G/TBT/N/MEX/262  
14 May 2013  
(13-2491)  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: MEXICO 
If applicable, name of local governme nt involved (Articles 3.2 and 7.2):   
2. Agency responsible: Secretaría de Salud  (Ministry of Health) 
Name and address (including telephone and fax numbers and e-mail 
and website addresses, if available) of ag ency or authority designated to handle 
comments regarding the notification shall be indicated if diffe rent from above: 
Comité Consultivo Nacional de Normalización de Regulación y Fomento Sanitario  
(National Advisory Committee on Standardization for the Regulation and Promotion 
of Health) 
Oklahoma número 14, planta baja 
Colonia Nápoles 
Código postal 03810, México, D.F. Tel.: (+52) 55 5080-5200, Ext. 1333 
Fax:  (+52) 55 5511-1499 
E-mail: rfs@cofepris.gob.mx  
Website: http://www.cofepris.gob.mx  
 
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): 
Interchangeable medicines and biotechnological medicines (ICS code 03.120.20). 
5. Title, number of pages and lang uage(s) of the notified document: Proyecto de 
Norma Oficial Mexicana PROY-NOM-177-SSA1-2013, Que establece las pruebas 
y procedimientos para demostrar que un medicamento es intercambiable y un medicamento biotecnológico es biocomparable. Requisitos a que deben sujetarse 
los Terceros Autorizados, Centros de Investigación o Instituciones Hospitalarias 
que realicen las pruebas.  (Draft Mexican Official St andard PROY-NOM-177-SSA1-2013 
establishing tests and procedures to demons trate that a medicine is interchangeable 
and a biotechnological medicine biocomparable, and the requirements to be met 
by authorized third parties, research centres and hospitals that conduct such tests.) (71 pages, in Spanish) G/TBT/N/MEX/262 
- 2 - 
  6. Description of content:  
The notified text establishes the following: 
- the criteria and requirements to be observed when conducting tests 
to demonstrate the interchangeability of generic medicines, and the requirements to be met by authorized third parties that conduct such tests; 
- the criteria and requirements to be observed when conducting tests 
to demonstrate the biocomparability of biotechnological medicines, and the 
requirements to be met by authorized thir d parties, research centres and hospitals 
that conduct such tests. 
The text is binding on all authorized third parties that conduct tests to demonstrate 
interchangeability, and on authorized third parties, research centres and hospitals that conduct tests to demonstrate biocomparability.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health and quality control. 
8. Relevant documents: NMX-EC-17025-IMNC-2006. Requisitos generales para la 
competencia de los laboratorios de ensayo y de calibración . (Mexican Standard 
NMX-EC-17025-IMNC-2006: General requirements for the competence of testing 
and calibration laboratories.)  
9. Proposed date of adoption: 
Proposed date of entry into force:   Not applicable. 
60 days after the publication of the final Mexican Official Standard in the 
Official Journal. 
10. Final date for comments: 4 July 2013 
11. Texts available from: National enquiry point [X], or address, telephone and fax 
numbers and e-mail and website addresse s, if available, of other body:  
Secretaría de Economía 
Subsecretaría de Competitividad y Normatividad 
Dirección General de Normas 
Tel.: (+52) 55 5729-9100, Ext. 43217 Fax: (+52) 55 5520-9715 E-mail:  normasomc@economia.gob.mx  and/or jesus.figueroa@economia.gob.mx  
Website: " http://www.economia.gob.mx/comuni dad-negocios/c ompetitividad-
 normatividad/normalizacion/catalogo-mexicano-de-normas " 
Text available online at: 
http://www.dof.gob.mx/index.p hp?year=2013&month=05&day=06 
http://members.wto.org/crnattachments/2013/tbt/MEX/13_1833_00_s.pdf