Announcement of the State Food and Drug Administration on the conversion of Banlangen chewable tablets to over-the-counter drugs (No. 130 of 2020)

According to the "Administrative Measures for the Classification of Prescription Drugs and Over-the-Counter Drugs (Trial)" (State Drug Administration Order No.
10), Banlangen Chewable Tablets have been converted from prescription drugs to non-prescription drugs after the State Drug Administration has organized demonstration and approval
.
The list of varieties (Annex 1) and the template of non-prescription drug instructions (Annex 2) are released together

The relevant drug marketing authorization holders are requested to submit a supplementary application for the revision of the drug label in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations, and submit it to the provincial drug regulatory authority for the record, and promptly notify the revised content of the label Relevant medical institutions, pharmaceutical business enterprises 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

November 23, 2020

Announcement No.
130 of 2020, Announcement 1.
doc of the National Medical Products Administration

Announcement No.
130 of 2020, Announcement 2 of the National Medical Products Administration.