What are the requirements for documents submitted for state registration of APIs? Requirements specifically for the registration of APIs, as compared with Order No. 3, are currently absent in Order No. 460.

136

The applicant submits materials according to the list specified in Annex 12 to the Procedure for conducting expert evaluation of registration materials, approved by Order of the MoH dated 23.07.2015 No. 460. The applicant is guided by the requirements of current legislation, taking into account international standards and recommendations, for example the EMA guideline "Guideline on Active Substance Master File Procedure".

Regulatory references: http://zakon5.rada.gov.ua/laws/show/z1210-15

What are the requirements for documents submitted for state registration of APIs? Requirements specifically for the registration of APIs, as compared with Order No. 3, are currently absent in Order No. 460.

Forum "PHARMEXPERT 2026: pharmaceutical market in the new regulatory reality"

Forum "Clinical and preclinical studies in wartime: organization and development prospects"

Pharmaceutical forum "PHARMEXPERT 2025. eCTD and pricing in Ukraine – a strategic path to integration into the international regulatory space"

PHARMEXPERT 2024. Standards. Innovations. European integration