Ukraine. Changes to the Procedure for Confirmation of Compliance of Pharmaceutical Production Conditions with GMP are Proposed

The Ministry has published on its official website a Draft Order on amending the procedure of confirmation of compliance of pharmaceutical production conditions with Good Manufacturing Practice (GMP), approved by the Ministry’s Order No.1130 of 27 December 2012.

The Draft Order proposes to approve the new edition of the procedure taking into account pharmaceutical risk levels during assignment of the revealed violations category based on the results of inspections for compliance of pharmaceutical production with GMP requirements.

Source: EY Ukraine