. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/KOR/71 
15 April 2004  
 
(04-1691) 
Committee on Technical Barriers to Trade Original:  English 
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   REPUBLIC OF KOREA  
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Ministry of Health and Welfare (MOHW) 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:         
3. Notified under Article 2.9.2 [  X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:         
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):   Pharmaceuticals 
5. Title, number of pages and language(s) of the notified document:   Draft Amendment of 
Ministerial Ordinance of the Pharmaceutical Affairs Act (28 pages, in Korean) 
6. Description of content:     
− When applying for approval of biological products, etc., review data to prove its 
safety and efficacy shall be submitted. 
− When applying for approval of generic drugs  in the form of tablets, capsules and 
suppositories that are prescription drugs, the protocol to establish their biological equivalence must be submitted. 
− Subject to the Guidelines on Reporting of Imported Raw Pharmaceutical Materials, 
all expenses for on-site inspection in th e origin countries will be borne by their 
importers. 
− Obligations and observances require d of quality assurance agencies on 
pharmaceuticals, etc., have been reinforced. 
− For pharmaceuticals subject to re-examination to the KFDA, manufacturers (or 
importers) will be required to submit a pr otocol on the clinical experience and 
report on the progress of annual surveillance. 
− Manufacturers and importers will be obligat ed to operate a voluntary recall system 
for defective pharmaceutical products. 
− The Commissioner of the KFDA (Korean Food and Drug Administration) is 
authorized to establish provisions for sp ecial packing of pharmaceuticals so as to 
prevent drug-related accidents caused by children. 
− Manufacturers (or importers) are require d to produce (or import) and supply 
pharmaceuticals in small quantity packagi ngs besides economy-sized ones, as 
provided for by the Commissioner of the KFDA besides economy-sized ones. G/TBT/N/KOR/71 
Page 2  
 
− Legal grounds will be established for ma nufacturers to purchase pharmaceuticals 
produced by other manufacturers for th e purpose of developing new products. 
− For biological substances, the relevant regulations on manufacturing and marketing 
shall be separately specified. 
− Pharmaceuticals wholesalers and retailers are obligated to report any unauthorized 
or illegal products that they become aware of.  However, when they are manifestly 
found to be irrelevant to the obligations , legal punishment will be relieved or 
exempted by the regulation. 
− The provision allowing pharmaceutical wholesal ers, at the initial stage of separation 
policy between prescribing and dispensi ng, to sell pharmaceuticals in open 
packagings has been deleted. 
− For pharmaceuticals separately designated by the Commissioner of the KFDA, the 
name of additives shall be clearly wr itten on the external packets by the 
manufacturers, and additional regulations  will be added hereto as necessary.  
− Detailed provisions will be established fo r using electronic money to pay for 
drug-related service charges. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Improving national health 
8. Relevant documents:   MOHW notification 2004-68(Available in Korean only) 
9. Proposed date of adoption:   
Proposed date of entry into force:   }July 2004 
10. Final date for comments:   3 June 2004 
11. Texts available from:  National enquiry point [    ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
Documents are available from the Ministry of Health and Welfare website 
(www.mohw.go.kr ).  Also available from:  
 Trade Affairs Division 
 Ministry of Health and Welfare  1, Joongang-dong Kwancheon, Kyunggi 
 427-721, Republic of Korea  
 Tel: +82 2 2110 6458  Fax: +82 2 504 3981  E-mail:  ykjeong@mohw.go.kr