• Medicines

Non-automatic

• Protect human, animal or plant life and health; protect environment

Same as the "Administrative bodies"

• G/LIC/N/2/UKR/32

• The Resolution was adopted following the provisions of the Law of Ukraine of 16 July 2024 No. 3860 "On Amendments to Certain Laws of Ukraine Regarding Parallel Import of Medicines".

  
  

  Clause 78 of the Law of Ukraine of 28 July 2022 No. 2469 "On Medicines" (as amended by the Law of Ukraine No. 3860), provides that the procedure for issuing, amending, suspending, cancelling or terminating the validity of a permit for parallel import of a medicine shall be approved by the central executive authority responsible for the formation and implementation of state policy in the field of healthcare.

  
  

  Pursuant to the Resolution of the Cabinet of Ministers of Ukraine No. 166 of 14 February 2025, until the establishment of the central executive authority with special status responsible for implementing state policy in the field of development, market authorization, quality control, safety, and efficacy of medicines, as defined by the Law of Ukraine No. 2469 “On Medicines” of 28 July 2022:

  
  

  - the State Service of Ukraine on Medicines and Drugs Control shall be responsible for making decisions on issuance or refusal to issue permits for parallel import of medicines, as well as for suspension, cancellation or termination of such permits, and for exercising other powers related to state supervision and control over medicines imported into Ukraine as parallel import, as prescribed by the Law;

  
  

  - the State Enterprise “State Expert Centre of the Ministry of Health of Ukraine” shall consider applications and accompanying documents submitted by business entities for obtaining, cancelling or amending permits for parallel import of medicines.