Starting on 1 January 2025, the parallel import of medicines into Ukraine will come into force, allowing dealers that are authorised by manufacturers of medicinal products to import medicines in parallel with said manufacturers. The expected outcomes of this new regime are higher competition and lower prices for relevant medicines.
This change is introduced by the Law of Ukraine No. 3860-IX as of 16 July 2024 (as amended) “On Amending Certain Laws of Ukraine on Parallel Import of Medicinal Products” and is subject to a number of limitations, including the following:
a. Medicines eligible for parallel import
- an imported medicinal product that is identical or similar to the medicinal product registered in Ukraine; or
- imported medicinal products that are simultaneously reference medicinal products or generic medicinal products, both in Ukraine and in the exporting country.
b. Exporting countries
Parallel import is allowed only from EU member states, Iceland, Liechtenstein and Norway. The list of exporting countries may be expanded in the future.
c. Prohibition of pharmacy sales
The Law expressly prohibits the sale of medicines imported by a way of parallel import in pharmacies. Such medicines can be distributed only via hospital sales channels.
Regulatory approvals
The importer must obtain an import license, as well as a permit for parallel import, from the relevant state authorities in Ukraine. To this end, the importer should, inter alia, submit a declaration confirming that the owner of the registration in the exporting country is aware of the importer’s intention to engage in the parallel import of medicinal products. Should the importer choose to repackage medicinal products in Ukraine, such importer is required to also hold a manufacturing license. Medicinal products that are imported into the territory of Ukraine by way of parallel import should be included in a separate State Register.
Further administrative steps
The relevant authorities must approve the procedure for the maintaining of the State Register of Parallel-Imported Medicinal Products and implement the software for the registration of said products (until then, information on this type of medicinal products shall be maintained electronically).
By Olga Ivlyeva, Associate, Wolf Theiss
