Announcement of the State Food and Drug Administration on the conversion of four drugs including Shufeng Jiedu capsules into over-the-counter drugs (No. 90 of 2021)

According to the "Regulations for the Classification of Prescription Drugs and Over-the-Counter Drugs (Trial)" (formerly Order No.
10 of the State Drug Administration), after the State Drug Administration organized demonstration and approval, 4 kinds of drugs including Shufeng Jiedu Capsules were 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 relevant drug marketing authorization holders are requested to submit a supplementary application for the revision of the label in accordance with the "Administrative Measures for Drug Registration" and other relevant provisions to the provincial drug regulatory authority for the record, and notify the relevant information of the revised content of the label in a timely manner 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
.
The prescription drug instructions of the double-span variety can continue to be used
.
Hereby announce
.
Attachment: 1.
List of varieties 2.
Template of non-prescription drug instructions.
State Drug Administration July 5, 2021.
State Drug Administration Announcement No.
90 in 2021.
Annex 1.
docx State Drug Administration Announcement No.
90 in 2021.
Annex 2.
docx