documents of the Registration File Submitted during Registration and Examination of Safety, Quality and Efficiency of Medical Devices”

https://rseds.eaeunion.org/ru/#/solutions