On February 3, 2021, the Cabinet of Ministers approved the Procedure for the formation of a list of unregistered medicines (by international non-proprietary names) that can be imported into the territory of Ukraine.
The order was adopted after the amendments to the Law “On Medicines” regarding the state registration of medicines under obligations were passed by the parliament.
According to the approved procedure, proposals for the formation of the list, amendments to it can be submitted by:
1) central executive authorities, regional and city administrations;
2) a person authorized to carry out centralized health protection measures at the expense of state and local budgets;
3) a specialized procurement organization;
5) health care institutions;
6) civil society institutions.
Together with the proposal must be provided:
1) a submission letter in any form, which contains information about the medicinal product;
2) a copy of the document confirming the registration of the medicinal product in the USA, Switzerland, Japan, Australia, Canada or registration by the competent EU authority under a centralized procedure and is applied on the territory of one of such countries;
3) copies of the instructions for use of the medicinal product.
The decision on approval and recommendations on the inclusion of an unregistered medicinal product in the list or refusal to approve the inclusion of an unregistered medicinal product is made by the Ministry of Health within 10 working days from the date of receipt of the letter and documents.
Refusal to approve the inclusion of an unregistered medicinal product in the list may be accepted if there are alternative drugs for the prevention and/or treatment of the corresponding diseases in Ukraine; the need for unregistered medicinal products in Ukraine is not limited, that is, the medicinal product is intended for use by a large number of patients; unregistered medicinal products are not approved for use in the countries specified above; unregistered medicinal products are not included in the nomenclature of medicinal products approved by the Ministry of Health.