Ukrainian law that enables parallel import of medicines in Ukraine from 1 January 2025 has entered into force (Law of July 16, 2024 No. 3860-IX). The possibility of parallel import was already provided for by the Law of Ukraine “On Medicines”, but this mechanism should have started working much later. In times of war, the need for this mechanism is very acute, so Ukrainian parliament decided to launch parallel import from 2025. Parallel import provides the import of medicines into the Ukraine not only through official exporting manufacturers, but also through dealers authorized by the manufacturer.
Conditions. Parallel import applies only under the following conditions:
- the imported medicines are identical or similar to those registered in Ukraine; or
- the imported medicines are simultaneously reference medicines or generics both in Ukraine and in the exporting country.
Distribution channels. Parallel imported medicines cannot be sold in pharmacies, so they can only be distributed through the hospitals or through the state tenders.
Exporting countries. It will be possible to import medicines into Ukraine from EU member states and Iceland, Liechtenstein and Norway (being the states-members of the European Free Trade Association, that are parties to the Agreement on the European Economic Area). The Cabinet of Ministers of Ukraine may expand the list of exporting countries after Ukraine becomes member of the European Union.
Licensing. Parallel importers having a license for import of medicines must obtain a permit for parallel import, to be renewed every 5 years, and must ensure the functioning of the pharmacovigilance system.
The Law provides for the creation of the State Register of Parallel Import Medicinal Products, which will become an integral part of the State Register of Medicinal Products.
Labeling and packaging. A parallel importer may (1) repack the outer packaging of the medicine, or (2) use the original foreign packaging with additional labeling in Ukrainian, or (3) use the original foreign packaging and supplement it with a copy of the Ukrainian translation. Repackaging and/or relabeling can be carried out in Ukraine if the importer has a manufacturing license.