Amendment - Regulation on Licensing Medicinal Products for Human Use Published

Amendment - Regulation on Licensing Medicinal Products for Human Use Published

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As per the Amending Regulation for Regulation on Licensing Medicinal Products for Human Use No. 31338 (“Amending Regulation”) published on Official Gazette of December 18 2020, the Emergency Use Authorization (EUA) clause has been added to the for Regulation on Licensing Medicinal Products for Human Use (“Regulation”). Therefore, vaccines, which will be used in exceptional cases that seriously threaten public health and are accepted as communicable diseases by the World Health Organization or the Ministry of Health for which comprehensive data on efficacy, safety, and quality as basis for licensing have not yet been provided, can be issued licenses by the Turkish Pharmaceuticals and Medical Devices Agency until these data are provided.

The work and transactions regarding the EUA applications are to be carried out in accordance with the provisions of a relevant guideline which will be published in line with this Amending Regulation. 

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