G/TBT/N/SLV/212  
20 November  2020 
(20-8387) 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 government involved (Articles 3.2 and 7.2):  
2. Agency responsible : Organismo Salvadoreño de Reglamentación Técnica , OSARTEC 
(Salvadoran Technical Regulation Agency)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regardin g the notification shall be indicated if different from above:  
Ministerio de Economía  (Ministry of the Economy)  
Dirección de Administración de Tratados Comerciales  (Directorate for the Administration 
of Trade Agreements)  
Alameda Juan Pablo II y Calle Guadalupe, Plan Maestro, San Salvador, El Salvador  
Website: http://www.minec.gob.sv  
Tel.: (503) 2590 5788  
Email: datco@minec.gob.sv  
3. Notified under Article 2.9.2 [ ], 2.10.1 [X], 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 a ddition, where applicable) : Other 
standards related to pharmaceutics ( ICS 11 .120.99)  
5. Title, number of pages and language(s) of the notified document : Reglamento 
Técnico Salvadoreño RTS 11 .02.03:20 Productos farmacéuticos . Productos naturales 
medicinales para uso humano . Buenas Prácticas de manufactura y su guía de verificación 
(Salvadoran Technical Regulation RTS 11 .02.03:20 : Pharmaceutical products . Natural 
medicines for human use . Good manufacturing practices, and verification manual) (76 
pages, in Spanish)  
6. Description of content : The notified Regulation establishes the principles and guidelines 
for good manufacturing practices that regulate all procedures involved in the manufacture 
of natural medicines for human use, in order to ensure the effectiveness, safety and 
quality of such products.  
The Regulation applies to all laboratories authorized by the National Directorate of 
Medicines to manufacture natural medicines for human use.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Lay down an urgent legal basis at the national level for the functioning of 
laboratories that manufacture natural medicines, so as to ensure gradual compliance with 
good manufacturing practices ; Other G/TBT/N/SLV/212  
- 2 - 
  8. Relevant document s: 
• RTCA Reglamento Técnico Centroamericano de Productos Farmacéuticos . 
Productos Naturales Medicinales para uso humano . Requisitos de Registro 
Sanitari o (current version);  
• RTCA Reglamento Técnico Centroamericano de Productos Farmacéuticos . 
Verificación de la calidad de productos naturales . Productos Naturales Medicinales 
para uso humano  (current version);  
• RTCA Reglamento Técnico Centroamericano de Productos Farmacéuticos . 
Etiquetado de Productos Naturales . Productos Naturales Medicinales para  uso 
humano  (current version).  
9. Proposed date of adoption : 5 November 2 020 
Proposed date of entry into force : 20 November 2 020 
10. Final date for comments : Not applicable  
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
https://members.wto.org/crnattachments/2020/TBT/SLV/20_7090_00_s.pdf