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The “emergency use approval” provision for Covid-19 vaccines was added to the Regulation on the Registration of Medicines for Human Use. According to this, “for vaccines that will be used in exceptional cases that seriously threaten public health and for which complete data on efficacy, safety and quality have not yet been provided, which are the basis for authorization, the Authority may grant AKO until this data is provided.
BREAKING NEWS: Regulations for the coronavirus vaccine | Video
According to the decision of the Turkish Pharmaceutical Products and Medical Devices Agency published in the Official Gazette, an amendment was added to the Regulation on Licensing of Medicinal Products, a substance related to the “Emergency Use Authorization (PCO)”. According to this, “For vaccines that are accepted by the World Health Organization or the Ministry in the field of communicable diseases, to be used in exceptional cases that seriously threaten public health and for which data cannot yet be provided complete information on efficacy, safety and quality, the Agency may provide AKO until this data is provided
According to the modification of the regulation, “AKO requests will not be made for changes related to the therapeutic indications of a licensed product or the addition of new ones.”
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