The procedure for registration of medicines in Ukraine is in the stage of harmonization with the registration in the European Union, which leads to regular updating of the regulatory framework and some changes in the organization of work on registration. However, the new registration of pharmaceuticals for human use now includes three main stages: preparatory step, registration process and fulfillment

The procedure of registration, re-registration of medicines, as well as amendments to the registration dossier in Ukraine is somewhat different from the Russian procedures. For example, in Ukraine it is mandatory to comply with the IFU for a drug with the instructions of the reference European state (if the drug is registered in the EU), the national expert center of

As part of the consideration of the procedure for registration of medicines it is worth paying attention to such groups of drugs as reference (= Brand name), generic and biosimilar drugs. According to statistics, more than 60% of drugs on the Russian market are generics, or reproduced drugs. Definitions According to the Federal Law 61 reference drug is called a