WORLD TRADE  
ORGANIZATION  G/SPS/N/CRI/69 
5 December 2008 
 (08-5969) 
Committee on Sanitary a nd Phytosanitary Measures Original:   Spanish 
  
NOTIFICATION  
 
1. Notifying Member:  COSTA RICA
  
If applicable, name of local government involved:   
2. Agency responsible:  Ministerio de Agricultura y Ganadería, Servicio Nacional de Salud 
Animal , SENASA (Ministry of Agriculture and Livestock, National Animal Health 
Service) 
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):  International Classifi cation for Standards (ICS) code 65.020.30 
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:  Reglamento Técnico Centroamericano RTCA 
65.05.51:08 Medicamentos Veterinarios y Productos Afines, Establecimientos.  Registro Sanitario y Control  (Central American Technical Regulation (RTCA) No. 65.05.51:08: 
Veterinary drugs and relate d products and establishments in this sector.  Sanitary 
registration and control). 
Text available at:  http://www.senasa.go.cr/documentosenconsultaOMC.html
 
Full text of notification: 
http://members.wto.org/crnattach ments/2008/sps/CRI/08_3901_00_s.pdf  
Language:  Spanish  Number of pages:  37 
6. Description of content:  The notified Regulation establishes provisions governing the 
sanitary registration and control of vete rinary drugs and re lated products and 
establishments in this sector.  This Re gulation applies to pharmaceutical products, 
alternative veterinary medicines, chemicals exclusively for veterinary use or use in 
livestock facilities, veterinary biologics and an imal hygiene and grooming products, as well 
as to establishments which manufacture, market , fraction or store veterinary 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.  G/SPS/N/CRI/69 
Page 2  
 
  8. Is there a relevant international stan dard?  If so, identify the standard:  
[ X ] Codex Alimentarius Commission (e.g. title or serial number of Codex standard 
or related text)  
[ X ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)  
[   ] International Plant Protection Convention (e.g. ISPM N°)  
[   ] None Does this proposed regulation conform to  the relevant international standard? 
 [ X ] Yes  [   ] No  If no, describe, whenever possible, how and why it deviates from the 
international standard:  
9. Other relevant documents and langua ge(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; 
• Approved documents of the Committee of the Americas for Veterinary Medicines 
(CAMEVET-OIE); 
• 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, La 
Gaceta 
Proposed date of publication ( dd/mm/yy) : 
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 ):  2 February 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:   G/SPS/N/CRI/69 
 Page 3 
 
 
  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 
Servicio Nacional de Salud Animal (SENASA) Centro de Información y Notificación en  Medidas Sanitarias y Fitosanitarias 
Apartado Postal 70-3006 
Barreal de Heredia, Costa Rica Tel.: +(506) 22 60 83 00, ext. 2065 Fax: +(506) 22 62 78 31 E-mail: notificaciones@protecnet.go.cr 
Web site: www.senasa.go.cr