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Pharmaceutical Network December 7th, the State Drug Administration in the official website issued "on the plate blue root chewing tablets into over-the-counter drug announcement" (hereinafter referred to as "announcement"), according to the "prescription drugs and over-the-counter drug classification management measures (trial)" (National Drug Administration Order No. 10) provisions, by the State Drug Administration organization demonstration and review, plate blue root chewing tablets from prescription drugs to over-the-counter drugs.
list of varieties and model over-the-counter drug instructions. The
announcement requires that, by February 22, 2021, the holders of the relevant drug listing permits submit supplementary applications for revision of the drug instructions to the provincial drug regulatory departments for the record in accordance with the relevant provisions of the Measures for the Administration of Drug Registration, and promptly notify the relevant medical institutions, pharmaceutical enterprises and other units of the revised regulations.
, other contents of the instructions other than those stipulated in the model over-the-counter drug instructions shall be carried out in accordance with the original approval documents.
drug labels related to the relevant content, they shall be revised.
the original drug instructions for medicines produced as of the date of filing of the supplementary application.
prescription drug instructions for both varieties can continue to be used.
attached: list of varieties