New Ukraine GMP and distribution regulations

A joint order issued by the State Committee of Ukraine on Policy and Entrepreneurship and the State Inspection for Control over the Quality  of Medicinal Products means the introduction of new regulations for the  manufacture and distribution of drugs. The document is titled Joint  Order No 44/27 "On New Licensing Conditions for Conducting of Economic  Activity of Production, Wholesale and Retail Sale of Medicinal  Products."

According to Olexander Matinenko and Solomiya Lototska, of  UK-headquartered international law firm CMS Cameron McKenna, "the  principal change introduced by the Order is a manufacturer's obligation  to comply with Good Manufacturing Practice in the production of  medicinal products." They add that "an exemption is given only for the  production of traditional medicinal products."

Among the other changes instituted by the Joint Order, a local drug  manufacturer is permitted to produce compounds that are not currently  registered in the Ukraine and to act as a contractor for another  drugmaker. The storage of drugs during the distribution process, as well  as tracking the chain-of-custody, are tightened up. Other reforms  include the certification of employees.