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According to the provisions of the Measures for the Classification and Administration of Prescription Drugs and Over-the-Counter Drugs (Trial Implementation) (formerly Order No.
10 of the State Drug Administration), after the State Drug Administration organized demonstration and review, omeprazole enteric-coated tablets were converted from prescription drugs to over-the-counter drugs
.
The list of varieties and their sample over-the-counter drug instructions are published
together.
10 of the State Drug Administration), after the State Drug Administration organized demonstration and review, omeprazole enteric-coated tablets were converted from prescription drugs to over-the-counter drugs
.
The list of varieties and their sample over-the-counter drug instructions are published
together.
The holders of the relevant drug marketing authorizations are requested to submit the revised instructions to the provincial drug supervision and management departments for the record before May 24, 2023, in accordance with the "Measures for the Administration of Drug Registration" and other relevant provisions, and promptly notify the relevant medical institutions, drug trading enterprises and other units
of the revised contents of the instructions.
of the revised contents of the instructions.
The contents of the instructions other than those specified in the model over-the-counter drug instructions shall be carried out
in accordance with the original approval documents.
Where drug labels involve relevant content, they shall be revised
together.
Drugs produced on the date of filing by the holder of the drug marketing authorization shall not continue to use the original drug instructions
.
in accordance with the original approval documents.
Where drug labels involve relevant content, they shall be revised
together.
Drugs produced on the date of filing by the holder of the drug marketing authorization shall not continue to use the original drug instructions
.
This is hereby announced
.
.
Attachments: 1.
List of varieties
List of varieties
|
serial number
|
Product name
|
Specifications (Composition)
|
classify
|
remark
|
Double-span declaration categories
|
|
1
|
Omeprazole enteric-coated tablets
|
10 mg
|
Class A
|
Double span
|
Chemical drugs 1 category
|
2.
Sample over-the-counter drug instructions
Sample over-the-counter drug instructions
State Food and Drug Administration
August 25, 2022
According to the provisions of the Measures for the Classification and Administration of Prescription Drugs and Over-the-Counter Drugs (Trial Implementation) (formerly Order No.
10 of the State Drug Administration), after the State Drug Administration organized demonstration and review, omeprazole enteric-coated tablets were converted from prescription drugs to over-the-counter drugs
.
The list of varieties and their sample over-the-counter drug instructions are published
together.
10 of the State Drug Administration), after the State Drug Administration organized demonstration and review, omeprazole enteric-coated tablets were converted from prescription drugs to over-the-counter drugs
.
The list of varieties and their sample over-the-counter drug instructions are published
together.
The holders of the relevant drug marketing authorizations are requested to submit the revised instructions to the provincial drug supervision and management departments for the record before May 24, 2023, in accordance with the "Measures for the Administration of Drug Registration" and other relevant provisions, and promptly notify the relevant medical institutions, drug trading enterprises and other units
of the revised contents of the instructions.
Pharmaceuticals, drugs, drug registration enterprisesof the revised contents of the instructions.
The contents of the instructions other than those specified in the model over-the-counter drug instructions shall be carried out
in accordance with the original approval documents.
Where drug labels involve relevant content, they shall be revised
together.
Drugs produced on the date of filing by the holder of the drug marketing authorization shall not continue to use the original drug instructions
.
Over-the-counter drugs Over-the-counter drugsin accordance with the original approval documents.
Where drug labels involve relevant content, they shall be revised
together.
Drugs produced on the date of filing by the holder of the drug marketing authorization shall not continue to use the original drug instructions
.
This is hereby announced
.
.
Attachments: 1.
List of varieties
Attachments: 1. List of varieties
List of varieties
|
serial number
|
Product name
|
Specifications (Composition)
|
classify
|
remark
|
Double-span declaration categories
|
|
1
|
Omeprazole enteric-coated tablets
|
10 mg
|
Class A
|
Double span
|
Chemical drugs 1 category
|
|
serial number
|
Product name
|
Specifications (Composition)
|
classify
|
remark
|
Double-span declaration categories
|
|
1
|
Omeprazole enteric-coated tablets
|
10 mg
|
Class A
|
Double span
|
Chemical drugs 1 category
|
serial number
Product name
Specifications (Composition)
classify
remark
Double-span declaration categories
1
Omeprazole enteric-coated tablets
10 mg
Class A
Double span
Chemical drugs 1 category
serial number
Product name
Specifications (Composition)
classify
remark
Double-span declaration categories
serial number
serial number
Product name
Product name
Specifications (Composition)
Specifications (Composition)
classify
classify
remark
remark
Double-span declaration categories
Double-span declaration categories
1
Omeprazole enteric-coated tablets
10 mg
Class A
Double span
Chemical drugs 1 category
1
1
Omeprazole enteric-coated tablets
Omeprazole enteric-coated tablets
Omeprazole enteric-coated tablets 10 mg
10 mg
Class A
Class A
Double span
Double span
Chemical drugs 1 category
Chemical drugs 1 category
2.
Sample over-the-counter drug instructions
2. Sample over-the-counter drug instructions
Sample over-the-counter drug instructions
State Food and Drug Administration
August 2022, 8
