Draft order of the Ministry of Health of Ukraine “Amending the Procedure of Confirmation of the Compliance of Manufacturing Conditions of Medicinal Products to the Requirements of Good Manufacturing Practice”

On August 14, 2019, a draft order was published on the website of the Ministry of Health of Ukraine, which provided for changes to the GMP confirmation procedure in Ukraine (MoH Order No. 1130 of December 27, 2012). The purpose of the changes is to ensure effective state control over the quality of medicines and to bring Ukraine’s legislation into line with EU law. Amendments to the GMP Conformity Procedure provide for harmonization with the Compilation of Community Procedures on Inspections and Exchange of Information of 03.10.2014 No EMA/572454/2014 Rev 17.

The amendments to the Procedure provide for updating of the requirements of the Ukrainian legislation for calculating the validity of the Certificate of GMP confirmation in accordance with the rules of the said document.

The compilation procedure and other EU inspection documents for compliance of the manufacturing conditions of the medicinal products with GMP requirements are carried out by the regulatory body of the PIC/S Member State only if there is an application for marketing authorization of the medicinal product in the EU country. In the future, the regulatory authority that issued the certificate carries out supervisory inspections relating to the manufacture of specific medicinal products that have been registered after an EU inspection. The current Procedure provides for the documentary recognition of certificates issued by the regulatory authorities of PIC/S Member States (including the EU), ie without carrying out inspections. At the same time, recently, some of the medicines submitted under the Certificate Recognition procedure in Ukraine are not registered in the EU. In view of these changes, the Procedure foresees, during the procedure of recognition by the State Service of the Certificate issued by the regulatory body of the PIC / S Member States (including the EU), documents confirming the marketing authorization of a medicinal product in the EU.

Also, on January 1, 2019, the PIC / S PI 040-1 Guideline on GMP Nonconformity Classification was adopted, in consequence of which the State Service is replacing Annex 10 to the Procedure. Amendments to the Procedure will ensure the transparency and compliance of the procedure for confirming compliance of the conditions of manufacture of medicinal products with the requirements of good manufacturing practice with the requirements of PIC/S and the EU.