April 2013

New Procedure for Examination of Registration Materials for Pharmaceuticals

On 16 April 2013 the Order of the Ministry of Health No. 3 became effective. This order approves a new version of the Order of the Ministry No. 426 approving the Procedure for the Examination of Registration Materials for Pharmaceuticals Submitted for State Registration (Re-Registration) as well as the Examination of Materials for Amendments of Registration Materials (the "Order").

The amended Order establishes the procedure for the examination of registration materials for pharmaceuticals, including immunotherapeutic products submitted for state registration (re-registration). It also regulates the examination of materials submitted for amendments of registration materials during validity of a registration certificate.

The Order specifies the new format of document filling, clarifies the examination stages, provides the updated approach for "bioequivalence" definition, new requirements regarding the form and content of profile submitted for examination, new requirements for expert analysis of registration materials for immunotherapeutic medicines, etc.

For further information please contact partner Oleksandr Padalka
and senior associate Anna Chornomorets

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