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According to the "Regulations for the Classification of Prescription Drugs and Over-the-Counter Drugs (Trial)" (formerly the State Drug Administration Order No.
10), after the State Drug Administration’s organization verification and approval, Jinzhen Granules and Fuke Baifeng Capsules have been transformed from prescription drugs into Over-the-counter drugs
.
The list of varieties (Annex 1) and the template of non-prescription drug instructions (Annex 2) are released together
The holders of the relevant drug marketing authorizations are requested to report the revised drug inserts to the provincial drug supervision and administration department for the record in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations before April 6, 2021, and notify the relevant medical practitioners of the revised contents of the inserts in a timely manner Institutions, pharmaceutical companies and other units
.
The contents of the non-prescription drug inserts other than those specified in the template inserts shall be implemented in accordance with the original approval documents
.
If the drug label involves related content, it should be revised together
Hereby announce
.
Attachment: 1.
List of varieties
2.
Templates for non-prescription drug instructions
State Food and Drug Administration
January 7, 2021
Announcement No.
3 of 2021 Annex 1.
doc of the National Medical Products Administration
Announcement No.
3 of 2021 Annex 2 of the National Medical Products Administration.
