G/TBT/N/SLV/167  
14 August 2013  
(13-4360)  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 governme nt involved (Articles 3.2 and 7.2):  
2. Agency responsible:  Organismo Salvadoreño de Reglamentación Técnica, OSARTEC 
(Salvadorian Technical Regulation Agency) 
Name and address (including telephone and fax numbers and e-mail and website 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be indicated 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 Salvador Tel.: (+503) 2590-5788 
Fax: (+503) 2590-5789 
E-mail: datco@minec.gob.sv ; jmilla@minec.gob.sv  
Website: http://www.minec.gob.sv  
3. Notified under Arti cle 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], other:   
4. Products covered (HS or CCCN where app licable, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):  International 
Classification for Standards (ICS) code 11.120.99 
5. Title, number of pages and language(s) of the notified document:  RTCA 11.03.69:13, 
Productos Farmacéuticos. Productos Naturales Medicinales de Uso Humano. Buenas Prácticas 
de Manufactura (Central American Technical Regulation (RTCA) No. 11.03.69:13: 
Pharmaceutical products. Natural medicines for human use. Good Manufacturing Practices) (51 pages, in Spanish).  
6. Description of content:  The notified Technical Regulation establishes the principles 
and guidelines set forth in the Good Manufacturing Practices that regulate all procedures 
involved in the manufacture of natural medicines for human use, in order to assure 
the efficacy, safety and quality of such products. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health. G/TBT/N/SLV/167 
- 2 - 
  8. Relevant documents:  
- Proyecto de RTCA Reglamento Técnico Centroamericano de Productos Farmacéuticos. 
Medicamentos de Uso Humano. Buenas Prácticas de Manufactura para la Industria 
Farmacéutica  (Draft Central American Technical Regulation on pharmaceutical products. 
Medicines for human use. Good manufacturing practices for the pharmaceutical industry). 
- WHO guidelines on good manufacturing practices (GMP) for herbal medicines, 2007.  
9. Proposed date of adoption: 
Proposed date of entry into force:   To be determined. 
To be determined. 
10. Final date for comments:  60 days as from the date of notification. 
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and e-mail and website addresse s, if available, of other body: 
Ministerio de Economía 
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 
E-mail: datco@minec.gob.sv ; jmilla@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) 2590-5331; (+503) 2590-5335 
E-mail: consultasreglamento@osartec.gob.sv  
Website: http://www.osartec.gob.sv