Joining the PIC/S timeline

Joining the PIC/S timeline

2002. Conscious of need to expanse international cooperation, which can be achieved through harmonizing standards of quality assurance, uniformity in licensing the Government of Ukraine entrusts to develop and approve measures for Ukraine`s accession to Pharmaceutical Inspection Cooperation Scheme (PIC/S).

2003. The State Administration of Ukraine on Medicinal Products officially informed the PIC/S Committee of its intention to join to PIC/S.

2004. According to the decision of the Government of Ukraine, the MOH of Ukraine has to take steps to ensure the medicines circulation in accordance with GMP, GDP, laboratory and clinical practice, harmonized with corresponding directives EU and WHO. Besides, the MOH of Ukraine charged the State Administration of Ukraine on Medicinal Products  to take all necessary measures to ensure joining  into PIC/S. Declaring its intension to become a member of PIC/S on November 1,Ukraine  applied for PIC/S pre-accession and  paid in a registration fee according to PIC/S procedures. 

2009. At the PIC/S Committee Meeting, Geneva, Switzerland the actual issues regarding membership application of Ukraine in PIC/S were learning and there was reached an agreement on reactivation the application.

By its decision, the Government of Ukraine charged the State Inspection on Medicines Quality Control  to continue the procedure on acquiring PIC/S membership.

At the regular meeting, Uppsala, Swiss, Regulatory Authority of Ireland, appointed as a Rapporteur  represented information concerning correspondence of quality system to PIC/S requirements.  

March, 2010. Official РIC/S delegation visited Ukraine. During  the visit the delegation audited quality system of the Central Unit of the State Administration of Ukraine on Medicinal Products as well as legislative base on medicines circulation,  procedure of inspection for national medicinal products manufacturer. As a result of this audit –  the readiness of the Ukrainian regulatory authority for joining the PIC/S has been confirmed.   

On may, 2010 in Geneva, Switzerland at the PIC/S meeting after analyzing  the results of  the assessment of the State Administration of Ukraine on Medicinal Products was resolved to re-visit Ukraine to finalized evaluation. The visit took place on October 2010.  

On November 2010 in Kuala-Lumpur, Malaysia at the PIC/S Committee unanimously was made a decision to  join Ukraine to PIC/S.

On January 1, 2011 Ukraine joined to PIC/S

State-member of PIC/S is the State which created capacity body in the area of medicinal products quality control, a member of PIC/S. PIC/S presently comprises 49 participants authorities from all over the world, among them Germany, Italy, Ireland, France, Switzerland, Poland, USA, Argentina, Australia, Canada, Israel, Malaysia, Singapore, South Africa etc.

PIC/S is open for Authority having a comparable GMP inspection system. Cooperation within the framework of PIC/S demonstrates correspondence of national legislation in the area of medicinal products circulation to demands for PIC/S members as well as high professional level of our inspectors.

PIC/S partners (www.picscheme.org)  are the following international organizations

– World Health Organization;

– European Directorate for the Quality of Medicines & HealthCare;

– European Medicines Agency;

– United Nations International Children’s Emergency Fund etc.

National pharmaceutical sphere steadily integrates into the world pharmaceutical community and to health care system. Ukraine undertake a commitment on assurance safety, quality and effectiveness medicinal products on every stage their circulation in compliance for international requirement.