. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/SLV/85 
11 November 2008 
 (08-5445) 
Committee on Sanitary a nd Phytosanitary Measures Original:   Spanish 
  
 
NOTIFICATION 
 
1. Member to Agreement notifying:  EL SALVADOR
 
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):  Pharmaceutical products: HS Chapter 30 (International Classification for 
Standards (ICS) code 65.020.30)  
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
 Trading partners  
5. Title, language and number of pages of the notified document:  NSO RTCA 
65.05.51:08: Medicamentos Veterinarios y Productos Afines, Establecimientos que los Fabrican, Comercializan, Fraccionan o Almace nan.  Requisitos de Registro Sanitario y 
Control  (Salvadoran Mandatory Standard (NSO) / Central American Technical Regulation 
(RTCA) No. 65.05.51:08: Veterinary drugs and related products, and establishments 
engaged in the manufacture, marketing, fractioni ng or storage thereof.  Sanitary registration 
and control requirements) (37 pages, in Spanish).  
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. This Regula tion applies to pharmaceutical products, 
alternative medicine products, chemicals exclus ively 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 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 
8. International standard, guideline or recommendation: 
[ X ] Codex Alimentarius Commission,  [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention,  [ X ] None 
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:  This Standard adopts Commission Regulation 
(EC) No 1881/2006 and Commission Regulation (EC) No 333/2007. G/SPS/N/SLV/85 
Page 2  
 
  9. 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:  Upon publication in the Official Journal  
11. Proposed date of entry into force:  Six months as from the date of adoption  
12. Final date for comments:  Sixty (60) days as from the date of this notification 
Agency or authority designated to handle comments:  [  X ] National notification 
authority, [    ] National enquiry point, or a ddress, fax number and E-mail address 
(if available) of other body: 
13. Texts available from:  [  X ] National notification authority, [  X ] National enquiry 
point, or address, fax number and E-mail address (if available) of other body:  
Ministerio de Economía 
Dirección de Administración de Tratados Comerciales Alameda Juan Pablo II y Calle Guadalupe 
Plan Maestro, San Salv ador, El Salvador 
Tel.: (+503) 2231-5788 Fax: (+503) 2231-5789 E-mail: ezelada@minec.gob.sv 
Consejo Nacional de Ciencia y Tecnología, CONACYT 
Colonia Médica, Avenida Dr. Emilio Alvarez 
Pasaje Dr. Guillermo Rodríguez Pacas, No. 51 
San Salvador, El Salvador Tel.:   (503) 2226-2800 Fax:   (503) 2225-6255 Web site:  http://www.infoq.gob.sv/