G/TBT/N/MEX/294  
18 September 2015  
(15-4794)  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) 
Comisión Federal para la Protección contra Riesgos Sanitarios , COFEPRIS (Federal 
Commission for Protection against Health Risks) 
Name and address (including telephon e and fax numbers, email 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 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 
03810, México, D.F. Tel.: 5080 5200, Ext. 1333 
Email: rfs@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): 
Pharmaceutical products (heading 30) 
5. Title, number of pages and lang uage(s) of the notified document: Proyecto de 
Norma Oficial Mexicana PROY-NOM-164-SSA1-2015, Buenas prácticas de fabricación de fármacos  (Draft Mexican Official Standard PROY-NOM-164-SSA1-2015: Good 
manufacturing practices for pharmaceutical products) (51 pages, in Spanish) 
6. Description of content: This Standard is binding on all establishments engaged in the 
manufacture of pharmaceutical products and active substances marketed in Mexico and 
pharmaceutical products developed for use in clinical research, and warehouses that distribute pharmaceutical products and active substances. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: The notified draft Standard establis hes the minimum requirements for the 
manufacture of pharmaceutical products and active substances marketed in Mexico and 
pharmaceutical products developed for use in clinical research. 
8. Relevant documents:  
 Norma Oficial Mexicana NOM-002-SCFI-2011, Productos preenvasados-Contenido 
neto-Tolerancias y métodos de verificación  (Mexican Official Standard NOM-002-SCFI-
2011: Pre-packaged products - Net content - Tolerances and verification methods) 
 Norma Oficial Mexicana NOM-052-SEMARNAT-2005, Que establece las características, 
el procedimiento de identificación, clasificación y los listados de los residuos peligrosos  
(Mexican Official Standard NOM-052-SEMARNAT-2005 establishing the characteristics, 
identification procedure, classification and lists for hazardous residues) G/TBT/N/MEX/294 
- 2 - 
   Norma Oficial Mexicana NOM-001-SEMARNAT-1996, Que establece los límites 
máximos permisibles de contaminantes en las descargas de aguas residuales en aguas 
y bienes nacionales  (Mexican Official Standard NOM-001-SEMARNAT-1996 establishing 
the maximum permissible levels of contaminants in waste water released into national waters and property) 
 Modificación a la Norma Oficial Mexicana NOM-127-SSA1-1994, Salud ambiental. Agua 
para uso y consumo humano. Límites permisibles de calidad y tratamientos a que 
debe someterse el agua para su potabilización  (Amendment to Mexican Official 
Standard NOM-127-SSA1-1994, Environmental health. Water for human use and 
consumption. Permissible limits and water purification treatment) 
 Norma Oficial Mexicana NOM-059-SSA1-2013, Buenas prácticas de fabricación de 
medicamentos  (Mexican Official Standard NOM-059-SSA1-2013: Good manufacturing 
practices for medicinal products) 
 Norma Oficial Mexicana NOM-073-SSA1-2005, Estabilidad de fármacos y 
medicamentos  (Mexican Official Standard NOM-073-SSA1-2015, Stability of drugs and 
medicines) 
 Norma Oficial Mexicana NOM-062-ZOO-1999, Especificaciones técnicas para la 
producción, cuidado y uso de los animales de laboratorio  (Mexican Official Standard 
NOM-062-ZOO-1999: Technical specifications for the production, care and use of 
laboratory animals) 
 Noma Oficial Mexicana NOM-253-SSA1-2012, Para la disposición de sangre humana y 
sus componentes con fines terapéuticos  (Mexican Official Standard NOM-253-SSA1-
2012 on the provision of human blood and blood components for therapeutic 
purposes)  
9. Proposed date of adoption: - 
Proposed date of entry into force: 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 and email and website addresse s, if available, of other body:  
Secretaría de Economía  (Ministry of the Economy) 
Subsecretaría de Competitividad y Normatividad  (Undersecretariat of Competitiveness and 
Standardization) Dirección General de Normas  (General Directorate of Standards) 
Tel.: (+52) 55 5729 9100, Ext. 43217 
Fax: (+52) 55 5520 9715 Website: http://www.economia-noms.gob.mx/?P=144  
Email: normasomc@economia.gob.mx  and/or sofia.pacheco@economia.gob.mx  
Text available online at: 
http://dof.gob.mx/nota_detalle.php?codigo=5407941&fecha=09/09/2015 
https://members.wto.org/crnattachments/2015/TBT/MEX/15_3655_00_s.pdf