НАКАЗ МОЗ УКРАЇНИ 17.11.2016 № 1245 (із змінами) Про затвердження Порядку розгляду реєстраційних матеріалів на лікарські засоби, що подаються на державну реєстрацію (перереєстрацію), та матеріалів про внесення змін до реєстраційних матеріалів протягом дії реєстраційного посвідчення на лікарські засоби, які зареєстровані компетентними органами Сполучених Штатів Америки, Швейцарської Конфедерації, Японії, Австралії, Канади, лікарських засобів, що за централізованою процедурою зареєстровані компетентним органом Європейського Союзу

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 Procedure
Annex 1

Application 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 Union

Annex 2

LIST of registration materials to be submitted for review with the purpose of registration

Annex 3

CONCLUSION

Annex 4

Application 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 Union

Annex 5

Application 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 Union

Annex 6

LIST of materials about introduction of changes to registration materials submitted for review

Annex 7

LETTER OF CONFIRMATION

Annex 8

CONCLUSION on results of review of materials about introduction of changes to registration materials