Legal Alert: Ukraine Improves Fast-Track Registration Procedure for Medicines

December 06, 2017

On November 24, 2017 the improved Procedure for fast-track registration of medicines registered in the United States, Switzerland, Japan, Australia, Canada, and the European Union (centralized procedure) became effective.
 
The fast-track registration procedure started working back in January 2017 but turned out to be largely ineffective in practice due to excessively high level of required similarity between the Ukrainian and the reference dossiers. As a result, the regulator in many cases had no choice but to refuse localized dossiers that had insignificant discrepancies with the reference dossiers.

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