إجراء مقترح من أوكرانيا: منتجات صيدلة

The draft Order proposes to approve the Procedure for the Importation and Circulation of Unregistered Medicinal Products in Ukraine in order to: establish a uniform mechanism and regulate the procedures for the importation into Ukraine and circulation of unregistered medicinal products; specify the list of documents to be submitted to obtain confirmation for the importation of an unregistered medicinal product and the procedure for their review; establish specific cases in which unregistered medicinal products may be imported; lay down specific arrangements for the importation of unregistered medicinal products in emergencies that may pose a threat to public health. The draft Order prohibits the importation and use of falsified and substandard unregistered medicinal products, as well as medicinal products that are not registered in Ukraine and for which a regulatory decision to withdraw or suspend the marketing authorisation on safety grounds has been issued in the EU and/or the country of manufacture. The remaining shelf life of unregistered medicinal products imported into Ukraine must be at least half of the shelf life specified by the manufacturer where the specified shelf life is less than one year, or at least six months where the specified shelf life is more than one year. Upon the entry into force of this Order, Order of the Ministry of Health of Ukraine No. 237 of 26 April 2011 'On Approval of the Procedure for Importation of Unregistered Medicinal Products…