Joining the PIC/S timeline

2003

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

01.11.2004

Ukraine has submitted an official application to join PIC/S 

05.05.2009 – 06.05.2009

The PIC/S Committee held its regular meeting in Geneva, Switzerland, which was attended by representatives of the State Inspection for Quality Control of Medicines. During the meeting, relevant issues regarding Ukraine’s application for membership in PIC/S were discussed and an agreement was reached on the reactivation of Ukraine’s application

16.09.2009

In accordance with paragraph 2 of the order of the Cabinet of Ministers of Ukraine dated 16.09.2009 No. 48822/1/1-09 regarding the consideration of proposals from the European Business Association (paragraphs 140, 141), the State Inspectorate for Quality Control of Medicines is responsible for continuing Ukraine’s accession to PIC/S

04.02.2010

Order 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 evaluation audit, providing effective support and favorable conditions for the State Inspection 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 that meets the qualification requirements of PIC/S

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 of the Ministry of Health, legislation in the field of circulation of medicinal products and an audit of the inspection process of national manufacturers of medicinal products were conducted

08.11.2010

The decision to admit the State Service of Ukraine on Medicines and Drugs Control to PIC/S was unanimously adopted at the regular meeting of the PIC/S Committee in Kuala Lumpur (Malaysia)

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)

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 group, which included representatives from the Portuguese National Agency for Medicines and Medical Devices, the Taiwan Food and Drug Administration of the Ministry of Health and Welfare and the Danish Medicines Agency. During the reassessment, an audit was conducted of the quality management system of the central office of the State Service of Ukraine on Medicines and Drugs Control, legislation in the field of medicinal products circulation and the inspection process of national medicinal products manufacturers