Announcement of the State Food and Drug Administration on the conversion of three kinds of drugs including Siji Antiviral Mixture into over-the-counter drugs (No. 137 of 2020)

According to the "Regulations for the Classification of Prescription Drugs and Over-the-Counter Drugs (Trial)" (State Drug Administration Order No.
10), and after the State Drug Administration's organization and verification and approval, three kinds of drugs including Siji Antiviral Mixture were converted from prescription drugs to non-prescription 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 insert sheet in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations, and submit it to the provincial drug supervision and administration department for the record, and notify the relevant contents of the revision of the insert sheet 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

Hereby announce
.

Attachment: 1.
List of varieties

2.
Templates for non-prescription drug instructions

State Food and Drug Administration

Announcement No.
137 (2020) of the National Medical Products Administration Annex 1.
doc

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

December 15, 2020