. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/TPKM/152 
13 February 2009 
 (09-0747) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
 
 
 
NOTIFICATION  
 
1. Notifying Member:  THE SEPARATE CUSTOMS TERRITORY OF TAIWAN, 
PENGHU, KINMEN AND MATSU   
If applicable, name of local government involved:    
2. Agency responsible:  Department of Health 
3. Products covered (provide tariff item number(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):  Orally-taken vitamin and mineral products 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[ X ] All trading partners, or [   ] Specific regions or countries:    
5. Title of the notified document:  Draft of Monograph for Vitamin and Mineral 
Pharmaceutical Products Review and Approval  Language:  English  Number of 
pages:  26 
http://members.wto.org/crnattach ments/2009/sps/TPKM/09_0604_00_e.pdf  
http://members.wto.org/crnattach ments/2009/sps/TPKM/09_0604_00_x.pdf  
6. Description of content:  The amendment of this draft is to regulate the daily dosage 
limitation, classification and indications of the vitamin and mineral products made by 
single or complex, orally-taken pharmaceutical form. 
7. Objective and rationale:  [ X ] food safety, [   ] animal health, [   ] plant protection, [  
 ] protect humans from animal/plant pest or disease, [   ] protect territory from other damage from pests.    
8. Is there a relevant international stan dard?  If so, identify the standard:  
[   ] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text)    
[   ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)     
[   ] International Plant Protection Convention (e.g.  ISPM N°)     
[ X ] None G/SPS/N/TPKM/152 
Page 2  
 
   Does this proposed regulation conform to  the relevant international standard?   
 [   ] Yes   [   ] No 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:    
9. Other relevant documents and language (s) in which these are available:  Draft of 
Monograph for Vitamin and Mineral Pharma ceutical Products Review and Approval 
(4 February 2009, Drug No.0980305000) is available in English from the National 
Notification Authority, National Enquiry Point,  and Department of Health.  The standard 
will be published in the Official Government Gazette when adopted.  The full text may be 
downloaded from the following website: http://www.doh.gov.tw/EN2006/DM/D M1.aspx?class_no=247&level_no=1
 
10. Proposed date of adoption (dd/mm/yy) :  To be determined.  
Propose date of publication ( dd/mm/yy) :  To be determined. 
11. Proposed date of entry into force:  [   ] Six months from date of publication , and/or  
(dd/mm/yy) :  To be determined. 
[   ] Trade facilitating measure 
12. Final date for comments: [ X ] Sixty days  from the date of circulation of the 
notification and/or ( dd/mm/yy ):  14 April 2009 
Agency or authority designated to handle comments:  [   ] National Notification 
Authority, [ X ] National Enquiry Point.  Address, fax number and E-mail address (if available) of other body:    
Bureau of Pharmaceutical Affair 
Department of Health No.36, Tacheng St, Datong District, Taipei City 10341, Taiwan Tel:  +(886 2) 8590 6666 ext. 6989 Fax:  +(886 2) 2523 3303 
E-mail:  paamine@doh.gov.tw 
13. Texts available from:  [   ] National Notification Authority, [ X ] National Enquiry 
Point.  Address, fax number and E-mail address (if available) of other body:    
Bureau of Pharmaceutical Affair  
Department of Health No.36, Tacheng St, Datong District, Taipei City 10341, Taiwan 
Tel:  +(886 2) 8590 6666 ext. 6989 
Fax:  +(886 2) 2523 3303 E-mail:  paamine@doh.gov.tw