History and milestones

Опубліковано 10.06.2020 о 15:44

The State Service on Medicinal Products was established in September 15, 1992 under the authority of the Ministry of Health of Ukraine. However, only in 1996, with the adoption of the Law of Ukraine “On Medicines”, the State Service was obtained its legislative power.

In 2000 the State Department for Quality Control, Safety and Production of Medicines and Medical Devices had been formed at the Ministry of Health of Ukraine as a special structural unit in the field of quality control of medicines in Ukraine.

Since 2001, the modern effective vertical system of the state control of quality of medicinal products has been established and started fully operational and in Ukraine

In 2002, 27 Regional State Inspections and the Central Laboratory for Medicines Quality Analyzing had already been functioning in our country. There were about 600 professionals in the system of state medicines quality control, among them 11 PhD, 331 upper level professionals. The regulation and control carried out over the activities of more than 5 thousand business entities, which included 7949 pharmacies, 12074 pharmacy branches, 1167 warehouses and 6932 rural health posts. In 2003 pursuant to the Decree of the President of Ukraine “On measures to improve the Provision of the Population by Medicines and Medical products, as well as increasing the Efficiency of Public Administration in this Area” the State Service of Medicines and Medical Devices was established as a governmental body of state administration.

In 2003, the Program to Combat manufacture and distribution of falsified medicines for 2003-2008 was approved by the Resolution of the Cabinet of Ministers of Ukraine of July 17, 2003 № 1075 and in 2004 it was determined that circulation of medicines should be in accordance with GMP, GDP, GLP and GCP requirements, harmonized with relevant EU and WHO directives. In the same year was approved Rules for marketing of medicinal products in Pharmacies (Resolution of the Cabinet of Ministers of Ukraine of November 11, 2004 №1572).

During 2010-2011, in Ukraine have been introduced mandatory compliance with GMP/GDP requirements for national manufacturers and distributors of medicines products, procedures of inspection of medicines manufacture and wholesale trading of medicines were harmonized with European procedures. Since 2011, Ukraine has established a criminal offence for medicines counterfeiting.

On January 1, 2011 Ukraine joined to PIC/S

Since 2012, 10 laboratories equipped in accordance with WHO recommendations have been functioning in the structure of the State Service of Medical Services. The Central laboratory included in the WHO List of Prequalified Quality Control Laboratories, accredited by CE European Directorate for the Quality of Medicines (EDQM) and integrates into General European Official Network (GEON) of network of official medicines control laboratories (OMCLs).

The same year Ukraine became the first state to ratify Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health – Medicrime Convention. In 2013, Ukraine became a member of the European Pharmacopoeia. The procedure of licensing of medicinal products imported to Ukraine was introduced, that increased responsibility of foreign manufacturers for production quality.

In 2014, SUMDC quality management system is certified by TUVRheinland® (Germany), Auditors Company for compliance with the requirements ISO 9001:2008 standard.

During 2008-2014, the National regulatory authority in the sphere of medicines quality control was reorganizing and reforming which had resulted in establishment through the merger of the State Service for Drugs and the State Drugs Control Service in 2016.

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