. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/SLV/99 
9 October 2006 
 (06-4827) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:  EL SALVADOR
 
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:   Consejo Nacional de Ciencia y Tecnología  - CONACYT (National 
Science and Technology Council) 
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) 2231-5788 Fax:  (+503) 2231-5789 
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 applic able, otherwise national tariff heading.  
ICS numbers may be provided in addition, where applicable):   Good Manufacturing 
Practices for the Pharmaceutical Industry (International Classification for Standards (ICS) code 11.120.99). 
5. Title, number of pages and language(s) of the notified document:   RTCA 11.04.42:06 
Productos Farmacéuticos.  Medicamentos de  Uso Humano.  Buenas Prácticas de 
Manufactura para la Industria Farmacéutica  (Central American Technical Regulation 
(RTCA) No. 11.04.42:06:  Pharmaceutical products.  Medicines for Human Use.  Good Manufacturing Practices for the Pharmaceutical Industry) (69 pages, in Spanish). 
6. Description of content:   This Technical Regulation establishes the principles and 
guidelines set forth in the Good Manufacturing Practices that regulate all procedures involved in the manufacture of pharmaceutical products, in order to assure the efficacy, safety and quality of such products. 
 It applies to laboratories manufacturing pharmaceutical products in Central 
American countries. G/TBT/N/SLV/99 
Page 2  
 
  7. Objective and rationale, including the nature of urgent problems where applicable: 
 Protection of human health and life. 
8. Relevant documents: 
Thirty-Second Report. Technical repor t series 823, WHO Expert Committee on 
Specifications for Pharmaceutical Preparations, Geneva 1992. 
Guía de inspección y auto inspección de Bu enas Practicas de Manufactura para la 
Industria Farmacéutica  (Guidelines for the inspection and self-inspection of Good 
Manufacturing Practices for the Pharmaceutical Industry) in Central American countries. 
9. Proposed date of adoption:  
Proposed date of entry into force:   Upon publication in the Official Journal 
Six months as from the date of adoption 
10. Final date for comments:   60 days as from the date of notification 
11. Texts available from:  National enquiry point [  ], or address, telephone and fax 
numbers and E-mail and Website addresses, if available, of other body:  
Ministerio de Economía 
Dirección de Administración de Tratados Comerciales Edificio C-2  Tercer Nivel Alameda Juan Pablo II y Calle Guadalupe Plan Maestro 
San Salvador 
El Salvador E-mail:  ezelada@minec.gob.sv Tel.:  +(503) 2231-5788 Fax:  +(503) 2231-5789 
Consejo Nacional de Ciencia y Tecnología (CONACYT) 
Colonia Médica Avenida Dr Emilio Alvarez pasaje Dr Guillermo Rodríguez Pacas, #51 Tel.:  +(503) 2226-2800; (503) 2235-4191 Fax:  +(503) 2225-6255 
E-mail:   guerrero@conacyt.gob.sv 
Web site: www.infog.gov.sv