The State Medical Service held the first major meeting with representatives of the pharmaceutical community in 2024. The meeting was a continuation of the discussion that took place recently at the Ministry of Health under the chairmanship of the Minister of Health of Ukraine Viktor Lyashko.
The key issue brought up for discussion was devoted to issuing conclusions on the quality of imported medicinal products based on the relevant applications that were submitted before the entry into force of the Resolution of the Cabinet of Ministers of Ukraine dated October 13, 2023 No. 1077 "On Amendments to Clause 31 of the Procedure for State Control of the Quality of Medicinal Products" means imported into Ukraine" (hereinafter - the resolution).
Anna Tazieva, head of the Licensing Department for the production of medicinal products, blood and certification, and Ivan Hnativ, deputy head of the Department - head of the certification department for the production of medicinal products, provided clarification on the requirements that will come into effect on April 17, 2024. Business representatives were concerned about problems that may arise in the event of a delay in extending the validity period of the GMP certificate or in issuing it, in particular, how to import drugs that have already been produced, since after the entry into force of the resolution, the import of drugs is prohibited without confirmation that the conditions for the production of drugs are valid in Ukraine to the requirements of proper production practices, including when re-importing medicinal products by one business entity. Also, the issuance of conclusions about the quality of the imported drug, including when it is re-imported by one business entity, without confirmation of the compliance of the conditions for the production of medicinal products with the GMP requirements in force in Ukraine, will not be issued based on applications that will be submitted from April 17, 2024.
Source: https://www.dls.gov.ua/news
