The Cabinet of Ministers of Ukraine has approved a number of changes to the procedures for state registration and re-registration of medicines and their circulation for the period of martial law, in particular:
– the procedure for emergency state registration of medicines, medical immunobiological drugs, and blood products supplied to Ukraine during martial law was approved. This will make it possible to urgently register medicines to provide medical institutions without the right to sell;
– changes were introduced to the procedure for state registration (re-registration) of medicinal products: applications for registration procedures, registration dossier materials, and other documents can be submitted online;
– registration certificates for medicines were extended, including those subjects to procurement based on the results of the procurement procedure through international organizations and the State Enterprise “Medical Procurement of Ukraine” for state funds, which expired during martial law and within six months cessation or abolition of martial law. After the end of martial law, their re-registration will be carried out as usual;
– amendments were made to the procedure for state quality control of medicinal products imported into Ukraine, which will simplify the procedure for issuing opinions on the quality of medicinal products. It is also allowed to import registered medicines in foreign packaging for resale.
The approved changes will alleviate the regulatory burden on the pharmaceutical market and allow to use of all available opportunities for the supply and production of medicines, as well as help to quickly fill the market and provide the necessary medicines to the entire population and health care facilities of Ukraine.