Announcement of the State Food and Drug Administration on the conversion of compound Banlangen Granules into over-the-counter drugs (No. 58 of 2021)

According to the "Administrative Measures for the Classification of Prescription Drugs and Over-the-Counter Drugs (Trial)" (formerly State Drug Administration Order No.
10), the compound Banlangen Granules have been transformed from prescription drugs into non-prescription drugs after the State Drug Administration organized demonstration and approval
.
The list of varieties (Annex 1) and the template of non-prescription drug instructions (Annex 2) are released together
.
Before July 24, 2021, the holder of the relevant drug marketing authorization shall submit a supplementary application for the revision of the drug label in accordance with the "Administrative Measures on Drug Registration" and other relevant regulations, and submit it to the provincial drug regulatory authority for the record, and promptly notify the relevant contents of the revision of the label Medical 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
.
Drugs manufactured since the date of the supplementary application for filing shall not continue to use the original drug inserts
.
Hereby announce
.
Attachments: 1.
List of varieties 2.
Templates of non-prescription drug instructions.
State Drug Administration April 25, 2021.
State Drug Administration Announcement No.
58 in 2021.
Annex 1.
doc State Drug Administration Announcement No.
58 in 2021.
Annex 2.
doc