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According to the Administrative Measures for the Classification of Prescription and Non-prescription Drugs (Trial) (formerly Order No.
10 of the State Medical Products Administration), after the demonstration and review organized by the State Food and Drug Administration, Lu Dang Ginseng oral liquid was converted from prescription drugs to over-the-counter drugs
.
The list of varieties (Annex 1) and the model leaflet for over-the-counter drugs (Annex 2) are published
together.
10 of the State Medical Products Administration), after the demonstration and review organized by the State Food and Drug Administration, Lu Dang Ginseng oral liquid was converted from prescription drugs to over-the-counter drugs
.
The list of varieties (Annex 1) and the model leaflet for over-the-counter drugs (Annex 2) are published
together.
Before September 27, 2023, the relevant drug MAH holders are requested to file with the provincial drug regulatory department on the revised instructions in accordance with the Administrative Measures for Drug Registration and other relevant provisions, and promptly notify relevant medical institutions and drug trading enterprises of the revised instructions
.
.
Other contents of the instructions other than those specified in the model leaflet for over-the-counter drugs shall be executed in accordance with the original approval documents
.
Where drug labels involve relevant content, they shall be revised
together.
Over-the-counter drugs produced from the date of filing shall not continue to use the original drug inserts
.
.
Where drug labels involve relevant content, they shall be revised
together.
Over-the-counter drugs produced from the date of filing shall not continue to use the original drug inserts
.
This is hereby announced
.
.
Attachments: 1.
List of varieties
List of varieties
|
serial number
|
name of article
|
Specifications (composition)
|
classify
|
remark
|
Double-cross reporting categories
|
|
1
|
Lu Dang ginseng oral liquid
|
Each vial contains 10 ml
|
Category A
|
Double span
|
Chinese medicine class 1
|
2.
Sample over-the-counter drug instructions
Sample over-the-counter drug instructions
State Food and Drug Administration
December 28, 2022
