Health Ministry of Ukraine has developed and released a draft order which provides for improvement of procedures for importation into the customs territory of Ukraine of unregistered medicines, substances, products "in bulk", samples of biological material for preclinical studies and clinical trials, as well as strengthening control over their target appointment. As director of the Department of Regulatory Policy in the drug market and products in the health care system, Valery Stec, the state reserves the functions of control over the targeted use of unregistered imported medicines. This will protect the honest manufacturer, a physician who undertakes a special responsibility, and the patient. From now on, as stipulated in the draft order, unregistered medicines could be imported into the customs territory of Ukraine only, without the right implementation, ie for preclinical studies and clinical trials, subsequent registration in Ukraine, to develop new drugs and analytical drug quality control, research , exhibiting at trade shows and forums, as well as to individual applications by citizens. Instrument registered a clear procedure for implementing this procedure. In particular, it stipulates that unregistered medicines can be imported solely for the resolution of MH of Ukraine (in addition, necessarily need a certificate of quality manufacturer!), Samples of biological material are imported in the presence of the newsletter of Ministry of Health about the purpose of entry and amount of material, etc. In each direction provides a list of required documents, which can be a convincing reason for the importation of unregistered medicines, substances, products in the form of "in bulk", the reference drugs for clinical trials, the standard samples.
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