Registrations

For the import and sale of medicines on the territory of Ukraine, it is necessary to conduct state registration, as well as fulfill the necessary quality requirements.

The requirements for documentation and the examination process are quite close to the European directives, however, there are a large number of national peculiarities that specifically affect all regulatory processes.

The registration applicant can be both a resident and a non-resident of Ukraine. According to the legislation, it is the Applicant who is responsible for the quality, safety and efficacy of the medicinal product when circulating on the territory of Ukraine.

When preparing the dossier, it is also necessary to take into account a number of points:

It is obligatory for the manufacturer to have confirmation of the GMP certificate in Ukraine.
The dossier is submitted in four copies.
Each copy of the dossier must be accompanied by a sample of the finished medicinal product.
The dossier should include quality control methods for the finished product, developed in accordance with the manufacturer's documentation and the requirements of current legislation.
The dossier must include instructions for medical use, presented in Ukrainian.
For packaging layouts, serious requirements are put forward in terms of font size (at least 7 Didot points), braille marking, etc.