G/TBT/N/SLV/193  
21 December 2016  
(16-6992) 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 Reglam entación Técnica , OSARTEC 
(Salvadorian Technical Regulation Agency)  
Name and address (including telephone and fax numbers and email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall b e indicated if different from above:  
Ministerio de Economía  (Ministry of the Economy)  
Dirección de Administración de Tratados Comerciales  (Directorate of Trade Treaty 
Administration)  
Alameda Juan Pablo II y Calle Guadalupe, Plan Maestro, San Salvador, El S alvador  
Website: http://www.minec.gob.sv/  
Tel.: (+503) 2590 5788  
Fax: (+503) 2590 5789  
Email: datco@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) : 11.120.01  
5. Title, number of pages and language(s) of the notified document : Reglamento 
Técnico Salvadoreño RTS 11.02.01:16 Productos Farmacéuticos . Medicamentos de Uso 
Humano . Bioequivalencia e Intercambiabilidad  (Salvadorian Technical Regulation 
(RTS)  11.02.01:16 : Pharmaceutical products . Medicines for human use . Bioequivalence 
and interchan geability) (22 pages, in Spanish)  
6. Description of content : The notified text establishes requirements for demonstrating 
the bioequivalence and interchangeability of multi -origin medicinal products, with a view 
to ensuring their safety, quality and effe ctiveness.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Regarding pharmaceutical products, it must be scientifically demonstrated 
that two medicines containing the same dose of the same drug are equivalents in ter ms 
of quality, effectiveness and safety for the recipient patient, thus ensuring tha t consumer 
health is properly protected.  
8. Relevant documents:  
• Ley de Medicamentos, Decreto Legislativo No. 1008 (Law on Medicines, Legislative 
Decree No. 1008), publi shed in Official Journal No. 43, Volume 394, of 2 March 2 012, 
San Salvador.  
• Guideline on the Investigation of Bioequivalence , European Medicines Agency (EMA), 
January 2 010. Available online at:  G/TBT/N/SLV/193  
- 2 - 
   http://www.ema.europa.eu/docs/en_GB/document_library/Scient ific_guideline/2010/
01/WC500070039.pdf  
 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 prue bas 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 establishing 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 authorized third parties, research centres 
and hospitals that conduct biocomparability tests)  
 Oficio Nº . S00/1586/2013, COFEPRIS, Lineamientos Para los Casos en los que no 
existe correspondencia con el Medicamento Alopático de Referenci a 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.  
 PAHO/WHO, PANDRH Technical Report No. 8, Pan American Network on Drug 
Regulatory Harmonization, Framework for Implementation of Equivalence 
Requirements for Pharmaceutical Products, June 2 011. 
 United States Pharmacopeia (USP) 39, National Formulary 34, 2016.  
 Waiver of In V ivo Bioavailability and Bioequivalence Studies for Immediate -Release 
Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System . 
Guidance for Industry . Draft Guidance . FDA/CDER, May 2 015. 
9. Proposed date of adoption:  
Proposed date of entry  into force:   To be determined.  
To be determined.  
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 email and website addresses, if availa ble, 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  
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/2016/TBT/SLV/16_5229_00_s.pdf