Announcement of the State Food and Drug Administration on the conversion of aloe pearl capsule prescription drugs to over-the-counter drugs (No. 115 of 2021)

According to the "Regulations for the Classification of Prescription Drugs and Over-the-Counter Drugs (Trial)" (formerly State Drug Administration Order No.
10), aloe pearl capsules 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
.
The relevant drug marketing authorization holders are requested to file with the provincial drug supervision and administration department for the revision of the label in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations before December 22, 2021, and notify the relevant medical institution of the revised content of the label in a timely manner , 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
.
Drugs manufactured since the date of the supplementary application for filing shall not continue to use the original drug inserts
.
Hereby announce
.
Attachment: 1.
Variety list 2.
Variety of non-prescription drug instructions template State Drug Administration September 23, 2021 State Drug Administration Announcement No.
115 2021 Annex 1.
docx State Drug Administration Announcement No.
115 2021 Annex 2 .
doc