Clarification of the MoH of Ukraine on the labeling of medicines

Previously, we informed you about the prohibition of advertising information on the labeling of medicinal products established by the Law of Ukraine No. 3910-IX “On amendments to the Law of Ukraine ‘On medicinal products’ regarding the labeling of medicinal products” (hereinafter referred to as “Law No. 3910”), which comes into force on January 18, 2025.

Law No. 3910 prohibits any advertising information on the packaging of medicinal products, as well as information about other legal or natural persons who are not the manufacturer of the medicinal product or the Applicant (holder of the registration certificate).

In case of violation of the labeling requirements, the Ministry of Health of Ukraine (MOH) makes a decision to temporarily suspend the validity of the registration certificate for such a medicinal product until its labeling is brought into compliance. Additionally, the retail and wholesale trade, as well as the import of medicinal products, whose labeling contains advertising information or information about other legal or natural persons, are prohibited.

Law No. 3910 has raised many questions regarding the application of its provisions in various situations.

The Ministry of Health has provided clarifications regarding the requirements of Law No. 3910, including:

• the inclusion of information that complies with the approved instructions;
• the placement of company trademarks (logos), including those granted under a licensing agreement;
• the inclusion of contact information for the Applicant’s (MAH’s) representative for quality and safety issues;
• the circulation of batches of medicinal products released before January 18, 2025, in accordance with the approved registration documents.

At the same time, we draw your attention that subordinate regulatory legal acts regarding the circulation of manufactured batches have not yet been adopted.

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We offer: 

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In addition to the main services, we also offer:

• translation of the scientific, medical, technical, and legal documentation;
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