Public Notice for Proposed Partial Revision of  
Management Regulations of Imported Drugs, etc.  
 
 
 
 
 
 
 
 
 
June, 2009  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Korea Food and Drug Administration  
Public Announcement No. 2009 -161 
 
 
We hereby announce, in accordance with provision s in Article 46 of the ‘Administrative 
Procedures Act’, the intent, reasons and the key elements of the partial revision of ‘Management 
Regulations of Imported Drugs, etc.’; to notify citizens in advance and to collect the public’s 
opinions.  
                                                                                                                                                                          
June 10, 2009  
                                                                                     
Commissioner,                                                                                                                                               
Korea Food and Drug Administration  
 
 
 
 
Public Notice for Proposed Partial Revision of  
Management Regulations for Imported Drugs, etc.  
 
 
 
1. Reason for the revision  
 
This revision has been proposed to reasonably improve the procedural controls of officially 
approved drugs etc. by adjusting customs formalities and the items to exempt from initial 
inspection;  by changing the management system of the raw materials of narcotics etc., bear’s gall 
and musk; therefore to improve and complement  loop -holes in the current management system.  
 
2. Key elements  
 
A. For reagents for the Automated Biochemical Analyzer, the quality inspection may be replaced 
with the certificate of conformity after field inspection and the inspection result report per the 
manufacturer’s serial num ber (Article 3 Subparagraph 11 of the Proposal).  
 
(1) The testing of the reagents for the Automated Biochemical Analyzer is not easy, because 
they have a short validity period and usually small amounts of products with different 
serial numbers are imported.  
(2) Replaced the quality inspection  with the certificate of conformity from the field inspection 
and the inspection result report per the manufacturer’s serial number .   
 
B. Improved the importing procedure for officially approved drugs by allowing them to get 
through the customs first, and then take the approval procedures later (Article 4 Paragraph 1 of 
the Proposal).   
(1) Currently, an approval procedure from a central competent authority is required for the 
drugs, subject to official approval to be able to get t hrough customs, causing public 
inconvenience such as costs for a bonded warehouse.  
(2) Improved the procedure by allowing customs clearance first and then taking the approval 
procedure later.  
 
C. Changed the importing of pharmaceutical raw materials , among the  raw materials of narcotics 
etc., used for the production of drugs to be customs cleared with permission from the 
Commissioner of the Korea Food and Drug Administration (Article 5 Paragraph 1 Subparagraph 
2 of the Proposal).  
  
(1) If the item is a raw  material  defined as one of the pharmaceutical raw materials in Article 2 
of the ‘ Act on the Control of Narcotics, etc.’, it can be customs cleared by submitting a 
standards and customs clearance probabilities report to the Chairman of the Korea 
Pharmaceutical Trad ers Association.  
(2) The permission for customs clearance from the Commissioner of the Korea Food and Drug 
Administration is required in order to strengthen the management of raw materials.  
 
D. Extended the scope of drugs subject to exemption from approval or inspection (Article 5 
Paragraph 2 of the Proposal).  
 
(1) Clarified the scope of exemption for drugs for external diagnosis.  
(2) Also exempted the initial approval for the following: drugs for academic, research, study 
and clinical trial purposes; drugs that confor m to assessment result of Good Manufacturing 
Practices  (GMP) per item after customs clearance.  
 
E. Changed the management system for bear’s gall and musk (Article 10 of the Proposal).  
 
(1) Changed the “Bear’s gall and Musk”, that are subject to CITES, to attac h the “CITES 
Certification Mark” issued by the Commissioner of the Korea Food and Drug 
Administration instead of Import Certification Mark issued by the Chairman of the Korea 
Pharmaceutical Traders Association.  
 
F. Excluded the Chinese medicine importers and manufacturers from the Chinese medicine 
quality inspection authorities (Appendix 1 -2.A. (3) of the Proposal).  
 
(1) It is needed to ensure the safety and the quality of imported Chinese medicines, as well as 
fairness of the inspection results.  
(2) Excluded the Chinese medicine importers and manufacturers from designating the Chinese 
medicine quality inspection authorities.  
 
 
 
G. Added imported Chinese medicines to the list of Chinese medicines subject to inspection.  
  (1) Added talc to the list of items subject to thorough examination.  
(2) Applied Chinese medicines that were stipulated in ‘The acceptable amounts and test 
methods of benzopyrene in herb medicines’ to the subjects for harmful substances testing.  
 
 
3. Presenting written opinions  
 
Any individual or group who  have opinion(s) about this proposed partial revision of 
‘Management Regulations of Imported Drugs, etc.’ are welcome to present opinions in writing to 
the Commissioner of the Korea Food and Drug Administration (Address: 194 Tongilro, 
Eunpyeong -gu, Seoul ( Postal Code: 122 -704) , CC: Pharmaceutical Safety Policy Division, 
Phone: 02 -3156 -8012, Fax: 02 -3156 -8029)  with the following information by June 29th, 2009:  
 
A. Opinions about this advanced notice (Whether you are for or against it and the reasoning)  
B. Yo ur name (For groups, name of the group and name of the representative), address and 
phone number   
C. Other references  
 
 
Attachment:  Public Notice for Proposed Partial Revision of Management Regulations for 
Imported Drugs, etc.   
Public Notice for Proposed  Partial Revision of  
Management Regulations for Imported Drugs, etc.  
 
 
We hereby revise a part of  ‘Management Regulations for Imported Drugs, etc.’ as follows:  
 
In Article 1, replace “Article 42 Paragraph 5” with “Article 42 Paragraphs 4 and 5”, and “ Article 
27 Paragraph 3 and Article 51 of Enforcement Regulations of the same Act ” with “ Article 27 
Paragraph 3 and Article 51 of Enforcement Regulations of the same Act, and Article 57 of the 
‘Act on the Control of Narcotics, etc.’ ”. 
 
In Article 2, replace “A rticles 49 and 51” with “Articles 49, 51 and Article 57 of the ‘ Act on the 
Control of Narcotics, etc.’ ”. 
 
Revise Article 3 Subparagraph 11 as follows.  
 
11. Q uality inspection record that falls one of the following items.  
 
A. The date and the results of the s elf quality inspection  per serial number  
B. Test report per serial number from the quality inspection authority  
C. Certificate of conformity from the field inspection and inspection report per serial number 
from the manufacturer (only for Article 5 Paragraph 2 S ubparagraph 2).  
 
In Article 3 Subparagraph 13, replace “by the provisions in Article 70” with “in accordance with 
Article 74”.  
 
In Article 4 P aragraph 1, replace “obtain the approval for the drugs per serial number from the 
Commissioner of the Korea Food a nd Drug Administration ( hereinafter referred to as the 
Commissioner of the KFDA) before the customs clearance, and shall submit, pursuant to the 
‘Electronic Trade Facilitation Act’,  the standards and customs clearance probabilities report to 
the Chairman o f the Korea Pharmaceutical Traders Association in a form of Electronic Data 
Interchange  in order to go through the customs formalities. ” with “shall go through the customs 
formalities by submitting, in accordance with the ‘ Electronic Trade Facilitation Act ’, the 
standards and customs clearance probabilities report to the Chairman of the Korea 
Pharmaceutical Traders Association in a form of Electronic Data Interchange ; and then shall 
submit an application for the official approval to the Commissioner of the Korea Food and Drug 
Administration ( hereinafter referred to as the Commissioner of the KFDA) within 3 days from 
the customs clearance.”.  
 
Add a proviso to Article 5 Paragraph 1 Subparagraph 2 as follows.  
However, if the item to import is a raw material sti pulated in Article 2 of the ‘ Act on the Control 
of Narcotics, etc.’, the importer shall obtain permission from the Commissioner of the KFDA, in 
accordance with Article 51 of the same Act, in order to go through the customs formalities .  
 In Article 5 Parag raph 1 Subparagraph 3, replace “to the inspection authority” with “to the head 
of the quality inspection authority”.  
 
 
 
In Article 5 Paragraph 2, replace “provisions in Paragraph1” with “Paragraph1”; “1” with “any 
one”; change the subparagraph of the same paragraph as follows.  
    2. Among the reagents for The Automated Biochemical Analyzer, the reagents for use of 
diagnose HIV, HBV, HCV and HTLV.  
 
In Article 5 Paragraph 2 Subparagraph 3, replace “test report” with “Inspection report”, and “the 
head of the inspection authority” to “the head of the quality inspection authority”.  
 
Change Article 5 Paragraph 2 Subparagraph 7 as follows and add Subparagraph 8 to the same 
paragraph as follows.  
  7. Drugs for academic, research, study and clinical trial purposes.  
8. Drugs that passed the conformity assessment by evaluating the operation status of the 
production and quality management standards in accordance with Article 24 Paragraph 1 
Subparagraph 6 and Article 26 Paragraph 2 of the ‘ Enforcement Regulations of the 
Pharmaceutical Affairs Act’ . 
 
In Article 5 Paragraph 3, replace “ according to the provision in the preceding Paragraph 1” with 
“according to the preceding Paragraph 1”, and “ Chinese medicines inspection authority” with 
“Chinese medicines quality inspection  authority”.  
 
In Article 6 Paragraph 1, replace “the Director of the National Institute of Food and Drug Safety 
Evaluation” with “the Commissioner of the KFDA, the Director of the National Institute of Food 
and Drug Safety Evaluation”.  
 
In Article 6 Paragr aph 2, replace “Chinese medicines inspection authority” to “Chinese 
medicines quality inspection authority”.  
 
Add a new proviso to Article 6 Paragraph 3 as follows.  
In addition, the organoleptic inspectors shall, pursuant to Paragraph 2, seal and stamp the  
samples taken and pass them to the Chinese medicines quality inspection authority.  
 
In Article 7 Paragraph 1, replace “approval authority” with “the Commissioner of the KFDA and 
the approval authority”, and “test report” to “inspection report”.  
 
In Articl e 7 Paragraph 2, replace “ The Commissioner of the KFDA, the head of Regional 
Administration and the head of the inspection authority” with “The Director of the National 
Institute of Food and Drug Safety Evaluation, the head of the Regional Administration a nd the 
head of the Chinese medicines quality inspection authority”.  
 
In Article 8, replace “inspection authority” with “Chinese medicines quality inspection 
authority”, and “ provisions in Article 5” with “ in accordance with Article 5”.   
Change the title of  Article 9 from “Measures concerning the non -conforming items” to “Notice 
for the non -conforming items”, and change the rest to be as follows.  
   The Commissioner of the KFDA and the head of the approval authority shall, if there are non -
conforming items a fter the inspection in accordance with the provisions stipulated in Articles 4, 
5, and 7, notify immediately the head of the Regional Administration, the director of the 
customhouse of the importer’s jurisdiction and the importer with a copy of the inspect ion report. 
However, in the case of Chinese medicines, the head of the other Chinese medicines quality 
inspection authorities shall be notified as well.  
 
Change the title of Article 10 from “The Endangered Species” to “Management of Endangered 
Species”; ch ange Paragraph 1 of the same Article to be as follows; make Paragraph 2 of the same 
Article to be Paragraph 3; add Paragraph 2 to the same Article.  
(1) Any person who has intended to sell imported bear’s gall or musk, in accordance with Article 
43 of the ‘ Pharmaceutical Affairs Act’, shall attach the CITES certificate mark issued by the 
Commissioner of the KFDA per sales unit.  
(2) Any person who has intended to attach the CITES certificate mark pursuant to the preceding 
Paragraph 1 shall submit an applicati on of the attached Form 1 to the Commissioner of the 
KFDA; the Commissioner of the KFDA shall verify the application and, if the application is 
suitable , shall issue the CITES certificate mark specified in Appendix 2.  
 
Change the title of Article 11 from “The Obligations for the Head of the Inspection Authority 
etc.” to “The Obligations for the Head of the Quality Inspection Authority etc.”.  
 
Change the title of Article 12 from “Revoke the Designation of the Inspection Authority etc.” to 
“Revoke the Design ation of the Quality Inspection Authority etc.”.  
 
Add Article 13 as follows.  
Article 13 (Review Period)  Pursuant to ‘Regulations for the issuance and management of 
directives, established rules etc’  (Presidential Directive No.248), the review period for ta king 
necessary measures such as to abolish or revise this notice after the Act and subordinate statute 
or changes in actual circumstances etc had been considered shall be until June 29th, 2012.  
 
Add “275” to Appendix 1 -1 A as follows.  
275. Talc  
 
In Append ix 1-1 B, replace “mycotoxins” with “mycotoxins, benzopyrene”, and add (5) as 
follows.  
(5) Benzopyrene test shall be applied to Chinese medicines that have been stipulated in ‘The 
acceptable amounts and test methods of benzopyrene in herb medicines’.  
 
In Appendix 1 -1 C, replace “the Minister of the Ministry for Health and Welfare” with “the 
Minister of the Ministry for Health, Welfare and Family Affairs”, and “existing Chinese medical 
books” with “existing Chinese medicine books”.  
 In Appendix 1 -2 A (3), re place “inspection authorities for Chinese medicines (manufacturers of 
Chinese medicines are only for harmful substances inspections)” with “quality inspection 
authorities for Chinese medicines (importers and manufacturers of Chinese medicines are 
excluded) .” 
 
In Appendix 1 -3 B, replace “inspection authorities” with “quality inspection authorities”, and 
“All Chinese medicines including the ones for KFDA” with “All Chinese medicines including 
the ones in Item A above”.  
Add Appendix 1 -4 B (5) as follows, and r eplace “Chinese medicines inspection authority” with 
“Chinese medicines quality inspection authority” in Appendix 1 -4 C. 
(5) The acceptable amounts and test methods of benzopyrene in herb medicines.  
 
Change the title of Appendix 1 -4 D from “Conduct the ins pection” to “Notify the inspection 
results”.  
 
In Appendix 1, replace “Equipments required for imported Chinese medicines inspection (related 
to Paragraph 2 Subparagraph B Item (1)” with “Equipments required for imported Chinese 
medicines inspection (relate d to Subparagraph 2 Item B (1))”.  
 
Change the title of Appendix 2 from “Import certificate mark (related to Article 10)” to “CITES 
certificate mark (related to Article 10)” as shown below.  
 
 
  
<Musk>        Certificate Number:000001         <Bear’s gall>       Certificate Number:000001  
 
Add the Attached Form 1 as an attachment.  
 
 
ADDENDUM  
 
Article 1 (Enforcement Date)  This notice shall enter into force on the date of announcement. 
However, the new provision in Article 5 Paragraph 2 Subparagraph 8 shall ente r into force from 
January 1st, 2010.  
Article 2 (Transitional Measures)  (1) The applications already received and the inspections are 
in progress by the quality inspection authorities, which had been designated by KFDA, Regional 
Administration, Research Ins titute of Public Health and Environment of the relevant city or 
province or the Commissioner of the KFDA, may follow the previous regulations until the date 
of enforcement of Article 5 Paragraph 2 Subparagraph 8.  (2) The cases that applied for import certi ficate marks to the Chairman of the Korea 
Pharmaceutical Traders Association at the time of the enforcement of this notice may follow the 
previous regulations.  
(3) If the product had already attached an import certificate mark issued by the Chairman of the  
Korea Pharmaceutical Traders Association at the time of the enforcement of this notice, the mark 
may be regarded as a CITES certificate mark that had been issued pursuant to this notice.   
Comparison of the New vs. Old Regulations  
 
 
Current  Revision  (Proposal) 
Article 1 (Purpose)  The purpose of these 
Regulations is to ensure the quality of imported 
drugs etc. and to establish proper management 
in the circulation of those drugs by laying 
down the details on customs clearance 
probabilities report, document s creation  for 
importation management, quality inspection 
authorities, methods and processes of quality 
inspection, and tips to make entries to the 
form; for drugs and sanitary aids that are being 
imported  (hereinafter referred to as “imported 
drugs etc”)  in accordance with Article 42 
Paragraph 5 , Article 43 Paragraph 1, Article 
69, Article 71 of  ‘Pharmaceutical Affairs Act’ 
and Article 27 Paragraph 3 and Article 51 of 
Enforcement Regulations of the same Act . 
 
 Article 1 (Purpose) ------------------------ --------  
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---------------------  being imported -----------------  
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-----------  in accordance with Article 42 
Paragraphs 4 and 5 ,----------------------------  
----------------------------------------------------  
Article 27 Paragraph 3 and Article 51 of  
Enforcement Regulations of the same Act, and 
Article 57 of the ‘Act on the Control of 
Narcotics, etc.’  
Article 2 (Application Scope)  This 
Regulations applies to the importing of drugs 
(including Chinese medicines) and sanitary 
aids in accordance with Art icle 42 Paragraph 1, 
Article 43 Paragraph 1 of  ‘Pharmaceutical 
Affairs Act’ and Articles 24, 26, 49 and 51  of 
the Enforcement Regulations of the same Act.  Article 2 (Application Scope) --------------------
-------------------------------------------------- -------
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------------ 49 and 51  and Article 57 of the ‘Act 
on the Control of Narcotics, etc.’  
 
Article 3 (Keeping the Importation 
Management Documents, etc.)  The following 
items shall be recorded on or attached to the 
importation management records.  
 1. ~ 10. (Omitted)  
 11. The date an d the results of the self quality 
inspection or the test report for quality 
inspection by the entrusted testing authority.  
 
 
 
 
 Article 3 (Keeping the Importation 
Management Documents, etc.) ------------------
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1. ~ 10. (The same as at present ) 
11. Quality inspection record that falls one of 
the following items.  
A. The date and the results of self quality 
inspection per serial number  
B. Test report per serial number from the 
quality inspection authority  
C. Certificate of conformity from the field 
inspection and the inspection result report per Current  Revision  (Proposal) 
 
  
12. (Omitted)  
 13. For the case of officially approved drugs, 
approval records by the provisions in Article 
70 of the Enforce ment Regulations of the 
Pharmaceutical Affairs Act.  serial number from the manufacture (only for 
Article 5 Paragraph 2 Subparagraph 2).  
12. (The same as at present ) 
13.-----------------------------------------------------  
------------ ----------------------  in accordance 
with Article 74 ---------------------------------------
--------------------------------------------------- . 
Article 4 (Officially Approved Drugs)  (1). 
Any person with the intent to import officially 
approved drugs shall  obtain the approval for 
the drugs per serial number from the 
Commissioner of the Korea Food and Drug 
Administration ( hereinafter referred to as the 
Commissioner of the KFDA) before the 
customs clearance, and shall submit, pursuant 
to the ‘ Electronic Trade  Facilitation Act’,  the 
standards and customs clearance probabilities 
report to the Chairman of the Korea 
Pharmaceutical Traders Association in a form 
of Electronic Data Interchange  in order to go 
through the customs formalities. However, the 
scope of drug s subject to exemption of the 
official approval shall be as provided by the 
‘Regulations for designation of the drugs 
subject to the official approval’ ( Korea Food 
and Drug Administration Notice).   
(2). (Omitted)  Article 4 (Officially Approved Drugs)  (1)— 
-----------------------------------------------------  
--------------------------------- shall go through the 
customs formalities by submitting, in 
accordance with the ‘ Electronic Trade 
Facilitation Act’,  the standards and customs 
clearance probabilities rep ort to the Chairman 
of the Korea Pharmaceutical Traders 
Association in a form of Electronic Data 
Interchange ; and then shall submit an 
application for the official approval to the 
Commissioner of the Korea Food and Drug 
Administration ( hereinafter referred  to as the 
Commissioner of the KFDA) within 3 days 
from the customs clearance.   ---------------------  
------------------------------------------------------  
------------------------------------------------------  
-------------------------------------------- -----------  
------------------------------- . 
(2). (The same as at present ) 
Article 5 (Drugs other than Officially 
Approved Drugs)  (1) Any person importing 
drugs other than officially approved drugs shall 
go through the customs formalities in 
accordance wi th the procedures in the 
following Subparagraphs.  
 1.(Omitted)  
 2. Any person importing pharmaceutical raw 
materials shall submit, pursuant to the 
‘Electronic Trade Facilitation Act’, the 
standards and customs clearance probabilities 
report in a form of Electronic Data Interchange  
to the Chairman of the Korea Pharmaceutical 
Traders Association prior to going through the 
customs formalities.  
<Added a new proviso>  
 
 Article 5 (Drugs other than Officially 
Approved Drugs)  (1)-----------------------------  
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------------------------------ -------------------------  
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 1.( The same as at present ) 
 2.----------------------------------------------------  
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---------- -------------------------------------------- . 
However, if the item to import is a raw 
material stipulated in Article 2 of the ‘ Act on 
the Control of Narcotics, etc.’, the importer Current  Revision  (Proposal) 
 
 
 
 
 3. Any person importing Chinese medicines 
shall submit an application for quality 
inspect ion to the Director of the National 
Institute of Food and Drug Safety Evaluation, 
the Head of Regional Food and Drug 
Administration, or Chinese medicine 
inspection authority  designated by the 
Commissioner of the KFDA; shall take the 
organoleptic inspection  according to the 
imported Chinese medicine test method in 
Appendix 1 prior to going through the customs 
formalities. However, Chinese medicines 
subject to thorough examination and 
examination for harmful substances can go 
through the customs formalities f irst provided 
that the person has submitted a receipt of 
samples to the appropriate customs director.  
 (2) Regardless of the provisions in the 
preceding Paragraph 1 , drugs etc . that fall 
under 1 of the following Subparagraphs are 
exempted from the approval  or inspecti on. 
However, in the case of Subparagraph 6, only 
thorough examination shall be exempted.  
 1.(Omitted)  
 2. Drugs for external diagnosis designated by 
the Minister of the Ministry of Health and 
Welfare.  
 
 3. Items that have submitted a quality 
management test report  certified by the 
government of the country of production and 
then obtained recognition from the head of the 
inspection authority . 
 4.~ 6.(Omitted)  
 7. Chinese medicines for academic, research, 
and study purposes.  
 
 <New>  
 
 
 shall obtain permission from the Commissioner 
of the KFDA, in accordance wit h the Article 
51 of the same Act, in order to go through the 
customs formalities.  
 3.------------------------------------------------------
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------- ------------------------------------------------  
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the head of the quality inspection authority -- 
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------------------------ -------------------------------  
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------------------------------------------ . 
(2)--------- --------------  preceding Paragraph 1,  
------------------------------------ any one  -----------  
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-------------------------------------------------- ----- 
----------------- . 
1. (The same as at present ) 
2. Among the reagents for The Automated 
Biochemical Analyzer, the reagents for use of 
diagnose HIV, HBV, HCV and HTLV.  
3.--------------------------------------------------  
--------- inspection report -----------------------  
-----------------------------------------------------  
----------------------------------------- head of the 
quality inspection authority.  
4.~ 6.(  The same as at present ) 
7. Drugs for academic, research, study and 
clinical trial purposes.  
8. Drugs that passed the conformity 
assessment by evaluating the operation status 
of the production and quality management 
standards in accordance with Article 24 
Paragraph 1 Subparagraph 6 and Article 26 
Paragraph 2 of the ‘ Enforcement Regulations Current  Revision  (Proposal) 
 
(3) The Di rector of the National Institute of 
Food and Drug Safety Evaluation, the Head of 
Regional Food and Drug Administration, the 
Director of the Research Institute of Public 
Health and Environment of the relevant city or 
province or the head of the Chinese medi cines 
inspection authority  designated by the 
Commissioner of the KFDA ( hereinafter 
referred to as “the head of the approval 
authority”), who has received applications, 
according to the provision in the preceding 
Paragraph 1 , shall issue receipts of approva l or 
inspection request.  of the Pharmaceutical Affairs Act’ .  
(3)-----------------------------------------------------
----------------------------------------------------  
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------- -----------------------------------------------  
--------------------- Chinese medicines quality  
inspection authority  -----------------------------  
------------------------------------------------------  
------------------------------------------------------  
------------------------------------------------------  
--according to the preceding Paragraph 1, ---- 
------------------------------------------------------  
-------------------------- . 
Article 6 (Sealing and Stamping etc.)  (1) The 
Director of the National Institute of Food and 
Drug Safety Evaluation , the Director of the 
Research Institute of Public Health and 
Environment of relevant city or province who 
is responsible for the approval or inspection of 
the drugs etc. (excluding Chinese medicines), 
pursuant t o the provisions stipulated in Article 
4 and 5, shall let the official directly collect the 
samples for inspection at the importer’s 
warehouse. The rest of the products shall be 
sealed and stamped.  
(2) The official of the National Institute of 
Food and Dru g Safety Evaluation, the Regional 
Food and Drug Administration ( hereinafter 
referred to as “Regional Administration”), or 
organoleptic inspector from the Chinese 
medicine inspection authority designated by 
the Commissioner of the KFDA shall process 
organol eptic inspection against the Chinese 
medicines that need thorough examination and 
examination for harmful substances. The 
official shall take proper amount for sample 
(For deer antlers, take 3 prongs of antlers and 
cut 5cm out from the cut -off side for the  
sample. In the case of non -dried antlers, take 3  
whole prongs for the sample) from Chinese 
medicines that conform to the inspection 
results at a bonded area in the presence of the 
importer. The sample shall be put into a proper 
container or package. If t he medicines are Article 6 (Sealing and Stamping etc.)  (1) 
The Commissioner of the KFDA, the Director 
of the National Institute of Food and Drug 
Safety Evaluation ---------------------------  
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------------------------------- ------------------------  
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-------------------------------- . 
(2)----------------------------------------------------  
----------------------------- --------------------------  
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---------  Chinese medicines quality inspection  
authority --------------------------------------------  
--------------- ----------------------------------------  
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----------------------- --------------------------------  
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-------------------------------------------------------  Current  Revision  (Proposal) 
costly ones etc., the rest may be sealed and 
stamped if necessary. For non -dried antlers, 
put a necessary mark on the bottom of the 
sample at the time of the sampling in order to 
be ensured that it is the same one once it had 
dried.  
(3) Th e official who processed the sampling 
shall issue the receipt to the importer; the 
receipt shall contain the name of the product, 
importer’s business name, importer and 
country of origin, applied quantity for 
inspection, sampling date and location, amount 
of the sample and the name of the official.  
 <Added a new proviso>  
 
 
 
(4) (Omitted)  -------------------------------------------------------  
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------------ . 
(3) ------------- ---------------------------------------  
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--------------------- . 
In addition, the organoleptic inspectors shall, 
pursuant to the Paragraph 2, seal and stamp the 
samples taken and pass them to the Chinese 
medicines quality inspection a uthority.  
(4) (The same as at present ) 
Article 7 (Notice of the Inspection Result) (1) 
The head of the approval authority  shall, unless 
otherwise regulated,  judge whether the quality 
is proper or not by testing the quality of 
imported drugs etc. that were  submitted for 
approval according to the standards and the 
testing methods for imported items permit, and 
immediately notify the applicant of the result 
(Test report).  
(2) The Commissioner of the KFDA, the head 
of Regional Administration and the head of th e 
inspection authority  shall notify the Chairman 
of the Korea Pharmaceutical Traders 
Association and the importer the results of the 
Chinese medicine quality inspection. The 
certificate of completion of inspection may be 
issued upon request of the importer  if the 
results conform to the guidelines.  Article 7 (Notice of the Inspection Result)(1)  
The Commissioner of the KFDA, and the head 
of the approval authority  --------------------------
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----------------------- --------------------------------  
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(Inspection report).  
(2) The Director of the National I nstitute of 
Food and Drug Safety Evaluation, the head of 
the Regional Administration and the head of 
the Chinese medicines quality inspection 
authority ----------------------------------------------
---------------------------------------------------------
---------------------------------------------------------
---------------------------------------------------------
---------------------------- . 
Article 8 (Reporting Authorization Results)  
The Director of the Research Institute of Public 
Health and Environme nt of the relevant city or 
province and the head of inspection authority  
shall report to the Commissioner of the KFDA 
the results of quality inspections, as stipulated 
in the provisions in Article 5 , by the 10th of the 
next month of every half year end.  Article 8 (Reporting Authorization Results)  
---------------------------------------------------------
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------- Chinese medicines quality inspection 
authority ----------------------------------------------
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------------- in accordance with Article 5 , --------
--------------------------------- . 
Article 9 (Measures concerning the non - Article 9 (Notice for the non -conforming Current  Revision  (Proposal) 
conforming items)  The director of the 
National Institute of Food and Drug Safety 
Evaluation, the head of the Regional 
Administration, the Director of the Research 
Institute of Public Health and Environment of 
the relevant city or province and the head of 
the inspection authority shall, if there are non -
conforming items after the  quality inspection 
in accordance with the provisions stipulated in 
Articles 4, 5, and 7, notify immediately the 
head of the Regional Administration and the 
director of the customhouse of the importer’s 
jurisdiction with a copy of the test report. In 
the c ase of Chinese medicines, the head of the 
other Chinese medicines inspection authorities 
shall be notified as well.  items)  The Commissioner of the KFDA and 
the head of the approval authority shall, if there 
are non -conforming items after the inspection 
in accordance with the provisions stipulated in 
Articles 4, 5, and 7, notify immediately the 
head of the Regional Administration, the 
director of the customhouse of the importer’s 
jurisdiction and the importer with a copy of the 
inspection report. However, in the case of 
Chinese medicines, the head of the other 
Chinese medicines quality inspection 
authorities shall be notified as well.  
Article 10 (Endangered Species) (1)  Any 
person who imported bear’s gall or musk, in  
accordance with Article 43 of the 
‘Pharmaceutical Affairs Act’, shall attach the 
import certificate mark issued by the Chairman 
of the Korea Pharmaceutical Traders 
Association according to the form specified in 
Appendix 2 per sales unit in order to sell t he 
products.  
<New>  
 
 
 
 
 
 
 
 
(2) (Omitted)  Article 10 (Management of Endangered 
Species)  (1) Any person who has intended to 
sell imported bear’s gall or musk, in 
accordance with Article 43 of the 
‘Pharmaceutical Affairs Act’, shall attach the 
CITES certifica te mark issued by the 
Commissioner of the KFDA per sales unit.  
 
 
(2) Any person who intends to attach the 
CITES certificate mark pursuant to the 
preceding Paragraph 1 shall submit an 
application of the attached Form 1 to the  
Commissioner of the KFDA; the 
Commissioner of the KFDA shall verify the 
application and, if the application is suitable , 
shall issue the CITES certificate mark specified 
in Appendix 2.  
(2) (The same as at present)  
Article 11 (The Obligations for the Head of 
the Inspection Authority  etc.)  
(Omitted)  Article 11 (The Obligations for the Head of 
the Quality Inspection Authority  etc.)   
(The same as at present ) 
Article 12 (Revoke the Designation of the 
Inspection Authority  etc.)   
(Omitted)  Article 12 (Revoke the Designation of the 
Quality I nspection Authority  etc.)   
(The same as at present ) 
<New>  Article 13 (Review Period)  Pursuant to 
‘Regulations for the issuance and management 
of directives, established rules etc.’  
(Presidential Directive No.248), the review Current  Revision  (Proposal) 
period for taking necessary me asures such as to 
abolish or revise this notice after the Act and 
subordinate statute or changes in actual 
circumstances etc. has been considered shall be 
until June 29th, 2012.  
[Appendix 1]  
 
Imported Chinese Medicines Testing Method 
(related to Article 5 ) 
 
1. The kinds of and the subject to the test  
 
A. Thorough examination and its subjects  
The thorough examination is an examination 
that follows the standards and methods 
specified in the Korean Pharmacopoeia and 
External Korean Pharmacopoeia for Chinese 
medicines (Herb medicines), and targets the 
following items.  
1. ~ 274. (Omitted)  
<New>  
B. An examination to check for heavy metals, 
pesticide residues, sulphur  dioxide  residues 
and mycotoxins etc. , and targets the following 
Chinese medicines.  
 (1) ~ (4) (Omitt ed) 
<New>  
 
 
 
C. The organoleptic inspection and its subjects  
An organoleptic inspection is a method to 
judge whether it is proper or not by putting 
together the origin, physical aspects (shape, 
colour , taste and smell), foreign substances, 
dryness and pack aging conditions; all Chinese 
medicines listed on the Korean Pharmacopoeia 
and External Korean Pharmacopoeia for 
Chinese medicines (Herb medicines), and 
existing Chinese medical books  that were 
authorized by the Minister of the Ministry for 
Health and Welf are. 
2. Inspection authorities  
 A. Inspection authorities for imported Chinese 
medicines  [Appendix 1]  
 
Imported Chinese Medicines Testing Method 
(related to Article 5)  
 
1. The kinds of and the subject to the test  
 
 A.-----------------------------------------------------
---------------------------------------------------------
---------------------------------------------------------
---------------------------------------- -----------------
---------------------------------------------------------
---------------------------------------------------------
--------------------- . 
1. ~ 274. ( The same as at present ) 
275. talc  
B.------------------------------------------------------
---------------------------------------------------------  
mycotoxins, benzopyrene etc. , -------------------
-------------------- . 
 (1) ~ (4) ( The same as at present ) 
 (5) Benzopyrene test shall be applied to 
Chinese medicines that have been stipulated in 
‘The a cceptable amounts and test methods of  
benzopyrene in herb medicines’.  
C.------------------------------------------------------
---------------------------------------------------------
---------------------------------------------------------
---------------- -----------------------------------------
---------------------------------------------------------
---------------------------------------------------------
---------------------------------------------------------
-------------------------------------------- -------------
---------------------------------------------------------  
existing Chinese medicine books  ----------------
------------  the Minister of the Ministry for 
Health, Welfare and Family Affairs.  
2. Inspection authorities  
 A. Inspection authorities fo r imported Chinese 
medicines  Current  Revision  (Proposal) 
(1) ~ (2) (Omitted)  
(3) Other inspection authorities for Chinese 
medicines designated by the Commissioner of 
the KFDA (manufacturers of Chinese 
medicines are only for harmful substances 
inspections).  
B. (Omitted)  
3. Subject Chinese medicines by an inspection 
authority  
A. (Omitted)  
B. Other inspection authorities  for Chinese 
medicines designated by the Commissioner of 
the KFDA.  
All Chinese medicines including the ones f or 
KFDA.  
4. Test methods  
A.(Omitted)  
B. Inspection for the harmful substances shall 
be processed complying with the following 
standards and methods.  
 (1) ~ (4) (Omitted)  
<New>  
 
C. The organoleptic inspection shall be done 
before the customs clearance as fo llows.  
The inspection shall be performed by an 
official from the National Institute of Food and 
Drug Safety Evaluation, Regional 
Administration or Chinese medicines 
inspection authority  and more than two 
organoleptic inspectors at the bonded area etc. 
prior to the customs clearance.  
D. Conduct the inspection  
 (Omitted)  
 
Equipments required for imported Chinese 
medicines inspection (related to Paragraph 2 
Subparagraph B Item (1) ) (1) ~ (2) ( The same as at present ) 
(3) ---- quality inspection authorities for 
Chinese medicines ----------------------------------
------------  (importers and manufacturers of 
Chinese medicines are excluded).  
 
B. (The same as at  present )  
3. Subject Chinese medicines by an inspection 
authority  
A. (The same as at present ) 
B. ---- quality inspection authorities --------------
---------------------------------------------------------
------------------ . 
All Chinese medicines including the ones in 
Item A above.  
4. Test methods  
A.( The same as at present ) 
B. -----------------------------------------------------
---------------------------------------------------------
---------------------------- . 
 (1) ~ (4) ( The same as at present ) 
 (5) Th e acceptable amounts and test methods 
of benzopyrene in herb medicines  
C.------------------------------------------------------
---------------------------------------------------------
---------------------------------------------------------
--------------- ------------------------------------------
---------------------------------------------------------
--------------------  Chinese medicines quality 
inspection authority  --------------------------------
---------------------------------------------------------
------------------------------- . 
D. Notify the inspection results  
 (The same as at present ) 
 
Equipments required for imported Chinese 
medicines inspection (related to Subparagraph 
2 Item B (1)  
  
 
[Appendix 2] Import certificate mark (related 
to Article 10 ) 
  [Appendix 2] CITES certificate mark (related 
to Article 10)  
 Current  Revision  (Proposal) 
 
 
  
 
  
[Attachment]  
 
[Attached Form1]                                                                                          
(front)  
Processing Per iod Application for CITES Certificate Mark  
Immediate  
Business Name   Representative   
Location   Applicant  
Person in Charge   Contact Number  Phone:  
Fax: 
Item Name   Musk           Bear’s Gall  
Quantity   Packing Unit   Application 
Details  Number of 
Stamps     
 
    
 I hereby apply for issuance of the CITES Certificate Mark in accordance with provisions of Article 10 of the 
‘Management Regulations of Imported Drugs, etc.’.  
 
 
 
 
                                                                             Date:   
 
 
 
 
 
                                                                     Applicant:                                              ( signing or sealing)  
 
 
 
 
 
(To) The Commissioner o f the Korea Food and Drug Administration  
 
 
Fee 
Required Documents: None  
None  
 210mm×297mm ( Newsprint paper 54 g/ m2)  
* This application will be processed as below.  
                                                                                                                                            (back)  Receive Application
Examine
Approve
the Application
Issue StampsFill the ApplicationApplicantProcessing Authority
Korea Food and Drug AdministrationIntermediate
Body
Relevant
City/Province
Deliver the Stamps