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The “Regulation for the Licensing of Human Medicinal Products Amending the Regulation” of the Turkish Pharmaceutical Products and Medical Devices Agency, published in the Official Gazette, is promulgated.
In this context, these data are provided for vaccines that will be used in exceptional cases that seriously threaten public health, that are accepted by the World Health Organization or the Ministry in the field of communicable diseases and for which they are not yet available. provide comprehensive data on efficacy, safety and quality. The Authority can grant emergency use approval (AKO) ”, he added.
The AKO request cannot be made for changes in the therapeutic indications of a licensed product or for the addition of new ones.
The work and transactions relating to AKO applications will be carried out in accordance with the provisions of the relevant guideline that will be published in accordance with this Regulation.
The President of Turkey will carry out the provisions of the Agency for the Regulation of Pharmaceutical Products and Medical Devices.
(AA)
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