高校问答演员燕妮 50多:请诸位帮我翻译一下，不要软件译的。
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Food & Drug Administration
Certificate of a Pharmaceutical Product
( ) - recommended by the WHO
No. of Certificate [ ( - - )] : ┌
Exporting (certifying) country [ ( ) ] : Republic of Korea ├
Importing (requesting) country) [ ] : └
1. Applicant (=Product-license holder) [ = ]
(This certificate shall not be issued to others than the product-license holder)
- Name :
- Address :
2. Name and dosage form of product [ ] :
2.1. Number of product license and date of issue [ ] :
2.2. Active ingredient(s) and amount(s) per unit dose [ ]
(For complete quantitative composition including excipients, see attached.)
2.3. Is this product licensed to be placed on the market for use in the
exporting country ?
Yes( ) fill out section A, omit section B. [A , B ] ┌ ?
No( ) omit section A, fill out section B. [A , B ] └ ?
A.1. Is this product actually on the market in the exporting country? [ ] :
Yes( ) / No( ) / Unknown( )
A.2. Is Summary Technical Basis of Approval appended ? [ ]
Yes( ) / No( )
A.3. Is the attached, officially approved product information complete and consonant with
the license ? [ ] : Yes( ) / No( ) / Not
provided( )
B.1. Why is marketing authorization lacking ? [ ]
not required ┌ (just Applicant's option, even possible) [ ] ( )
not requested (not reviewed for marketing) [ ] ( ) ├
under consideration [ ] ( ) ├
refused [ ] ( ) └
B.1.. Remarks (the reason not requesting registration) [ ] :
2.4. Status of product-license holder [ ]
a ( ) manufactures the dosage form [ ]
b ( ) consigns partially the manufacturing process to other company [ ]
In case of "b", the manufacturer's [ · ]
Name : ?
Address : ?
Consigned process : ?
3. Does the certifying authority arrange for periodic inspection of the
manufacturing plant in which the dosage form is produced ? [
] : Yes
Inspection of each dosage form is implemented by the administrative ※
authority under the provision of the Pharmaceutical safety Law.
3.1. Periodicity of routine inspection(years) [ ] : years
3.2. Has the manufacture of this type of dosage form been inspected ?
[ ] : Yes
3.3. Do the facilities and operations conform to the WHO-GMP ?
[WHO GMP ] : Yes
Attached, if necessary [ ] : ※ approved product information ( , × ) ○
----------------------------------------------------
Director
Pharmaceutical Safety Division
Pharmaceutical Safety Bureau
Food and Drug Administration
Certificate of a Pharmaceutical Product
( ) - recommended by the WHO
No. of Certificate [ ( - - )] : ┌
Exporting (certifying) country [ ( ) ] : Republic of Korea ├
Importing (requesting) country) [ ] : └
1. Applicant (=Product-license holder) [ = ]
(This certificate shall not be issued to others than the product-license holder)
- Name :
- Address :
2. Name and dosage form of product [ ] :
2.1. Number of product license and date of issue [ ] :
2.2. Active ingredient(s) and amount(s) per unit dose [ ]
(For complete quantitative composition including excipients, see attached.)
2.3. Is this product licensed to be placed on the market for use in the
exporting country ?
Yes( ) fill out section A, omit section B. [A , B ] ┌ ?
No( ) omit section A, fill out section B. [A , B ] └ ?
A.1. Is this product actually on the market in the exporting country? [ ] :
Yes( ) / No( ) / Unknown( )
A.2. Is Summary Technical Basis of Approval appended ? [ ]
Yes( ) / No( )
A.3. Is the attached, officially approved product information complete and consonant with
the license ? [ ] : Yes( ) / No( ) / Not
provided( )
B.1. Why is marketing authorization lacking ? [ ]
not required ┌ (just Applicant's option, even possible) [ ] ( )
not requested (not reviewed for marketing) [ ] ( ) ├
under consideration [ ] ( ) ├
refused [ ] ( ) └
B.1.. Remarks (the reason not requesting registration) [ ] :
2.4. Status of product-license holder [ ]
a ( ) manufactures the dosage form [ ]
b ( ) consigns partially the manufacturing process to other company [ ]
In case of "b", the manufacturer's [ · ]
Name : ?
Address : ?
Consigned process : ?
3. Does the certifying authority arrange for periodic inspection of the
manufacturing plant in which the dosage form is produced ? [
] : Yes
Inspection of each dosage form is implemented by the administrative ※
authority under the provision of the Pharmaceutical safety Law.
3.1. Periodicity of routine inspection(years) [ ] : years
3.2. Has the manufacture of this type of dosage form been inspected ?
[ ] : Yes
3.3. Do the facilities and operations conform to the WHO-GMP ?
[WHO GMP ] : Yes
Attached, if necessary [ ] : ※ approved product information ( , × ) ○
----------------------------------------------------
Director
Pharmaceutical Safety Division
Pharmaceutical Safety Bureau
Food and Drug Administration