New Law of Ukraine "On Medicinal Products"
Recently the new Law of Ukraine No. 2469 "On Medicinal Products", adopted on July 28, 2022, came into force. However, its main provisions will be put into effect 30 months after the end of the martial law in Ukraine, and part of the provisions will be implemented gradually. In particular, on August 18, 2025, a rule will come into effect regarding the submission of the documents for the procedures related to the state registration of medicinal products in electronic form, in accordance with the standard of the electronic common technical document (eCTD).
Additionally, from January 1, 2028, provisions will be introduced according to which:
- - an inspection of the manufacture of the investigated medicinal product may be carried out in order to check compliance with the requirements of good manufacturing practice (GMP);
- - import of medicinal products being investigated on the territory of Ukraine is subject to licensing except for the active pharmaceutical ingredients;
- - registration of business entities, engaged in import, production and wholesale trade of active pharmaceutical ingredients, is carried out;
- - retail trade of medicinal products is carried out in compliance with the requirements of Good Pharmaceutical Practice (GPP), approved by the Ministry of Health, etc.
This law establishes a norm according to which the owner of a registration certificate on a medicinal product may be a legal entity registered in Ukraine or EU.
Law No. 2469 stipulates that the registration certificate on a medicinal product issued before the entry into force of this law and having a limited validity period, operates for the term, specified in this certificate.
The registration certificate on a medicinal product issued for unlimited period remains valid indefinitely after the entry into force of the law. However, it will be replaced by an extract from the State Register of Medicinal Products at a request of the owner of registration or their representative in Ukraine free of charge within 5 years from the date of entry into force of this law. The extract will be issued without introducing amendments into the registration materials and/or without requirements for provision of the additional materials.
In addition, medicinal products registered in Ukraine before the entry into force of this law may be put into circulation within 5 years from the date of entry into force of this law, that is, by August 18, 2027, and being in circulation by the end of their shelf life in accordance with the legislation, operated before the entry into force of Law No. 2469, without any prohibitions or restrictions applied for such reasons.
At the same time, we draw your attention to the fact that at the moment the provisions of Law of Ukraine No. 123 "On Medicinal Products" of April 04, 1996 remain in force.
In case you are interested in RA services related to registration of medicinal products in Ukraine, please contact our specialists from Regulatory Affairs Department.