Regulated The Procedure For Parallel Import Of Medicines

On February 14, 2025, the Cabinet of Ministers of Ukraine issued Resolution No. 166 amending the regulations on parallel import of medicines, in particular, the Regulation on Control over Compliance of Immunobiological Products Used in Medical Practice with the Requirements of State and International Standards (the “Regulation”) and the Procedure for State Quality Control of Medicines Imported into Ukraine (the “Procedure”).

The amendments to the Regulations clarify that only immunobiological products that meet the requirements of national and international standards, are registered in Ukraine or imported into Ukraine as parallel imports, included in the State Register of Medicinal Products or the State Register of Medicinal Products that are imported into Ukraine in parallel, and have undergone quality control in accordance with the procedure established by the Ministry of Health of Ukraine may be used in medical practice and diagnostics in Ukraine.

The amendments to the Procedure, in turn, outline the mechanism of state quality control of medicinal products imported into Ukraine as parallel imports.

Thus, medicinal products are imported into the territory of Ukraine as parallel imports on the basis of a permit for parallel import of medicinal products and a quality certificate issued by the manufacturer in the exporting country.

With respect to such medicinal products, in addition to checking the cargo for compliance with the customs declaration, the State Service of Ukraine on Medicines and Drugs Control (SMS) carries out:

  1. Visual inspection of medicinal products imported into the territory of Ukraine.
  2. Verification of the permit for parallel import of medicinal products.
  3. Verification of compliance with proper storage conditions of medicinal products during their transportation.
  4. Control of medicinal products, including verification of compliance of the application and attached documents for the medicinal product under which the permit for parallel import of medicinal products was granted with the medicinal products imported into the territory of Ukraine as parallel import.

Laboratory analysis

Meanwhile, the laboratory analysis of medicinal products imported into the territory of Ukraine for the purposes of parallel import, according to the indicators determined by the SMS, is carried out in the following cases:

  • Negative results of visual quality control.
  • Violation of the storage conditions for a batch of a medicinal product determined by its manufacturer (stated in the quality specification and indicated in the package leaflets and on the packaging) during transportation or storage, which could adversely affect the quality of the medicinal product.
  • Detection of non-compliance of such medicinal products with the materials submitted to the state control authority for obtaining a permit for parallel import of the medicinal product.
  • The fact of prohibition of circulation of other batches of the medicinal product that have been withdrawn from circulation in accordance with the procedure established by law within the last two years.
  • Receipt of official information from the competent regulatory authorities of other countries on violations of quality or safety requirements for the medicinal product.

In addition, the Resolution stipulates that until the day of establishment of the central executive body with a special status implementing the state policy in the field of creation, market authorisation, quality control, safety and efficacy of medicinal products:

  • The decision to issue or refuse to issue a permit for parallel import of a medicinal product, as well as suspension, termination, cancellation of such a permit and other powers of the state control body to exercise state supervision (control) over medicinal products imported into the territory of Ukraine as provided for by the Law of Ukraine “On Medicinal Products”, shall be made by the SMS.
  • The State Enterprise “State Expert Centre of the Ministry of Health of Ukraine” shall review the application and attached documents for a medicinal product imported into the territory of Ukraine as a parallel import, submitted by a business entity to obtain or cancel the permit for parallel import of a medicinal product, or to amend the submitted documents.