The guideline "Medicinal Products. Inspection and Verification of Compliance with Good Laboratory Practice (GLP)" has come into force in Ukraine.
In order to harmonize the regulatory framework in Ukraine on the inspection and verification of compliance with good laboratory practice (GLP), and on the basis of the European Union document: "Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP)" (Directive 2004/9/EU of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of compliance with good laboratory practice (GLP)), specialists of the State Expert Center of the Ministry of Health of Ukraine developed the guideline "Medicinal Products. Inspection and Verification of Compliance with Good Laboratory Practice (GLP)" ST-N MoHU 42–6.5:2024, approved by order of the Ministry of Health of Ukraine of 10.07.2024 No. 1199.
The guideline defines:
- procedures for monitoring compliance with good laboratory practice;
- procedures for conducting inspections of research institutions for compliance with GLP principles and general provisions on conducting study audits.
The text of the new document can be found on the website of the State Expert Center of the Ministry of Health of Ukraine in the section "Guidelines and methodological recommendations for conducting preclinical and clinical trials" at
