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.
More detailed information can be found here - http://www.legalalliance.com.ua/rus/press/1881/
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