Announcement of the State Food and Drug Administration on the conversion of Liubo Zhangmin liniment prescription drugs into non-prescription drugs (No. 93 of 2021)

According to the "Administrative Measures for the Classification of Prescription Drugs and Over-the-Counter Drugs (Trial)" (formerly Order No.
10 of the State Drug Administration), the Liubo Zhangmin liniment was converted from a prescription drug to an over-the-counter drug after a demonstration and review organized by the State Drug Administration
.
The list of varieties and the template of non-prescription drug instructions will be released together
.
The holders of the relevant drug marketing authorization are requested to submit to the provincial drug regulatory authority for the record of the revision of the insert sheet in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations before April 8, 2022, and notify the relevant medical institutions, Units such as pharmaceutical business enterprises
.
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 produced from the date when the drug marketing license holder submits the filing shall not continue to use the original drug inserts
.
Hereby announce
.
Attachment: 1.
Variety list 2.
Variety non-prescription drug instruction sheet template (48 ml) 3.
Variety non-prescription drug instruction sheet template (82 ml) State Food and Drug Administration July 9, 2021 State Drug Administration Announcement No.
93 of 2021 Annex 1.
doc Announcement No.
93 of 2021 Annex 2 of the State Medical Products Administration.
doc Annex No.
93 Announcement No.
93 of 2021 of the State Medical Products Administration.
doc