G/TBT/N/MEX/253  
11 March 2013  
(13-1306)  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: Ministry of Health 
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 Standardization for the Regulation and Promotion of Health) 
Oklahoma número 14, planta baja Colonia Nápoles 
Código postal 03810, México, D.F. 
Tel.: 50-80-52-00, Ext. 1333 Fax: 55-11-14-99 
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): 
Good manufacturing practices for medicines (ICS 11.120.10). 
5. Title, number of pages and lang uage(s) of the notified document: Proyecto de 
Norma Oficial Mexicana PROY-NOM-164-SSA1-2013, Buenas prácticas de fabricación para fármacos  (Good manufacturing practices for medicines) (43 pages, in Spanish)  
6. Description of content:  
The notified draft Standard establishes the minimum requirements for the manufacture of 
medicines and active substances marketed in Mexico and medicines developed for use in clinical research. 
The Standard is binding on all establishmen ts engaged in the manufacture of medicines 
and active substances marketed in Mexico and medicines developed for use in clinical 
research, and warehouses that distribute medicines and active substances. 
Authorized manufacturing activities: 
List of products indicating at least the generic name, the manufacturer(s) of the active 
substance, and the process carried out by the establishment (production, packaging, 
labelling, distribution, quality control and release). Where products are imported, this fact 
must be indicated, as well as the process carried out and the year in which the product 
was first marketed. Where the product is not marketed, the date it ceased to be marketed and the reason for this must also be indicated. G/TBT/N/MEX/253 
- 2 - 
  7. Objective and rationale, including the nature of urgent problems where 
applicable: To protect human health and ensure the quality and purity of medicines. 
8. Relevant documents:  
- EudraLex. Volume 4, Good Manufacturing Practice (GMP) Guidelines, Part II, 
Basic Requirements for Active Substances Used as Starting Materials. 
February 2010; 
- Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation 
Scheme. Explanatory notes for Pharmaceutical Manufacturers on the Preparation of 
a Site Master File. January 2011; 
- US Food and Drug Administration. Guidance for Industry Process Validation: 
General Principles and Practices. Washington, January 2011; 
- ICH Q7: Good Manufacturing Practice Guidance for Active Pharmaceutical 
Ingredients (November 2000); 
- ICH Q9: Quality Risk Management (November 2005); 
- ICH Q10: Pharmaceutical Quality System (June 2008). 
9. Proposed date of adoption:   
Proposed date of entry into force:   Not applicable. 
The day after its publication as a final Mexican 
Official Standard in the Official Journal. 
10. Final date for comments: 3 May 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=03&day=05 
http://members.wto.org/crnattachments/2013/tbt/MEX/13_1062_00_s.pdf