April 2013

New Procedure for Quality Control of Pharmaceuticals

On 28 April 2013 the amendments to the Pharmaceuticals Law regarding the quality control procedure (the "Amendments") became effective.

Amendments introduce new state quality control requirements for pharmaceuticals imported to Ukraine. It is required for all pharmaceuticals imported into Ukraine for further sale or use in pharmaceuticals manufacturing (either before or after their release for free circulation in the customs territory of Ukraine).

In addition, the list of situations in which unregistered pharmaceuticals can be imported to the customs territory of Ukraine has been extended to include:

  • Transit through the territory of Ukraine;
  • Placing in a customs warehouse regime for subsequent re-export, but only for the pharmaceuticals which are (i) registered in the country of manufacturer, (ii) have a quality certificate; (iii) are not in contradiction with Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes Involving Threats to Public Health.

Re-export of such pharmaceuticals should be made no later than 6 months prior to their expiration date.

For further information please contact partner Oleksandr Padalka
and senior associate Anna Chornomorets

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