The State Service of Ukraine on Medicines and Drugs Control informs that the Ministry of Health of Ukraine has adopted (by the order of the MoH dated 04 May 2020 № 1023) the Guidelines СТ-Н МОЗУ 42-4.0:2020 “Medicinal Products. Good Manufacturing Practice” that correspond to the document «The Rules Governing Medicinal Products in the European Union. Volume 4. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use» and Guidelines СТ-Н МОЗУ 42-5.2:2020 “Medicinal Products. Principles of Good Distribution Practice of active substances for medicinal products for human use” that correspond to the document of the European Commission «Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)».
The Guidelines СТ-Н МОЗУ 42-4.0:2020 have been adopted to harmonize it with the revised Annex 2 and Annex 17 of the Guidelines of GMP EU and with the newly introduced Volume IV of "The rules governing medicinal products in the European Union" containing “Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products” introduced in the EU since 22 May 2018.
Volume IV of the Guidelines of GMP EU contains GMP principles and rules applied to manufacturing of advanced therapy medicinal products, including gene therapy medicinal products, somatic cell therapy medicinal products, and tissue engineered products. The revised Annex 2 and Annex 17 contain guidelines on interpretation of the GMP principles and rules for medicinal products defined by the Directive 2003/94/EC.
The Annex 2 has been revised in the EU as a result of adoption of the “Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products”, such as the previously adopted Annex 2 defined specific GMP rules regarding advanced therapy medicinal products. Besides, other regulations which define GMP requirements for medications cannot be applied to manufacture of advanced therapy medicinal products if it isn’t reflected in the «Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products».
Successful implementation of Process Analytical Technology (PAT), Quality by Design (QbD) and Quality Risk Management (QRM) in pharmaceutical manufacturing has shown that relevant combination of control in the manufacturing process commonly with timely monitoring and revision of previously defined indicators of materials ensure greater warranty of products quality than trials of ready-made products. It resulted in revision of the Annex 17 that has been adopted in alignment with the GMP EU guidelines.
The Guidelines СТ-Н МОЗУ 42-5.2:2020 “Medicinal Products. Principles of Good Distribution Practice of active substances for medicinal products for human use” are applied while distribution of active substances manufactured in Ukraine for sale on the internal market and for their export and import to/from Ukraine. The Guidelines extends to the business entities that carry on activities in distribution of active substances within Ukraine including enterprises that carry on activities in their manufacturing.
Guidelines СТ-Н МОЗУ 42-4.0:2020 “Medicinal Products. Good Manufacturing Practice” can be found via the following link https://www.dls.gov.ua/wp-content/uploads/2020/05/Настанова-СТ-Н-МОЗУ-42-4.0_2020.pdf
The Guidelines СТ-Н МОЗУ 42-5.2:2020 “Medicinal Products. Principles of Good Distribution Practice of active substances for medicinal products for human use” can be found via the following link https://www.dls.gov.ua/wp-content/uploads/2020/05/111Настанова-СТ-МОЗУ-42-5.2_2020.pdf