. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/MEX/167 
10 February 2009 
 (09-0625) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:  MEXICO
 
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:   Secretaría de Economía (Ministry of the Economy) 
Name and address (including telephone and fax numbers and E-mail and website 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above: 
Comité Consultivo Nacional de Normaliz ación de Regulación y Fomento Sanitario  
(National Advisory Committee on Standardiza tion for the Regulation and Promotion of 
Health) Secretaría de Salud  (Ministry of Health) 
Monterrey, No. 30, PH 
Col. Roma, Delegación Cuauhtémoc 
México, D.F. 06700 Tel.: 55-14-85-50 Fax: 55-11-14-99 E-mail: nidiacoyotee@salud.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):   Establishments engaged 
in the manufacture and/or importation of medicines marketed in Mexico, and warehouses 
which package, store and distribute medicin es and the raw materials required for their 
manufacture. 
5. Title, number of pages and lang uage(s) of the notified document:  
NOM-059-SSA1-2006, Buenas pr ácticas de fabricación para establecimientos de la 
industria químico farmacéutica dedicados a la fabricación de medica mentos (modifica a la 
NOM-059-SSA1-1993, publicada el 31 de julio de 1998)  (Mexican Official Standard 
NOM-059-SSA1-2006:  Good manufacturing practices for establishments in the chemico-pharmaceutical industry engaged in th e manufacture of medicines (amendment to 
Mexican Official Standard NOM-059-SSA1-1993, published on 31 July 1998)) (39 pages, 
in Spanish).  
6. Description of content:   The notified Mexican Official Standard sets forth the minimum 
requirements for the manufacture of medicin es marketed in Mexico to ensure that 
consumers are supplied with good quality products .  Compliance with this Mexican Official 
Standard must be demons trated and documented. G/TBT/N/MEX/167 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:  
The notified Standard sets forth the minimum requirements for the manufacture of 
medicines marketed in Mexico to ensure that consumers are supplied with good quality 
products. 
This Standard is binding on all establishm ents engaged in the manufacture and/or 
importation of medicines marketed in Mexi co, and warehouses which package, store and 
distribute medicines and the raw materials required for their manufacture. 
8. Relevant documents:   Diario Oficial de la Federación  (Official Journal) of 
22 December 2008.  Available at:  http://www.dof.gob.mx. 
9. Proposed date of adoption: 
 
Proposed date of entry into force:  180 calendar days after publication in the 
Official Journal 
180 calendar days after publication in the 
Official Journal 
10. Final date for comments:   - 
11. Texts available from:  National enquiry point [ X] or address, telephone and fax 
numbers, E-mail and website addresses,  if available, of other body:  
General Directorate of Standards of the Ministry of the Economy 
Tel.: (+52) 55 5729-9300, Ext. 43217 
Fax: (+52) 55 5520-9715 Website: http://www.economia-noms.gob.mx/ E-mail: normasomc@economia.gob.mx Website: http://members.wto.org/crna ttachments/2009/tbt/MEX/09_0364_00_s.pdf