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Accreditation, licenses

The Quality Management System (QMS) has been in place since the creation of the laboratory.

Official QMS score:

– national regulatory authorities (Ministry of Health of Ukraine, State Inspection, State Service of Ukraine on Medicines) – 7 times certification from 2000 to 2016;

– SE “Ukrmetrteststandard” – metrological assessment – 2 times (2010 and 2013);

– World Health Organization (WHO) – prequalification in 2010 and re-confirmation of prequalification in 2013 and 2016;

– European Directorate for the Quality of Medicines and HealthCare (EDQM) – Certification in 2012 and Continued Certification in 2016

– National Accreditation Agency (NAAU) – accreditation of the testing laboratory for compliance with ISO 17025 – 2018 requirements

Current certificates with the relevant attestation / accreditation are added.

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ДС Свідоцтво про атестацію+галузь_2016

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Додаток до галузі

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Атестат НААУ+сфера-01.06.2018

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WHOPIR_2016

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WHO Closing of Inspection-10-11 May 2016

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EDQM свідоцтво і галузь

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The Laboratory has a License for the right to purchase, store, transport, import into the territory of Ukraine, destruction, use of narcotic drugs (list 1 of table II and list 1 of table III), psychotropic substances (list 2 of table II and list 2 of table III), precursors (list 1 tables IV and list 2, IV) “List of narcotic drugs, psychotropic substances and precursors” (License No. 69 dated 04.08.2016, valid until 04.08.2021)

Copy of the License is below.

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Ліцензія на наркотики 2016

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