НThe Instruction ST-N of the Ministry of Health 42-4.0:2016 “Medical products. Proper production practice” , which was approved by the order of the Ministry of Health of Ukraine “On Amendments to the Order of the Ministry of Health of Ukraine dated February 16, 2009 No. 95” dated 07/29/2016 No. 798.

The adoption of the order is connected with the changes that have taken place in the legislation regulating the circulation of medicinal products in the European Union, namely the entry into force of some sections of 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.”

To the Instruction ST-N of the Ministry of Health 42‑4.0:2016 “Medical products. Good Manufacturing Practice” has been amended as follows:

–  Appendix 15 “Qualification and Validation” of the Guidelines was harmonized with the updated Appendix 15 “Qualification and Validation” of the EC GMP Guidelines, which came into effect in the European Union on October 1, 2015;

–  Appendix 16 ” Certification by a Qualified Person and Batch Release” of Part I of the Guidelines was harmonized with the updated Appendix 16 “Certification by a Qualified Person and Batch Release” of the GMP EC Guidelines, which came into effect in the European Union on April 15, 2016;

– part 3 of the Guidelines introduces three more normative documents that are harmonized with the documents of part III of the EU GMP Guidelines:

• Instruction ST-N MOZ 42-4.6:2016 “Medical products. Some provisions regarding active substances exported to Ukraine for the production of medicinal products” , which is harmonized with the document of the European Commission “Form of “written confirmation” regarding active substances exported to the European Union for human medicinal products, in accordance with Article 46b(2) Directive 2001/83/EC”;
• Instruction ST-N MOZ 42-4.7:2016 “Medical products. Establishing health exposure limits for use in risk identification in the case of the production of various medicinal products using technical means of general use” , which is harmonized with the document of the European Medicines Agency EMA/CHMP/CVMP/SWP/BWP/169430/2012 “Guideline on establishment of health impact limits for use in risk identification in the case of production of various medicinal products using technical means of general use”;
• Instruction ST-N MOZ 42-4.8:2016 “Medical products. Formalized general risk assessment for the purpose of establishing appropriate good manufacturing practice for excipients used in medicinal products for human use” , which is harmonized with the document of the European Commission “Recommendations of March 19, 2015 on the formalized general risk assessment for the purpose of establishing appropriate good manufacturing practice for excipients of substances used in medicinal preparations for humans” (2015/С 95/02).

Published based on the materials of www.diklz.gov.ua