Announcement of the State Food and Drug Administration on the conversion of four drugs including Shenqi Wuweizi Capsules into over-the-counter drugs (No. 100 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, four kinds of drugs including Shenqi Wuweizi 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 contents of the revision of the label in time 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
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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
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Attachments: 1.
List of varieties 2.
Templates of non-prescription drug instructions.
State Drug Administration August 16, 2021 State Drug Administration Announcement No.
100 2021 Annex 1.
doc State Drug Administration Announcement No.
100 2021 Annex 2.
doc