. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/SLV/154 
1 July 2011 
 (11-3231) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
 
NOTIFICATION 
 
The following notification is being circ ulated 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:   Consejo Nacional de Ciencia y Tecnología , CONACYT (National 
Science and Technology Council) 
Name and address (including telephone  and fax numbers, 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:  
Colonia Medica, Avenida Dr Emilio Alvarez 
Pasaje Dr Guillermo Rodriguez Pacas, N° 51 San Salvador, El Salvador Tel.:  + (503) 22 348 411 
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):   Pharmaceutical products 
(International Classification for St andards (ICS) c ode 11.120.01) 
5. Title, number of pages and language(s) of the notified document:   RTCA 11.03.59:11, 
Productos Farmacéuticos.  Medicamentos de  uso humano.  Requisitos de Registro 
Sanitario (Central American Technical Regulation (RTCA) No. 11.03.59:11:  
Pharmaceutical products.  Medicines for human use.  Sanitary registration requirements) 
(26 pages, in Spanish) 
6. Description of content:   The notified Technical Regula tion establishes the conditions and 
requirements for the sanitary registration of medicines for human use.  It applies to medicines for human use that are manufactured or imported by natural or legal persons for 
marketing in the Central American region.   The Regulation does not cover magistral 
preparations.  Biological and biotechnological medicines shall be registered in accordance with the domestic legislation of each State Party.  Where a State Party does not have domestic legislation on the registration of bi ological and biotechnological medicines, the 
notified Regulation shall be  applied to these products. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health G/TBT/N/SLV/154 
Page 2  
 
  8. Relevant documents:  
(a)  Central American Technical Regulation (RTCA) No. 11.03.39:06:  Productos 
Farmacéuticos.  Reglamento de Validación de Métodos Analíticos para la Evaluación 
de la Calidad de los Medicamentos  (Pharmaceutical products.  Regulations on the 
validation of analytical methods for assessing the quality of medicines); 
(b)  RTCA No. 11.01.02:04:  Productos Farmacéuticos.  Etiquetado de Productos 
Farmacéuticos para Uso Humano  (Pharmaceutical products.  Labelling of 
pharmaceutical products for human use); 
(c)  RTCA No. 11.01.04:05:  Productos Farmacéuticos.  Estudios de Estabilidad de 
Medicamentos para Uso Humano  (Pharmaceutical products.  Stability studies on 
medicines for human use); 
(d)  RTCA No. 11.03.47:07:  Productos Farmacéuticos.  Medicamentos para Uso 
Humano.  Verificación de la Calidad  (Pharmaceutical products.  Medicines for human 
use.  Quality verification); 
(e)  RTCA, Buenas  Prácticas de Manufactura de  la Industria Farmacéutica  (Good 
manufacturing practices for the pharmaceu tical industry) (COMIECO Resolution 
No. 93-2002, Annex 3); 
(f)  RTCA No. 11.03.42:07:  Productos Farmacéuticos.  Medi camentos de Uso Humano.  
Buenas Prácticas de Manufactura  para la Industria Farmacéutica  (Pharmaceutical 
products.  Medicines for human use.  Good manufacturing practices for the pharmaceutical industry).
  
9. Proposed date of adoption: 
Proposed date of entry into force:   Date of publication in the Official Journal 
Six months after publication in the Official 
Journal 
10. Final date for comments:   60 days from the date of notification 
11. Texts available from:  National enquiry  point [X] or address, telephone and fax 
numbers, e-mail and website addresses,  if available of the other body: 
Dirección de Administración de Tratados Comerciales 
Alameda Juan Pablo II y Calle Guadalupe Plan Maestro San Salvador, El Salvador Tel.: (503) 2247-5788 Fax: (503) 2247-5789 
E-mail: ezelada@minec.gob.sv  
Consejo Nacional de Ciencia y Tecnología (CONACYT) 
Colonia Médica, Avenida Dr Emilio Álvarez Pasaje Dr Guillermo Rodríguez Pacas, N° 51 San Salvador, El Salvador 
Tel.: (503) 2234-8416 
Fax: (503) 2225-6255 Website: http://www.infoq.org.sv/  
E-mail: evanegas@conacyt.gob.sv