G/TBT/N/SLV/182  
21 September 2015  
(15-4831)  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 governme nt involved (Articles 3.2 and 7.2):  
2. Agency responsible: Organismo Salvadoreño de Reglamentación Técnica , OSARTEC 
(Salvadorian Technical Regulation Agency) 
Name and address (including telephon e and fax numbers, email 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 
Dirección de Administración de Tratados Comerciales Alameda Juan Pablo II y Calle Guadalupe, Plan Maestro, San Salvador, El Salvador 
Website: http://www.minec.gob.sv/  
Tel.: (+503) 2590 5788 
Fax: (+503) 2590 5789 
Email: datco@minec.gob.sv  / jmilla@minec.gob.sv  
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): 
International Classification for Standards (ICS): 11.120.01 
5. Title, number of pages and lang uage(s) of the notified document: RTS 11.02.01:15 
- Productos farmacéuticos. Medicamentos de uso humano. Bioequivalencia e intercambiabilidad  (Salvadorian Technical Regulation (RTS) No. 11.02.01:15 - 
Pharmaceutical products. Medicines for human use. Bioequivalence and interchangeability) 
(13 pages, in Spanish)  
6. Description of content: The notified text establishes requirements for demonstrating the 
bioequivalence and interchangeability of multi-origin products, with a view to ensuring their safety, quality and effectiveness. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: To demonstrate that two medicines containing the same dose of the same 
drug are equivalents in terms of quality, effectiveness and consumer safety. 
8. Relevant documents:  
a) PAHO/WHO, PANDRH Technical Document No. 8, Pan American Network on Drug 
Regulatory Harmonization, Framework for Implementation of Equivalence Requirements for Pharmaceutical Products, June 2011. 
b) Acuerdo que determina el tipo de prueba para demostrar intercambiabilidad de 
medicamentos genéricos  (Agreement establishing the type of test used to 
demonstrate the interchangeability of generic medicines), Consejo de Salubridad 
General  (General Health Council), published in the Mexican Official Journal on 
Monday 28 July 2014. G/TBT/N/SLV/182 
- 2 - 
  c) Guía Técnica G-BIOF 02: Bioexención de los estudios de Biodisponibilidad / 
Bioequivalencia para establecer Equivalencia Terapéutica de Formas Farmacéuticas 
Sólidas Orales  (Technical guide G-BIOF 02: Exemption from the obligation to carry 
out bioavailability/bioequivalence studies to determine the therapeutic equivalence 
of oral solid pharmaceutical forms), Sección de Biofarmacia  (Biopharmaceutical 
Unit), Sub departamento de Seguridad  (Sub-department of Safety), Departamento 
de Control National  (National Control Department), Instituto de Salud Pública de 
Chile (Public Health Institute of Chile), 2007. 
d) Lineamientos de una Normativa Común en Bioequivalencia de Medicamentos en 
Centroamérica y Rep. Dominicana  (General outline of a common regulatory 
framework for the bioequivalence of medici nes in Central America and the Dominican 
Republic), Alexis Aceituno, Instituto de Salud Pública de Chile  (Public Health Institute 
of Chile), March 2014. 
e) Norma Oficial Mexicana NOM-177-SSA1-2013, Que establece las pruebas y 
procedimientos para demostrar que un medicamento es intercambiable. Requisitos a que deben sujetarse los Terceros Autorizados que realicen las pruebas de 
intercambiabilidad. Requisitos para realizar los estudios de biocomparabilidad. 
Requisitos a que deben sujetarse los Terceros Autorizados, Centros de Investigación o Instituciones Hospitalarias que realicen las pruebas de biocomparabilidad  (Mexican 
Official Standard NOM-177-SSA1-2013 es tablishing tests and procedures to 
demonstrate the interchangeability of a medicine. Requirements to be met by authorized third parties that conduct interchangeability tests. Biocomparability study 
requirements. Requirements to be met by au thorized third parties, research centres 
and hospitals that conduct biocomparability tests). 
f) Oficio Nº. S00/ 1586 /2013, COFEPRIS, Lineamientos Para los Casos en los que no 
existe correspondencia con el Medicamento Alopático de Referencia Indicado como 
tal, por la Secretaria de Salud  (Note No. S00/1586/2013, COFEPRIS. Guidelines 
applicable where there is no correspondence with the allopathic reference drug designated as such by the Ministry of Health), Mexico D.F., 2013. 
9. Proposed date of adoption: 18 September 2015 
Proposed date of entry into force: 18 September 2015  
10. Final date for comments: - 
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresse s, if available, of other body:  
Ministerio de Economía 
Dirección de Administración de Tratados Comerciales Alameda Juan Pablo II y Calle Guadalupe, Plan Maestro 
San Salvador, El Salvador 
Website: http://www.minec.gob.sv/  
Tel.: (+503) 2590 5788 
Fax: (+503) 2590 5789 
Email: datco@minec.gob.sv  / jmilla@minec.gob.sv  
Organismo Salvadoreño de Reglamentación Técnica (OSARTEC) 
1ª Calle Poniente y Final 41 Av. Norte, N° 18, Colonia Flor Blanca 
San Salvador, El Salvador 
Website: http://www.osartec.gob.sv/  
Tel.: (+503) 2590 5323; (+503) 2590 5335 
Email: consultasreglamento@osartec.gob.sv  
https://members.wto.org/crnattachments/2015/TBT/SLV/15_3701_00_s.pdf