As Ukraine transitions to MDR and IVDR, the government aims to use European electronic systems rather than developing its own. This approach seems reasonable, but is it feasible? One of the key innovations of MDR and IVDR is the Unique Device Identification (UDI) system and the EUDAMED electronic database. In Ukraine, the regulation of medical […]
The Law on labeling of medicines in Ukraine and notice of the competent authority
Dear colleagues,
Please pay attention that on January 18, 2025, Law of Ukraine No. 3910-IX, which prohibits advertising information on the labeling of medicinal products, will come into effect.
The Law bans the inclusion of any advertising information on the packaging of medicinal products, as well as information about other legal or physical entities that are not the manufacturer of the medicinal product or the Applicant (Marketing Authorization Holder).
In case of non-compliance with labeling requirements, the Ministry of Health of Ukraine will issue a decision to temporarily suspend the registration certificate for such medicinal products until their labeling is brought into compliance. Furthermore, retail and wholesale trade, as well as the import of medicinal products with advertising information or information about other legal or physical entities, is prohibited.
In November 2024, the Ministry of Health provided clarifications regarding the requirements of Law No. 3910, including:
- The inclusion of information that complies with the approved instructions for use,
- The use of trademarks (logos) of companies, including under license agreements,
- Contact information of the applicant’s representative regarding quality and safety issues,
- The circulation of medicinal product batches manufactured in accordance with the approved registration documents before January 18, 2025.
At the same time, please note that subordinate regulatory acts concerning the circulation of manufactured batches have not yet been adopted.
On January 16, 2025, the State Service of Ukraine on Medicines and Drugs Control published an informational notice regarding the importation of medicinal products into the customs territory of Ukraine.
The notice provides a summary of the quality control requirements for medicinal products, particularly concerning the conformity of batches manufactured prior to the implementation of changes with the approved (valid at that time) registration materials.
EN – Law 3910-IX (pdf)
EN – Letter DLS quality summary (pdf)
EN – Letter MoH on labeling (pdf)
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