Verkhovna Rada Launches Institute for Parallel Import of Medicines in Ukraine
On 1 January 2025, the Law of Ukraine No. 3860-IX dated 16 July 2024, "On Amendments to Certain Laws of Ukraine on Parallel Import of Medicinal Products” (the "Law No. 3860-IX"), have come into force.
This law introduces amendments to the Law of Ukraine "On Medicinal Products” (the "Law"), specifically incorporating provisions on the parallel import of medicinal products. In particular, the updated Law is expected to include Article 78, which will directly regulate parallel imports and its key aspects.
The parallel import of medicinal products will refer to their importation into Ukraine from a member state of the European Union or the European Free Trade Association, which is a party to the European Economic Area (EEA) Agreement. Such medicinal products must be authorised and released for circulation in the exporting country and comply with the legal requirements set forth by Ukrainian legislation.
The exclusive requirements for parallel imports include the following:
1. Identity or similarity to a medicinal product registered in Ukraine, meaning:
The same qualitative and quantitative composition concerning the active substance(s);
Availability in the same dosage form;
The same indications, concentration/dosage, and route of administration as the medicinal product registered in Ukraine;
A similar pharmaceutical form that does not result in any therapeutic difference compared to the medicinal product registered in Ukraine.
2. The parallel-imported medicinal product must be a reference or generic product in Ukraine and the exporting country.
The parallel import of medicinal products may be conducted exclusively by a business entity that already holds a license for importing medicinal products under the licensing conditions established by the Cabinet of Ministers of Ukraine and obtains an additional separate permit for parallel import from the State Administration on Medicinal Products.
Law No. 3860-IX also provides for establishing a State Register of Medicinal Products for Parallel Import—a unified state information system containing current and archived data on issued permits. The register will facilitate collecting, processing, storing, and protecting information on medicinal products imported under the parallel import procedure. The Cabinet of Ministers of Ukraine will approve the procedure for maintaining this register.
Although Law No. 3860-IX states that its provisions were to take effect on 1 January 2025, the necessary implementing bylaws have not yet been developed, preventing the new regulations from coming into force.
In this regard, the Ministry of Health of Ukraine has initiated a public discussion on the draft Decree "Some Issues of Implementation of the Law of Ukraine No. 3860-IX”, which proposes to approve provisions regulating the procedure for granting parallel import permits, including conditions for issuance, suspension, renewal, and cancellation of such permits.
According to Roman Isayenko, Head of the State Administration on Medicinal Products, the parallel import will not replace the existing procedure for importing and registering medicinal products in Ukraine. Parallel-imported medicines will not be available for sale in pharmacies. Instead, under a simplified procedure, Ukraine will be supplied with medicines urgently needed in exceptional circumstances, such as epidemics, emergencies, and martial law.