Ukraine. Import of drugs to Ukraine: state registration

Drugs registered in Ukraine can be imported to Ukraine subject to availability of a manufacturer quality certificate.

The State Drug Inspectorate controls the import of drugs to the customs territory of Ukraine.Unregistered drugs can be imported to the customs territory of Ukraine for:
  • Pre-clinical and clinical trials; 
  • Registration of drugs in Ukraine (drug samples in pharmaceutical form); 
  • Exhibits at exhibitions, fairs, conferences etc. without the right to sell; 
  • Individual use by citizens. 
The procedure of import of unregistered drugs to the customs territory of Ukraine in order to carry out pre-clinical and clinical trials and state registration is approved by the Decree of the MHC of Ukraine dd. 17.01.2002 #13 according to which import of such drugs to the customs territory of Ukraine through state border entry points is not subject to sanitary control. For purposes of customs clearance for free circulation of products imported to the customs territory of Ukraine a drug quality certificate and a letter of the Centre authorized for this purposes by the MHC of Ukraine shall be submitted to customs authority carrying out such clearance.

In order to obtain such letter a business entity or a person authorized by it shall submit an application to the Centre indicating the purpose of import of an unregistered drug, its quantity, trade name (international unpatented name, if any), composition, pharmaceutical form, origin as well as an original and a copy of the quality certificate. The copy of the certificate is kept by the Centre and the original shall be returned to the business entity. The Centre examines information stated in the application and provides a letter to the customs authority confirming the purpose of import of an unregistered drug, its quantity, trade name (international unpatented name, if any), composition, pharmaceutical form, origin etc. For import into Ukraine of unregistered drugs which according to the legislation are defined as narcotics, psychotropic substances or precursors additionally to the letter of the Centre a permit (certificate) of the State Narcotics Control Committee of Ukraine for their import shall be obtained.

For a one-time import of unregistered drugs for exhibition or individual use purposes and in cases of acts of God, catastrophes or epidemics the permit is granted according to provisions of the Decree of the MHC of Ukraine dd. 15.05.1997 #143. The permit is issued by the MHC of Ukraine based on a letter to the name of the Deputy Minister with submission of documents determined for each case by the Decree.

Sending of narcotics, psychotropic substances or precursors and drugs having limited shelf life term and requiring special storage such as vaccines, serums, immunobiological preparations etc. for individual use purposes is prohibited.
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