Chronology of Ukraine’s accession to РIC/S

22.10.2018 – 26.10.2018

A standard reassessment of the State Service of Ukraine on Medicines and Drugs Control for compliance with PIC/S requirements (reassessment) was conducted by the PIC/S audit team which included representatives from the Portuguese National Agency for Medicines and Medical Devices, the Taiwan Food and Drugs Administration of the Ministry of Health and Welfare, and the Danish Medicines Agency. During the reassessment, the audit was conducted of the central office quality management system of the State Service of Ukraine on Medicines and Drugs Control, legislation in the field of medicines circulation, and the process of inspecting domestic medicines manufacturers.

01.01.2011

The State Service of Ukraine on Medicines and Drugs Control has become a full member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

08.11.2010

In Kuala Lumpur (Malaysia), at a regular meeting of the PIC/S Committee, a unanimous decision was made to admit the State Service of Ukraine on Medicines and Drugs Control to PIC/S.

03.10.2010 – 07.10.2010

Official visit of the PIC/S delegation to Ukraine, during which the implementation of corrective/preventive measures to address deficiencies identified during the previous audit conducted from 22-26 March 2010, was verified.

19.05.2010 – 20.05.2010

In Geneva (Switzerland), a regular meeting of the PIC/S Committee was held, at which the results of the audit of the State Inspection on Medicines’ Quality Control of the Ministry of Health were reviewed and a decision was made to conduct a follow-up visit.

22.03.2010 – 26.03.2010

Official visit of the PIC/S delegation to Ukraine, during which an audit of the quality system of the central office of the State Inspection on Medicines’ Quality Control of the Ministry of Health, legislation in the field of medicines circulation, and an audit of the inspection process of domestic medicines’ manufacturers were conducted.

04.02.2010

Assignment of the Cabinet of Ministers of Ukraine dated 04.02.2010 No. 4388/1/1-10 to the letter of the PIC/S Secretariat dated 15.01.2010 No. PSL02/2010 regarding ensuring the successful conduct of the assessment audit, providing effective support and favorable conditions for the State Inspection on Medicines’ Quality Control in order to prepare for the final stage of the PIC/S assessment procedure.

02.11.2009 – 03.11.2009

In Uppsala (Sweden), at a regular meeting of the PIC/S Committee, information was considered from the curator of Ukraine’s accession to PIC/S, which is the regulatory authority of GMP Ireland, regarding the existence of a quality system in the State Inspection on Medicines’ Quality Control that meets the qualification requirements of PIC/S.

16.09.2009

In accordance with paragraph 2 of the order of the Cabinet of Ministers of Ukraine dated 16 September 2009, No. 48822/1/1-09, regarding the consideration of proposals from the European Business Association (paragraphs 140, 141), the State Inspection on Medicines’ Quality Control is responsible for continuing Ukraine’s accession to PIC/S.

05.05.2009 – 06.05.2009

The regular meeting of the PIC/S Committee was held in Geneva (Switzerland), which was attended by representatives of the State Inspection. Topical issues regarding Ukraine’s application for membership in PIC/S were discussed during the meeting, and an agreement was reached on the reactivation of Ukraine’s application.

2005

Ukraine paid the registration fee in accordance with the approved PIC/S procedure.

01.11.2004

Ukraine has submitted an official application to join PIC/S.

28.10.2004

By Resolution of the Cabinet of Ministers of Ukraine No. 1419 dated 28 October 2004, “Certain Measures to Ensure the Quality of Medicines,” the Ministry of Health of Ukraine is obliged to ensure, starting from 1 January 2009, the circulation of medicines in accordance with the requirements of good manufacturing, distribution, laboratory, and clinical practices, harmonized with the relevant EU and WHO directives, and to take measures to ensure the accession of the State Service on Medicines and Medical Devices to PIC/S.

2003

The State Service on Medicines and Medical Devices sent an official letter to the PIC/S Committee regarding its intention to join PIC/S.