Announcement of the State Food and Drug Administration on the Conversion of Prescription Drugs for Deficiency Deficiency and Thirst-Quenching Agent into Over-the-Counter Drugs (No. 134 [2021])

According to the "Measures for the Classification and Administration of Prescription Drugs and Non-prescription Drugs (Trial)" (formerly Order No.

Relevant drug marketing authorization holders are requested to file with the provincial drug supervision and administration department on the revision of the instructions in accordance with the relevant provisions of the Measures for the Administration of Drug Registration and other relevant provisions before February 4, 2022, and promptly notify the relevant medical institutions and drug trading enterprises of the revised content of the instructions
.

The contents of the instructions other than those specified in the model instructions for over-the-counter drugs shall be implemented
in accordance with the original approval documents.
Where drug labels involve relevant contents, they shall be revised
together.
Drugs produced from the date of filing of the supplementary application shall not continue to use the original drug instructions
.

This is hereby announced
.

Attachments: 1.
List of varieties

2.
Model instruction manual for varieties of over-the-counter drugs

State Food and Drug Administration

November 5, 2021

Annex 1 of Announcement No.
134 of 2021 of the State Drug Administration.
docx

Annex 2 of the State Drug Administration Announcement No.
134 of 2021.
doc