G/SPS/N/SLV/123  
23 August 2016  
(16-4488) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original:  Spanish  
 
  NOTIFICATION  
1. Notifying Member : EL SALVADOR  
If applicable, name of local government involved:  
2. Agency responsible : Organismo Salvadoreño de Reglamentación Técnica , OSARTEC 
(Salvadorian Technical Regulation Agency)  
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 number : 11.120.01  
4. Regions or countries likely to be affected, to the extent relevant or practicable:  
[X] All trading partners  
[ ] Specific regions or countries:  
5. Title of the notified document : RTS 11.02.02:16 Productos Farmacéuticos . 
Medicamentos para Uso Humano . Farmacovigilancia  (Salvadorian Technical Regulation 
(RTS) No. 11.02.02:16 : Pharmaceutical product s. Medicines for human use . 
Pharmacovigilance) Language(s) : Spanis h Number of pages : 15 
http://members.wto.org/crnattachments/2016/SPS/SLV/16_3447_00_s.pdf  
6. Description o f content : The notified text sets out guidelines for the detection, 
quantification, evaluation, analysis and prevention of adverse reactions to medicines, 
events supposedly attributed to vaccines and immunization, and other problems relating to 
medicines f or human use.  
7. Objective and rationale : [ ] food safety, [ ] 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 standard ? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g. title or serial number of Codex 
standard or related text)  
[ ] World Organisation for Animal Health (OIE) (e.g. T errestrial or Aquatic 
Animal Health Code, chapter number)  
[ ] Internation al Plant Protection Convention ( e.g. I SPM No. ) 
[X] None  
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:   G/SPS/N/SLV/123  
- 2 - 
  9. Other rel evant documents and language(s) in which these are available:  
 Bases Legales para la Farmacovigilancia en Chile  (Legal Framework for 
Pharmacovigilance in Chile), Chile, 2012.  
 Buenas Prácticas de Farmacovigilancia del Sistema Español de Farmacovigilancia de 
Medicamentos de Uso Humano  (Good Pharmacovigilance Practices - Spanish 
Pharmacovigilance System for Medicines for Human Use), Spain, 2002.  
 Good Pharmacovigilance Practices for the Americas , Pan American Network on Drug 
Regulatory Harmonization (PANDRH), 20 10. 
 Manual de Reglamentos, Procedimientos y Buenas Prácticas de Farmacovigilancia del 
Paraguay  (Paraguayan Handbook of Pharmacovigilance Regulations, Procedures and 
Good Practices), Paraguay, 2011.  
 Mexican Official Standard NOM -220-SSA1 -2012: Instalación y  Operación de la 
Farmacovigilancia  (Establishment and Functioning of P harmacovigilance), Mexico, 
2012.  
 Reglamento para el funcionamiento del Sistema de Farmacovigilancia  (SNFV), 
(Regulation on the Operation of the Pharmacovigilance System), Ecuador, 2013.  
10. Proposed date of adoption (dd/mm/yy) : August 2 016 
Proposed date of publication (dd/mm/yy) : August 2 016 
11. Proposed date of entry into force : [ ] Six months from date of publication, and/or 
(dd/mm/yy) : August 2 016 
[ ] Trade facilitating measure  
12. Final date for comments : [ ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable.  
Agency or authority designated to handle comments : [ ] National Notification 
Authority, [ ] National Enquiry Point . Address, fax n umber and email address (if 
available) of other body:   
13. Text(s) available from : [X] National Notification Authority, [ ] National Enquiry 
Point . Address, fax number and email address (if available) of other body:  
Ministerio de Economía  
Dirección de Adm inistración de Tratados Comerciales  
Alameda Juan Pablo II y Calle Guadalupe, Plan Maestro, San Salvador, El Salvador  
Tel.:  (+503) 2590 5788  
Fax:  (+503) 2590 5789  
Email:  datco@minec.gob.sv  
Website:  http://www.minec.g ob.sv/  
 
Organismo Salvadoreño de Reglamentación Técnica  (OSARTEC ) 
1ª Calle Poniente y Final 41 Av . Norte, N° 18, Colonia Flor Blanca  
San Salvador, El Salvador  
Tel.:   (+503) 2590 5323  
   (+503) 2590 5335  
Email : consultasreglamento@osartec.gob.sv  
Website:  http://www.osartec.gob.sv/