Medicines, medical immunobiological products, blood products

Resolution of the Cabinet of Ministers of Ukraine 377 "Certain Issues Relating to the Distribution of Medicines, Medical Immunobiological Products and Blood Products During the Period of Martial Law" of 25 March 2026; (3 page(s), in Ukrainian)

The Resolution has been developed with the aim of ensuring proper state control over the quality of medicines, medical immunobiological products and blood products manufactured and supplied to Ukraine during the period of martial law, ensuring the re-registration process of medicines, as well as preventing the risk of medicines of inadequate quality, safety and efficacy from entering the Ukrainian market.

The Resolution introduces amendments to Resolution of the Cabinet of Ministers of Ukraine of 15 January 1996 No. 73 "On approval of the Procedure for control of compliance of immunobiological products used in medical practice with state and international standards", Resolution of the Cabinet of Ministers of Ukraine of 26 May 2005 No. 376 "On approval of the Procedure for state registration (reregistration) of medicines and the fees for their state registration (reregistration)", Resolution of the Cabinet of Ministers of Ukraine No 902 "On Approval of the Procedure for State Quality Control of Medicinal Products Imported to Ukraine" of 14 September 2005 and Resolution of the Cabinet of Ministers of Ukraine No. 1446 "Some issues of state registration of medicines, vaccines or other medical immunobiological products for the treatment and/or specific prevention of acute respiratory disease COVID-19 caused by the SARS-CoV-2 coronavirus, subject to for emergency medical use" of 29 December 2021.

In particular, it is established that for a period of six months from the date of entry into force of this Resolution:

·        applications for the re-registration of medicines, the validity of registration certificates of which expired (or expires) during the period of martial law and has been extended for one year (until 1 January 2028), shall be submitted to the Ministry of Health;

·        where active pharmaceutical ingredients (APIs), excipients and packaging materials not included in the registration dossier of the respective medicine are used in the manufacture of finished medicines, the applicant shall introduce the relevant changes to the registration dossier;

·        the manufacture of finished medicines using active pharmaceutical ingredients (APIs), excipients and packaging materials not included in the registration dossier of the respective medicine is permitted;

·       the placing on the market and use of registered finished medicines manufactured and released using active pharmaceutical ingredients (APIs), excipients and packaging materials not included in the registration dossier of the respective medicine shall be permitted until the expiry date of such medicines.