G/TBT/N/MEX/293  
18 September 2015  
(15-4793)  Page: 1/3  
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): 
Medicaments (HS 30.04) 
5. Title, number of pages and lang uage(s) of the notified document: Proyecto de 
norma oficial mexicana PROY-NOM-059-SSA1-20 15, Buenas prácticas de fabricación de 
medicamentos (87 pages, in Spanish)  (Draft Mexican Official  Standard PROY-NOM-059-
SSA1-2015: Good manufacturing practices for me dicinal products) (87 pages, in Spanish) 
6. Description of content: The notified Standard is binding on all establishments engaged in 
the manufacture and/or importation of medicinal products for human use marketed in 
Mexico and/or medicinal products for research purposes, as well as on quality control laboratories and warehouses which package, store and distribute medicinal products and 
the raw materials required for their manufacture. 
7. Objective and rationale, including the nature of urgent problems where 
applicable: To establish the minimum requirements for the manufacturing process for 
medicinal products for human use marketed in Mexico and/or medicinal products for 
research purposes. 
8. Relevant documents:  
 Norma Oficial Mexicana NOM-002/1-SCT/2009, Listado de las substancias y materiales 
peligrosos más usualmente transportados, instrucciones y uso de envases y embalajes, recipientes intermedios para graneles (RIG S), grandes envases y embalajes, cisternas portátiles, contenedores de gas de elementos múltiples y 
contenedores para graneles para el transporte de materiales y residuos peligrosos  
(Mexican Official Standard NOM-002/1-SCT/2009: List of the most frequently transported hazardous substances and materials; instructions regarding containers, 
packaging, intermediate bulk containers (IBC), large containers and packaging, 
portable tanks, multiple-element gas containers, and bulk containers used to transport G/TBT/N/MEX/293 
- 2 - 
  hazardous materials and waste) 
 Norma Oficial Mexicana NOM-002-SEMARNAT-1996, Que establece los límites 
máximos permisibles de contaminantes en las descargas de aguas residuales a los 
sistemas de alcantarillado urbano o municipal  (Mexican Official Standard NOM-002-
SEMARNAT-1996 establishing the maximum permissible levels of contaminants in waste water released into urban or municipal sewage systems) 
 Norma Oficial Mexicana NOM-005-STPS-1998, Relativa a las condiciones de seguridad 
e higiene en los centros de trabajo para el manejo, transporte y almacenamiento de sustancias químicas peligrosas  (Mexican Official Standard NOM-005-STPS-1998 on 
occupational health and safety requirements governing the handling, transport and 
storage of hazardous chemical substances) 
 Norma Oficial Mexicana NOM-020-STPS-2011, Recipientes sujetos a presión, 
recipientes criogénicos y generadores de vapor o calderas - Funcionamiento - 
Condiciones de Seguridad  (Mexican Official Standard NOM-020-STPS-2011: 
Pressurized containers, cryogenic vessels and steam generators or boilers - Operation - Safety requirements) 
 Norma Oficial Mexicana NOM-026-STPS-2008, Colores y señales de seguridad e 
higiene, e identificación de riesgos por fluidos conducidos en tuberías  (Mexican Official 
Standard NOM-026-STPS-2008: Signs and colours for safety and health, and 
identification of risk of accidents by fluids conducted in pipes) 
 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) 
 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) 
 Norma Oficial Mexicana NOM-072-SSA1-2012, Etiquetado de medicamentos y de 
remedios herbolarios  (Mexican Official Standard NOM-072-SSA1-2012: Labelling of 
medicines and herbal remedies) 
 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-087-SEMARNAT-SSA1-2002, Protección ambiental - 
Salud ambiental - Residuos peligrosos biológico-infecciosos - Clasificación y 
especificaciones de manejo  (Mexican Official Standard NOM-087-SEMARNAT-SSA1-
2002: Environmental protection - Environmental health - Hazardous bio-infectious residues - Classification - Handling specifications) 
 Norma Oficial Mexicana NOM-164-SSA1-2013, Buenas prácticas de fabricación para 
fármacos  (Mexican Official Standard NOM-164-SSA1-2013: Good manufacturing 
practices for pharmaceutical products) 
 Norma Oficial Mexicana NOM-220-SSA1-2012, Instalación y operación de la fármaco 
vigilancia  (Mexican Official Standard NOM-220- SSA1-2012: Introduction and operation 
of pharmacovigilance) 
 Norma Oficial Mexicana NOM-241-SSA1-2012, Buenas prácticas de fabricación para 
establecimientos dedicados a la fabricación de dispositivos médicos  (Mexican Official 
Standard NOM-241-SSA1-2012: Good manufacturing practices for establishments engaged in the manufacture of medical devices) 
 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) 
 Norma Oficial Mexicana NOM-257-SSA1-2014, En materia de medicamentos 
biotecnológicos  (Mexican Official Standard NOM-257-SSA1-2014 on biotechnological 
medicines)  
9. Proposed date of adoption: - 
Proposed date of entry into force: 180 calendar days after publication in the Official 
Journal.  G/TBT/N/MEX/293 
- 3 - 
  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=5407940&fecha=09/09/2015 
https://members.wto.org/crnattachments/2015/TBT/MEX/15_3654_00_s.pdf