. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/SLV/129 
5 May 2009 
 (09-2179) 
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:  
Colonia Medica 
Avenida Dr Emilio Álvarez y Pasaje Dr Guillermo Rodriguez Pacas N° 51 San Salvador, El Salvador, Central America 
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 
(HS Chapter 30;  International Classifica tion for Standards (ICS) code 11.120.99) 
5. Title, number of pages and language(s) of the notified document:   NSO RTCA 
11.03.56:09, Productos Farmacéuticos.  Productos Naturales Medicinales para Uso 
Humano.  Verificación de la Calidad (Salvadoran Mandatory Standard (NSO)/Central 
American Technical Regulation (RTCA) No. 11.03.56:09:  Pharmaceutical products.  
Natural medicines for human use.  Qua lity control) (8 pages, in Spanish). 
6. Description of content:   The notified Technical Regulation establishes the analytical tests 
which must be carried out by the regulatory authority to verify the quality of natural medicines for human use.  The provisions of th is Regulation apply to all natural medicines 
for human use which are imported into or ma nufactured in Central American countries.  
The Regulation guidelines are mandatory for all natural medicines the pharmaceutical form 
of which is administered by any route other than ophthalmic or parenteral. 
7. Objective and rationale, including the nature of urgent problems where applicable:  
Prevention of practices likely to mislead the consumer and protection of human health. 
8. Relevant documents:  
• Appendix XVI D, Microbiological quality of pharmaceutical preparations , 
British Pharmacopoeia, Volume IV. 2007; 
• The United States Pharmacopeia 30 and The National Formulary 25.  30th Edition.  The 
United States Pharmacopeial Convention Inc. USA. 2007; G/TBT/N/SLV/129 
Page 2  
 
  • Secretaría de Salud, Comisión Permanente de  la Farmacopea de los Estados Unidos 
Mexicanos  (Ministry of Health, Permanent Pharmacopoeia Commission of the 
United Mexican States), Farmacopea Herbolaria de lo s Estados Unidos Mexicanos  
(Herbal Pharmacopoeia of the United Mexican States).  Mexico.  2001; 
• Arias, Tomas D., Glosario de Medicamentos:  Desarrollo, Evaluación y Uso  (Glossary 
of medicines:  development, evaluation and use), 1
st Edition.  Pan American Health 
Organization, USA. 1999; 
• García G., Mildred, Legislación en Iberoamérica sobre Fitofármacos y Productos 
Naturales  (Ibero-American legislation on phyt omedicines and natural products).  
Ibero-American Programme of Science and Technology for Development (CYTED).  
Costa Rica, 2000; 
• RTCA 67.04.50:08, Alimentos.  Criterios Microbiológicos para la Inocuidad de 
Alimentos  (Central American Technical Regulation (RTCA) No. 67.04.50:08:  Food 
products.  Microbiological criteria for food safety). 
9. Proposed date of adoption: 
Proposed date of entry into force:  Upon publication in the Official Journal 
Six months after publication in the Official 
Journal 
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 addresses, if available, of other body:  
Ministerio de Economía 
Dirección de Administración de Tratados Comerciales Alameda Juan Pablo II y Calle Guadalupe 
Plan Maestro, San Salv ador, El Salvador 
Tel.: (503) 2231-5788 Fax: (503) 2231-5789 E-mail: ezelada@minec.gob.sv
 
or address, telephone and fax numbers and E-ma il and website addresses, if available, of 
other body: 
Consejo Nacional de Ciencia y Tecnología (CONACYT) 
Colonia Médica, Avenida Dr Emilio Alvarez Pasaje Dr Guillermo Rodríguez Pacas, #51 San Salvador, El Salvador Tel.: (503) 2226-2800 
Fax: (503) 2225-6255 
Website: http://www.conacyt.gob.sv/
 
 For further information, please c ontact:  Ms Evelyn de Vanegas 
Tel.: (503) 2234-8411 
E-mail: evanegas@conacyt.gob.sv