July 2013

Amendments to the Licensing Terms for Import of Pharmaceuticals

On 30 May 2013, the Ukrainian Ministry of Health issued Order No. 453 (the "Order") under which the Licensing Terms for Import of Pharmaceuticals were amended.

The Order specifies that the licensee must keep and provide for relevant inspections of controlling authorities the documents confirming purchase, import, storage, transportation, wholesale trade (distribution), disposal or utilization of the pharmaceuticals.

Moreover, the licensee is to inform the State Pharmaceuticals Service of Ukraine on any amendments to the documents attached to the license application. In the event of such amendments the licensee must within 10 business days submit the relevant written notice as well as the documents or their copies, confirming these amendments.

Licensee is to establish a fully documented and effective pharmaceuticals quality control system which requires participation of management and employees from various departments in accordance with the Licensing Terms.

Pharmaceuticals import shall be performed under the contract with a foreign manufacturer or supplier and the owner of the pharmaceuticals registration certificate. The contract shall clearly identify the parties liable for the quality, safety and efficiency of the pharmaceuticals under the registration dossier and the laws.

In addition, the Licensing Terms are supplemented with annex 10 "Importer's Dossier" which must contain, inter alia, information on premises and equipment, quality control and internal audits (self-inspections).

New version of the Licensing Terms will come into effect on 1 December 2013.

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

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