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On 04.07.2012 Verkhovna Rada of Ukraine adopted the Law #538-VI
"On amending certain laws of Ukraine (as regarding licensing
of drugs import and definition of the term "active
pharmaceutical agent" (further referred to as law). This law
made amendments to the Law of Ukraine "On licensing of certain
kinds of economic activity" and supplemented it with the
provision that the activity on import of drugs in Ukraine is also
subject to licensing as well as other kinds of activity.
For the purposes of implementing the provisions of the law on
imported medicines licensing relevant license conditions will be
developed.
To ensure compliance with European legislation importer of
medicines, which plans to import drugs into Ukraine, must have an
authorized representative or other legal entity, which would be
fully administratively and criminally liable in accordance with
national law for the quality, safety and efficiency of an imported
drug.
The authorized entity of the importer will have to ensure that
the quality if the drug, its safety and effectiveness meet the
requirements of the registration dossier. It is the importer in
case of withdrawal, disposal or destruction of the defective
medicines responsible for their proper organization.
On 26.07.2012 the law was signed by the President. The
provisions of the law on compulsory licensing of imports will take
effect on the 1st of March, 2013.
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