• Medicines

Non-automatic

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

Same as the "Administrative bodies"

• G/LIC/N/2/UKR/31

• The Resolution has been adopted to align the Licensing Conditions for Conducting Business Activities for the Production of Medicines, Wholesale and Retail Trade in Medicines, and Import of Medicines (except for Active Pharmaceutical Ingredients)" (hereinafter- the Licensing Conditions) with 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), specifically stipulates that parallel import of medicines shall be carried out by a business entity — a parallel importer — holding both a license for the import of medicines in accordance with the Licensing Conditions and a permit for parallel import of medicines.

  
  

  The amendments to the Licensing Conditions, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 352 of 28 March 2025 include, in particular:

  
  

  
  
  • the introduction of definitions for “parallel importer” and “parallel import of medicines”;
  
  
  • a clarification that parallel import of medicines is carried out by parallel importers holding a license for conducting business activities related to the import of medicines (excluding active pharmaceutical ingredients), and a permit for parallel import, obtained in accordance with the procedure established by law;
  
  
  • the addition of a new section “Requirements for parallel import” to the License Conditions.