A meeting of the working group on the development of regulatory legal acts for the implementation of the Law of Ukraine “On Medicinal Products”

On August 23, 2024, the first meeting of the working group responsible for the preparation, development, and revision of regulatory legal acts for the implementation of the Law of Ukraine dated July 28, 2022, No. 2469-IX "On Medicinal Products" took place. This working group was established in accordance with the directive of the Minister of Health, Viktor Lyashko, dated December 29, 2023, No. DM64/6-23, and was approved by the order of the State Service of Ukraine on Medicines and Drugs Control dated August 19, 2024, No. 1268.

The working group includes representatives from the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines: Natalia Volovyk, Deputy Director for Quality, Elina Kotova, Head of the Experimental Support Sector for the Development of Monographs on Medicinal Plant Materials, Nelya Kyshynets, and Olga Tymchenko, Senior Researchers of the State Pharmacopoeia of Ukraine Department.

During the meeting, several important issues were discussed, including:

• The development and submission to the Ministry of Health (MOH) of a draft order "Good Pharmacy Practice (GPP)" to ensure the implementation of the Law of Ukraine "On Medicinal Products."
• The development and submission to the MOH of a draft resolution of the Cabinet of Ministers of Ukraine "On the Approval of the Procedure for Verifying Compliance with Licensing Conditions by Business Entities Engaged in Wholesale and Retail Trade in Medicinal Products."
• The development and submission to the MOH of a draft order "On Amendments to the MOH Order dated February 16, 2009, No. 95 regarding the Guidelines 'Good Distribution Practice of Medicinal Products for Human Use.'"

The working group participants also discussed the distribution of responsibilities in the development of regulatory documents. Specifically, the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines staff will be involved in the development of the National Standard for Good Pharmacy Practice (GPP) and ensuring the consistency of terminology in the final versions of regulatory documents with existing standards and terms defined in the Law of Ukraine No. 2469-IX, the State Pharmacopoeia of Ukraine, and the standard ST-N MOH 42-4.0:2020 "Good Manufacturing Practice for Medicinal Products."

With extensive experience in standardization and the development of regulatory documentation, the specialists of the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines will be valuable contributors in the process of creating and aligning regulatory documents, ensuring their compliance with current standards and terminology.