After its publication in the newspaper “Official Gazette of Ukraine” dated September 18, 2015, No. 72, the Order of the Ministry of Health of Ukraine dated July 22, 2015, No. 452 entered into force. 

The order made changes to the “Procedure for confirmation of the compliance of the conditions of production of medicinal products with the requirements of good manufacturing practice” (order of the Ministry of Health of Ukraine dated 12.27.2012 No. 1130, registered in the Ministry of Justice of Ukraine on 01.21.2013 under No. 133/22665) , which allowed to improve certification procedure for the production of medicinal products for residents and non-residents, to introduce a clear mechanism for taking into account the risk levels of the medicinal product when assigning the classification of detected violations based on the results of inspections on the compliance of the production of medicinal products with GMP requirements. In addition, the Procedure provides examples of violations and assigning them to the established classifications; the procedure for preparing and evaluating the plan of corrective and preventive measures based on the results of the inspection was improved, etc.

Published based on the materials of www.diklz.gov.ua