. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/GTM/45 
5 January 2009 
 (09-0001) 
Committee on Sanitary a nd Phytosanitary Measures Original:   Spanish 
  
 
NOTIFICATION 
 
1. Notifying Member:   GUATEMALA
 
If applicable, name of local government involved: 
2. Agency responsible:  Ministerio de Agricultura y Ganadería  (Ministry of Agriculture and 
Livestock) 
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):  ICS code 65.020.30 
4. Regions or countries likely to be affect ed, to the extent relevant or practicable:
 
[ X ] All trading partners, or 
[   ] Specific regions or countries: 
5. Title of the notified document:  RTCA 65.05.51:08 Medicamentos Veterinarios y 
Productos Afines, Establecimientos que los Fabrican, Comercializan, Fraccionan o 
Almacenan.   Requisitos de Registro Sanitario y Control  (Central American Technical 
Regulation (RTCA) No. 65.05.51:08:  Vete rinary drugs and related products, and 
establishments engaged in the manufacture, ma rketing, fractioning or storage thereof.  
Sanitary registration and control requirements).  Language:  Spanish Number of 
pages:  37 
6. Description of content:  The aim of the notified Regulation is to establish provisions 
governing the sanitary registration and control of  veterinary drugs a nd related products and 
establishments in this sector.  The Regul ation applies to pharmaceutical products, 
alternative medicines, chemical s exclusively for veterinary use or use in livestock facilities, 
veterinary biologics and animal hygiene and grooming products, as well as to 
establishments which manufacture, market, frac tion or store veterina ry drugs and related 
products in Central American countries. 
7. Objective and rationale:  [ X ] food safety, [ X ] animal health, [   ] plant protection, 
[ X ] 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)  G/SPS/N/GTM/45 
Page 2  
 
  8. Is there a relevant international standa rd?  If so, identify the standard:   (cont'd) 
[   ] International Plant Protection Convention (e.g. ISPM N°)  
[ X ] None  
Does this proposed regulation conform to  the relevant international standard? 
 [   ] Yes   [ X ] 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: 
• Code of Federal Regulations (CFR) of  the Food and Drug Administration (FDA), 
Titles 9 and 21, United States of America; 
• International Programme on Chemical  Safety (IPCS), World Health 
Organization (WHO); 
• Codex Alimentarius Commission:  Maximum Residue Limits (MRLs) approved for 
veterinary drugs and pesticides; 
• European Medicines Agency (EMEA):  Maximum Residue Limits (MRLs) approved 
for veterinary drugs and pesticides; 
• United States Pharmacopoeia; 
• European Pharmacopoeia. 
10. Proposed date of adoption (dd/mm/yy) :  Upon publication in the Official Journal. 
Proposed date of publication (dd/mm/yy) : 
11. Proposed date of entry into force (dd/mm/yy) :  [   ] 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) :  6 March  2009 
Agency or authority designated to handle comments:  [ X ] National Notification 
Authority, [   ] National Enquiry Point.   Address, fax number and e-mail address (if 
available) of other body:  
13. Texts available from:  [ X ] National Notification Authority, [ X ] National Enquiry 
Point.  Address, fax number and e-mail address (if available) of other body: 
Ministerio de Agricultura y Ganadería 
Centro de Normas y Procedimientos Jorge Gómez Guatemala 
Tel.:  +(502) 2413 7000 
E-mail:  jgomez@maga.gob.gt