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MoH OF UKRAINE ORDER 17.11.2016 No. 1245 (as amended) On approval of the Procedure for review of registration materials for medicinal products submitted for state registration (re-registration), and materials on amendments to registration materials during the validity of the registration certificate for medicinal products registered by the competent authorities of the United States of America, the Swiss Confederation, Japan, Australia, Canada, and medicinal products registered under the centralized procedure by the competent authority of the European Union

06.05.2021 Updated 20.09.2021 8727 views
Registered at the Ministry of Justice of Ukraine on December 14, 2016 under № 1619/29749
On Approval of Procedure for Review of Registration Materials Pertinent to Medicinal Products Submitted for the State Registration (Re-Registration) and Materials about Introduction of Changes to Registration Materials during the Validity Period of Registration Certificate for Medicinal Products Registered by Competent Authorities of the United States of America, the Swiss Confederation, Japan, Australia, Canada and Medicinal Products Registered by Competent Authority of the European Union Through Centralized ProcedureDOC · 154 KB · 22.10.2026
Annex 1Application for the State Registration of Medicinal Product Registered by Competent Authorities of the United States of America, the Swiss Confederation, Japan, Australia, Canada and Medicinal Product Registered by Competent Authority of the European Union Through Centralized Procedure and Used at the Territory of These Countries or Member States of the European UnionDOC · 270 KB · 22.10.2026
Annex 2LIST of registration materials to be submitted for review with the purpose of registrationDOC · 41 KB · 22.10.2026
Annex 3CONCLUSIONDOC · 60 KB · 22.10.2026
Annex 4Application for Re-Registration of Medicinal Product Registered by Competent Authorities of the United States of America, the Swiss Confederation, Japan, Australia, Canada and Medicinal Product Registered by Competent Authority of the European Union Through Centralized Procedure and Used at the Territory of These Countries or Member States of the European UnionDOC · 101 KB · 22.10.2026
Annex 5Application for introducing changes to registration materials pertinent to medicinal product registered by competent authorities of the United States of America, the Swiss Confederation, Japan, Australia, Canada and medicinal product registered by competent authority of the European Union through centralized procedure and used at the territory of these countries or Member States of the European UnionDOC · 96 KB · 22.10.2026
Annex 6LIST of materials about introduction of changes to registration materials submitted for reviewDOC · 51 KB · 22.10.2026
Annex 7LETTER OF CONFIRMATIONDOC · 36 KB · 22.10.2026
Annex 8CONCLUSION on results of review of materials about introduction of changes to registration materialsDOC · 40 KB · 22.10.2026