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According to the "Administrative Measures for the Classification of Prescription Drugs and Over-the-Counter Drugs (Trial)" (State Drug Administration Order No.
10), and after verification and review organized by the State Drug Administration, budesonide nasal spray was converted from a prescription drug to an over-the-counter drug
.
The list of varieties and the template of non-prescription drug instructions will be released together
The holders of the relevant drug marketing authorizations are requested to submit to the provincial drug regulatory authority for the record of amendments to the insert sheet in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations before October 18, 2021, and notify the relevant medical institutions, medical institutions, and medical institutions of the contents of the amendments in the insert sheet in a timely manner.
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.
13 of 2021 Annex 1.
doc of the National Medical Products Administration
Announcement No.
13 of 2021 Annex 2 of the National Medical Products Administration.
