On 27 July 2024 a Law of Ukraine On Amendments to Certain Laws of Ukraine Concerning Parallel Import of Medicinal Products (the “Law”) came into force. The Law legalises limited parallel import regime for medicinal products as of 1 January 2025.
The Law will bring the following key changes:
- From 1 January 2025, the parallel import of medicines into Ukraine will be lawful.
- At first, it will be possible to import medicines into Ukraine from EU countries, Iceland, Liechtenstein, and Norway only.
- It will be allowed to import medicines identical or similar to those registered in Ukraine, or which are both reference or both generic both in Ukraine and in the exporting country;
- The parallel-imported medicines may only be distributed through hospital sales channels.
- The parallel importers must obtain permit for parallel import of medicines.
- The importers will submit data about each lot of imported medicines to the designated public body.
Exporting Countries
It will be possible to import medicines into Ukraine from EU or EFTA member states that are parties to the EEA – Iceland, Liechtenstein, and Norway (the “Exporting countries”).
The Cabinet of Ministers of Ukraine may expand the list of Exporting countries, but only after Ukraine becomes member of the European Union, and the provisions on national verification system come into force (not earlier than 2028).
Permitted sales channels for parallel imported medicines
The Law directly prohibits the sale of the parallel imported medicines in pharmacy chains. Therefore, the distribution of the parallel imported medicines will be possible through public tenders or private clinics.
Regulatory Requirements
1. Requirements for Parallel Importers
Parallel importer must hold a license to import of medicines and obtain a parallel import permit, which is issued for 5 years. To obtain the permit, a parallel importer must, among other things indicate the pharmaceuticals intended for parallel import and declare that the marketing authorization holder in the Exporting country is informed about the intention to conduct a parallel import of its products.
Until the pharmacovigilance requirements of the new Law on Medicines of 28 July 2022 enter into force, parallel importers will be obliged to ensure the functioning of the pharmacovigilance system in accordance with the Law on Medicines currently in force.
2. Requirements for Parallel Imported Medicines
It will be allowed to import medicines that have been designated and approved for use in an Exporting country under the following conditions:
- the parallel-imported medicinal product is identical or similar to the medicinal product registered in Ukraine; or
- parallel imported medicine and medicine registered in Ukraine are both a reference medicine or a both generic medicine both in Ukraine and in the Exporting country.
The parallel imported medicines will be subject to state quality control procedures.
3. Requirements for Packaging and Repackaging
According to the Law, a parallel importer may:
- repackage the outer packaging of the medicine, or
- use original foreign packaging with additional labelling in Ukrainian, or
- use original foreign packaging and supplement it with a copy of the Ukrainian translation of the labelling, leaflet, and a summary of medicinal product characteristics for each package of the medicine parallel imported into Ukraine.
Repackaging and/or relabelling can be done in Ukraine if the importer has a manufacturing license.
4. Further Expected Developments
The Ministry of Health still needs to develop procedure for issuing permits for parallel imports of medicines, which should clarify requirements for the importers.
The Ukrainian government also must develop bylaws for the maintenance of: (i) the Register of Marketed Medicines Imported into Ukraine and (ii) the Register of Parallel Imported Medicinal Products. Both registers will be an integral part of the State Register of Medicinal Products.
Until the Register of Parallel Imported Medicinal Products is established, information about parallel imported medicines will be maintained in electronic form. This measure would enable the parallel import mechanism to function even if the relevant register is not operational by 1 January 2025.
IP Considerations
Parallel imports and repackaging largely involve the protection by intellectual property rights. In Ukraine, trademarks are subject to the international principle of exhaustion of rights, meaning the owner of a trademark cannot control the original product that was previously marketed.
Although the trademark protection itself does not appear to be an obstacle for the parallel import of medicines into Ukraine, activities such as repackaging or overstickering potentially infringe the rights of the trademark owners. Ukrainian law contains a reservation to the principle of exhaustion of rights, which allows a trademark owner to prohibit use of a trademark for legitimate reasons, particularly in cases of change or deterioration in condition of goods.
While there is not yet sufficient court practice in Ukraine on the application of the “legitimate reasons” reservation, the EU courts have developed a significant practice in disputes with parallel importers, which Ukrainian courts could potentially consider, and thus may serve as guidance for Ukrainian businesses.
For more information on pharmaceutical sector regulation including medicines parallel import in Ukraine, contact your CMS advisor or our local CMS team: Borys Danevych, Maria Orlyk.
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