The Cabinet of Ministers of Ukraine has approved a number of changes to the procedures for state registration and re-registration of medicines as well as their circulation for the period of martial law.
In particular, among the changes:
- Procedure for emergency state registration of medicines, medical immunobiological drugs, blood products supplied to Ukraine during martial law, under the obligation has been approved. This will make it possible to urgently register medicines (except those originating from the aggressor country) to provide medical institutions in Ukraine without the right to sell;
- Amendments to the Procedure for state registration (re-registration) of medicinal products have been introduced: applications for registration procedures, registration dossier materials and other documents can be submitted in e-form. This will simplify the registration process, as some applicant companies operate outside their offices;
- Validity of registration certificates for medicines, including those subject to procurement as a result of procurement procedures through international organizations and the State Enterprise Medical Procurement of Ukraine at public funds, which expired during martial law and within six months from the date of termination or the abolition of martial law has been extended. After the end of martial law, their re-registration will be carried out as usual;
- Amendments have been made to the Procedure for state quality control of medicinal products imported into Ukraine, which will simplify the procedure for issuing conclusions on the quality of medicinal products. It is also allowed to import registered medicines in foreign packaging for further sale.
The approved changes will alleviate the regulatory burden on the pharmaceutical market and allow to use all available opportunities for the supply and production of medicines, as well as contribute to the rapid filling of the market and providing the necessary medicines to the entire population of Ukraine and health care facilities preserving their quality, efficiency and safety.