AmCham Ukraine Healthcare Committee experts have been consistently raising certain concerns in terms of enactment of the Law of Ukraine #3910-IX “On Amendments to the Law of Ukraine “On Medicinal Products” regarding Labeling of Medicinal Products” dated August 21, 2024.
On January 17, 2025, the Cabinet of Ministers of Ukraine regulated the main issue by adopting Resolution #39 "On Amendments to the Procedure for State Registration (Re-registration) of Medicinal Products". As a result, a batch of medicinal products manufactured before January 18, 2025, with labeling that does not meet the new requirements, may be imported into Ukraine, circulated, and used until the expiration date indicated on the packaging.
Therefore, we look forward to the further support regarding the need to defining “information of an advertising nature”, providing expedited procedure for amending the registration materials for medicinal products on labeling of medicinal products as well as establishing a proper transition period.
AmCham is grateful to the Government, Ministry of Health of Ukraine, and Verkhovna Rada of Ukraine Committee on Public Health, Medical Assistance and Medical Insurance for taking into account the business community's position.
