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Announcement of the State Food and Drug Administration on the conversion of Beiqi tablets into over-the-counter drugs (No. 14 of 2021)

 Last Update: 2021-07-07
 Source: Internet
 Author: User

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According to the "Administrative Measures for the Classification of Prescription Drugs and Over-the-Counter Drugs (Trial)" (formerly State Drug Administration Order No.
10), Beiqi tablets 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

Before April 17, 2021, the holder of the drug marketing authorization shall submit the revised drug insert sheet to the provincial drug regulatory authority for the record in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations, and promptly 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

Hereby announce
.

Attachment: 1.

List of varieties

2.
Templates for non-prescription drug instructions

State Food and Drug Administration

January 18, 2021

Announcement No.

14 of 2021 Annex 1.
doc of the National Medical Products Administration

Announcement No.

14 of 2021 Annex 2 of the National Medical Products Administration.

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