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On July 01, 2014 the State Service of Ukraine for Medicinal Products promulgated the draft order of Ministry of Health of Ukraine "On Amendments to the Procedure Prohibiting (Temporary Banning) and Restoring Movement of Medicinal Products in the territory of Ukraine"(hereinafter - the Project).
The document was developed with the aim of improving the legislation on the state quality control of active pharmaceutical ingredients (APIs).
In particular, it is proposed to supplement the effective Procedure Prohibiting (Temporary Banning) and Restoring Movement of Medicinal Products in the territory of Ukraine, approved by the Ministry of Health of Ukraine as of November 22, 2011 No. 809 by the following provision:
"Turnover of residues in active pharmaceutical ingredients, which have been registered in Ukraine and the validity of the registration certificate of which has expired, is not prohibited until the expiration of the shelf life of such active pharmaceutical ingredients."
As indicated in the accompanying documents to the Draft, the adoption of amendments to the act will ensure the continuity of the process of production of finished medicinal products, which, in its turn, will ensure the availability of essential domestic medicinal products for all categories of patients, the harmonization of Ukrainian legislation with the legislation of European Union.
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