. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/SLV/160 
13 February 2012 
 (12-0833) 
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:   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 Co merciales (Directorate of Trade Treaty 
Administration) Alameda Juan Pablo II y Calle Guadalupe Plan Maestro, San Salvador 
Tel.: (+503) 2247-5788 
Fax: (+503) 2247-5789 
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 applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Natural medicines for 
human use (International Classification for Standards (ICS) code 11.120.10) 
5. Title, number of pages and language(s) of the notified document:   RTCA 11.03.64:11, 
Productos Farmacéuticos.  Productos Natural es Medicinales para uso humano.  Registro 
Sanitario  (Central American Technical Regulation (RTCA) No. 11.03.64:11:  
Pharmaceutical products.  Natural medicines for human use.  Sanitary registration) 
(19 pages, in Spanish). 
6. Description of content:   The notified Technical Regula tion establishes the conditions and 
requirements for the sanitary registration of natural medicines for human use intended for 
marketing.  The Regulation applies to na tural medicines for human use that are 
manufactured or imported by natural or  legal persons for marketing in the 
Central American region.  It does not a pply to products containing as the constituent 
responsible for pharmacological activity active substances that are chemically synthesized 
or isolated from natural material, or to opht halmic or parenteral pharmaceutical products. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of consumer health G/TBT/N/SLV/160 
Page 2  
 
  8. Relevant documents:  
(a) RTCA Productos Farmacéuticos.  Produc tos Naturales Medicinales para uso 
humano.  Requisitos de Etiquetado  (Central American Technical Regulation on 
Pharmaceutical products.  Natural me dicines for human use.  Labelling 
requirements) - in force; 
(b) RTCA Productos Farmacéuticos.  Produc tos Naturales Medicinales para uso 
humano.  Verificación de la Calidad (Central American Technical Regulation on 
Pharmaceutical products.  Natural medicines for human use.  Quality control) - in 
force. 
9. Proposed date of adoption: 
Proposed date of entry into force:   To be determined 
Six months after adoption 
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 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) 2247-5788 Fax: (+503) 2247-5789 E-mail: datco@minec.gob.sv  
Website: http://www.minec.gob.sv  
Organismo Salvadoreño de Regl amentación Técnica (OSARTEC) 
1ª Calle Poniente y Final 41 Av. Norte N° 18 Colonia Flor Blanca, San Salvador, El Salvador Tel.: (+503) 2247-5323 
E-mail: consultasreglamento@minec.gob.sv