Expertise of documents submitted to the State Service of Ukraine on Medicines and Drugs Control for issuance of the certifcate or conclusion on confirmation of compliance of medicinal products manufacture conditions with GMP requirements

According to the Statute of the State Service of Ukraine on Medicines and Drugs Control approved by the Resolution of the Cabinet of Ministers of Ukraine as of 12.08.2015 № 647 and the Order on conduct of confirmation of compliance of medicinal products manufacture conditions with GMP requirements approved by the Procedure of the Ministry of Health of Ukraine as of 27.12.2012 №1130 (hereinafter – Procedure) the State Service of Ukraine on Medicines and Drugs Control can involve representatives of enterprises, institutions, organizations, scientists and proffesionals (on agreement) to conduct laboratory analysis of quality of medicinal products samples, expertise, inspections and performance of other works.

In order to conduct expertise of requests and submitted sets of documents with further issuance of the certificate or conclusion on confirmation of compliance of medicinal products manufacture conditions with GMP requirements including applications for manufacture sites situated on the territory of coutries whose regulatory authorities are members of the PIC/S, the State Service of Ukraine on Medicines and Drugs Control involves the following state enterprises: SE «Ukrainian Pharmaceutical Quality Institute», SE «Central Laboratory for Drugs Quality Analysis and Medicinal Products».

GMP inspectors of the state enterprises are listed in the register of GMP inspectors of the State Service of Ukraine on Medicines and Drugs Control and their qualifications are confirmed in compliance with the quality system requirements of the State Service of Ukraine on Medicines and Drugs Control. SE «Ukrainian Pharmaceutical Quality Institute», SE «Central Laboratory for Drugs Quality Analysis and Medicinal Products» according to the Procedure documents of the quality system of the State Service of Ukraine on Medicines and Drugs Control have unified approaches to conduct expertise of applications on compliance medicinal products manufacture conditions with GMP requirements.