G/TBT/N/MEX/261  
14 May 2013  
(13-2490)  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 different 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): 
Medicinal products (ICS code 03.100) 
5. Title, number of pages and lang uage(s) of the notified document: Proyecto de 
Norma Oficial Mexicana PROY-NOM-257-SSA1-2013, Autorización de medicamentos, 
registro, renovación y modificaciones.  (Draft Mexican Official Standard 
PROY-NOM-257-SSA1-2013: Authorization of me dicinal products, registration, renewal 
and amendments.) (58 pages, in Spanish)  
6. Description of content: The notified text establishes the minimum requirements for the 
authorization of medicinal products for human use that are imported, distributed 
and/or marketed in national territory. It also establishes requirements for the recognition 
of orphan drugs. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health and quality control. 
8. Relevant documents:  
- European Commission, NTA, Vol. 2B-CTD, foreword and introduction, 
edition June 2006; 
- ICH M4: Organisation of the Common Technical Document for the Registration 
of Pharmaceuticals for Human Use (January 2004). G/TBT/N/MEX/261 
- 2 - 
  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_1825_00_s.pdf