Emergency Use Was Added to Turkey's Vaccination Regulations

Emergency Use Was Added to Turkey's Vaccination Regulations Emergency use was added to Turkey's vaccination regulations. Thus, coronavirus vaccines will be approved for emergency use. The provision of "Emergency Use Approval (AKO)" has been added to the Human Medicinal Products Licensing Regulation for vaccines within the scope of infectious diseases. Pharmaceuticals and Medical Devices Agency of Turkey’s, ‘Human Medicinal Products Licensing Regulation Amendment’, published in Official Gazette and is enacted. Accordingly, the following expressions were added to the Regulations on Medicinal Products for Human Use: “For vaccines, which are accepted by the World Health Organization or the Ministry within the scope of communicable diseases, which will be used in exceptional cases that seriously threaten public health and for which comprehensive data on efficacy, safety and quality cannot be provided yet, AKO can be given by the Authority until these data are provided.” In addition, AKO application cannot be made for changes in the therapeutic indications of a licensed product or for the addition of new ones. The work and transactions regarding AKO applications will be carried out in accordance with the provisions of the relevant guideline to be published in line with this regulation. The provisions of the said regulations will be enforced by the President of the Pharmaceuticals and Medical Devices Agency of Turkey.