G/TBT/N/SLV/184  
25 August 2016  
(16-4518) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member : EL SALVADOR  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible : Organismo Salvadoreño de Reglame ntación Técnica , OSARTEC 
(Salvadorian Technical Regulation Agency)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be in dicated if different from above:  
Ministerio de Economía  (Ministry of the Economy)  
Dirección de Administración de Tratados Comerciales  (Directorate of Trade Treaty 
Administration)  
Alameda Juan Pablo II y Calle Guadalupe, Plan Maestro, San Salvador, El Salva dor 
Tel.: (+503) 2590 5788  
Fax: (+503) 2590 5789  
Email: datco@minec.gob.sv  
Website: http://www.minec.gob.sv/   
3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7. 1 [ ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading . ICS numbers may be provided in addition, where applicable) : 11.120.01  
5. Title, number of pages and language(s) of the notified document : RTS 11.02.02:16 
Productos farmacéuticos . Medicamentos para uso humano . Farmacovigilancia  (Salvadorian 
Technical Regulation (RTS) 11.02.02:16 : Pharmaceutical products . Medicines for human 
use. Pharmacovigilance) (15 pages, in Spanish)  
6. Description of content : The notifie d 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 for human use.  
7. Obje ctive and rationale, including the nature of urgent problems where 
applicable : Prevention of adverse reactions to medicines, events supposedly attributed to 
vaccines and immunization, and other problems relating to medicines for human use.  
8. Relevant doc uments:  
 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 Pra ctices - Spanish 
Pharmacovigilance System for Medicines for Human Use), Spain, 2002.  
 Good Pharmacovigilance Practices for the Americas, Pan American Network on Drug G/TBT/N/SLV/184  
- 2 - 
  Regulatory Harmonization (PANDRH), 2010.  
 Manual de Reglamentos, Procedimientos y Buenas Prá cticas 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 Pharmacovigilance), Mexico, 
2012.  
 Reglamento para el funcionamiento del Sistema de Farmacovigilancia  (SNFV) 
(Regulation on the Operation of the Pharmacovigilance System), Ecuador, 2013.  
9. Proposed date of adoption : August 2 016 
Proposed dat e of entry into force : August 2 016 
10. Final date for comments : Not applicable.  
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Ministerio de Economí a 
Dirección de Administración 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.gob.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/  
https://members.wto.org/crnattachments/2016/TBT/SLV/16_3446_00_s.pdf