The article about “Emergency Use Approval (AKO)” has been added to the Regulations on Licensing of Medicinal Products for Human Use published in the Official Gazette.
The regulation published in the Official Gazette included the following articles;
“For vaccines to be used in exceptional cases that seriously threaten public health, which are accepted by the World Health Organization or the Ministry within the scope of communicable diseases 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. AKO application cannot be made for changes in the therapeutic indications of a product or for the addition of new ones. The work and transactions regarding AKO applications are carried out in accordance with the provisions of the relevant guideline to be published in accordance with this Regulation.
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Also, in the Special License Files and Conditions section, “AKO applications; It refers to the application file prepared in accordance with Part I and, when necessary, Part III of this Annex, with all the data that the applicant can provide regarding the effectiveness, safety and quality of the product.