On 15 September 1992, the State Inspectorate for Quality Control of Medicines was established under the Ministry of Health of Ukraine. The State Inspectorate received legislative regulation of its powers and activities in 1996 with the adoption of the Law of Ukraine ‘On Medicines’.
In 2000, the State Department for Control of Quality, Safety and Manufacturing of Medicines and Medical Devices was established within the Ministry of Health of Ukraine as a specialised structural unit in the field of quality control of medicines in Ukraine.
Since 2001, a modern and efficient vertical of the state quality control system for medicines has been established and started fully function in Ukraine.
The first strategic decisions and regulations were adopted:
- The Order of the Ministry of Health of Ukraine No. 497 dated 12.12.2001 approved the Procedure for Prohibition (Suspension) and Withdrawal from Circulation of Medicines in Ukraine;
- The Order of the Ministry of Health of Ukraine No. 428 dated 26.10.2001 approved the Instruction on the Preparation of Materials on Administrative Violations of the Legislation of Ukraine on Quality Assurance of Medicines;
- The Order of the Ministry of Health of Ukraine No. 436 dated 30.10.2001 approved the Instruction on the Procedure for Quality Control of Medicines in Wholesale and Retail Trade.
In 2002, there were 27 territorial state inspectorates and the Central Laboratory for Quality Analysis of Medicines in Ukraine.
In 2003, pursuant to the Decree of President of Ukraine, the State Service on Medicines and Medical Devices was established as a governmental body of public administration.
In the same year, the Cabinet of Ministers of Ukraine approved the Programme for Combating the Manufacturing and Distribution of Counterfeit Medicines for 2003-2008 by Resolution No. 1075 of 17.07.2003, and in 2004 it was determined (CMU Resolution No. 1419 of 28.10.2004) that the circulation of medicines in Ukraine should be carried out in accordance with the requirements of good manufacturing, distribution, laboratory and clinical practices harmonized with the relevant EU and WHO directives. In the same year, the Rules for Trade in Medicines in Pharmacies were approved (CMU Resolution No. 1572 of 17.11.2004).
In 2010-2011, Ukraine introduced Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidelines and procedures for inspecting the manufacturing of medicines and wholesale trade in medicines harmonized with the European ones as mandatory requirements.
Since 2011, Ukraine has introduced criminal liability for the falsification of medicines.
In 2011, the State Service of Ukraine on Medicines became a member of the PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme).
Since 2012, 10 laboratories have been operating within the structure of the State Service of Ukraine on Medicines equipped in accordance with WHO recommendations. The Central Laboratory is prequalified by WHO, accredited by the European Directorate for the Quality of Medicines of the Council of Europe and included in the General European OMCL (official medicines control laboratories) Network (GEON).
In the same year, Ukraine ratified the Council of Europe Convention on Counterfeiting of Medical Products and Similar Crimes Threatening Health (Medicrime Convention), which entered into force on 1 January 2016.
In 2013, Ukraine became a member of the European Pharmacopoeia. Thus, only medicines manufactured under GMP conditions and complying with the European Pharmacopoeia in terms of quality indicators are allowed to be marketed in Ukraine. A licensing procedure for imports of medicines was introduced, which increased the responsibility of foreign manufacturers for the quality of products.
In 2014, the quality management system of the State Service of Ukraine on Medicines was certified by the auditing company TUVRheinland® (Germany) for compliance with the requirements of ISO 9001:2008.
In 2008-2014, the state regulator in the field of quality control of medicines underwent a number of reorganizations and reforms.
The State Service of Ukraine on Medicines and Drugs Control was established by merging the State Service on Medicines and the State Service on Drugs Control in accordance with the Resolution of the Cabinet of Ministers of Ukraine No. 442 ‘On Optimization of the System of Central Executive Bodies’ dated 10.09.2014.
Today, the State Service of Ukraine on Medicines and Drugs Control is the central executive body that implements state policy in the spheres of quality control and safety of medicines, state market supervision of medical devices, and state regulation and control in the field of circulation of narcotic drugs, psychotropic substances and precursors, and combating their illicit trafficking.