The Ministry of Health and the State Service of Ukraine for Medicines and Drug Control published a draft order that would amend the current Procedure for confirming compliance of the conditions for the production of medicines with the requirements of good manufacturing practice.
Good Manufacturing Practice (GMP) is a component of the quality assurance system that ensures that the production of medicines meets the standards, purpose and registration dossier. Compliance with GMP rules reduces even the risks of pharmaceutical products that cannot be eliminated during testing. GMP principles and rules are mandatory for all EU member states, and Ukraine approved the corresponding document in 2001.
New amendments to the Procedure are intended to bring the standards of state control over the production of medicines in accordance with the current legislation of the European Union. Significant updates will relate to the terminology – in accordance with the norms of the European Community collection of inspections and information exchange dated 03.10.2014 No. EMA / 572454/2014 Rev 17, new terms will appear – “critical violation”, “substantial violation” and “non-material violation”.
It also provides for simplification of procedures for issuing a certificate of compliance with GMP requirements. Such a certificate can be issued after the approval of the corrective action plan for violations indicating the terms of correction, while now documentary evidence of their elimination is required. In addition, according to the new requirements of EU law, medicines that are supplied through the certificate recognition procedure must now also be registered in the EU.
Now on the website of the Ministry of Health, a public discussion of these changes is ongoing. Their goal is to strengthen control over the quality of drugs and ensure transparency in the procedure for obtaining a certificate of good manufacturing practice.
