G/TBT/N/MEX/255  
22 March 2013  
(13-1588)  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) 
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 di fferent 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 
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 Arti cle 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], other:   
4. Products covered (HS or CCCN wher e applicable, otherwise national tariff 
heading. ICS numbers may be provid ed in addition, where applicable):  
Good manufacturing practices for medicinal products (International Classification for Standards (ICS) code 11.120.10). 
5. Title, number of pages and lang uage(s) of the notified document:  Proyecto de 
Norma Oficial Mexicana PROY-NOM-059-SSA1-20 13, Buenas prácticas de fabricación de 
medicamentos (Draft Mexican Official Standard PROY-NOM-059-SSA1-2013: 
Good manufacturing practices for medicinal products) (57 pages, in Spanish).  
6. Description of content:  The notified draft Mexican Official Standard establishes 
the minimum requirements for the manufacturing process for medicines for human use marketed in Mexico and/or medicines for research purposes. 
The notified draft Standard is binding on all establishments engaged in the manufacture 
and/or importation of medicines for human use marketed in Mexico and/or medicines for research purposes, as well as on quality control laboratories and warehouses which 
package, store and distribute medicines and the raw materials required for 
their manufacture. 
Pharmaceutical manufacturing systems are required to follow written procedures 
to ensure compliance with Good Manufacturing Practices (GMPs). The characteristics 
of each system are determined by the nature  of the processes, the pharmaceutical form 
and the quality specifications of each product, inter alia . G/TBT/N/MEX/255 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health and quality. 
8. Relevant documents:  
- EudraLex. Volume 4, Good Manufacturing Practice (GMP) Guidelines. 
Introduction, Part I, Part III and Annexes 1, 2, 6, 8, 9, 11,  13, 14, 15 and 19; 
- Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation 
Scheme. Explanatory notes for Pharmaceutical Manufacturers on the Preparation of 
a Site Master File. January 2011; 
- Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation 
Scheme. Guide to Good Manufacturing Prac tice for Medicinal Products, Annexes. 
September 2009; 
- Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation 
Scheme. Guide to Good Manufacturing Practice for Medicinal Products, Part I. September 2009; 
- Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation 
Scheme. Guide to Good Manufacturing Practice for Medicinal Products, Part II. September 2009; 
- Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation 
Scheme. PIC/S GMP Guide for Blood Establishments. September 2007; 
- Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation 
Scheme. GMP, Annex 1, Revision 2008, Inte rpretation of Most Important Changes 
for the Manufacture of Sterile Medicinal Products. January 2010; 
- WHO. Technical Report Series, No. 961, 2011, Annex 3: Good manufacturing practices 
for pharmaceutical products: Main principles. Geneva, 2011; 
- WHO. Technical Report Series, No. 961, 2011, Annex 4: Guidelines on good 
manufacturing practices for blood establishments. Geneva, 2011; 
- World Health Organization. Recommendations for the evaluation of animal cell 
cultures as substrates for the manufacture of biological medicinal products and for the 
characterization of cell banks. 2010; 
- US Food and Drug Administration. Title 21, Parts 11 and 211, Code of Federal 
Regulations. Washington, Government Printing Office, 2012; 
- US Food and Drug Administration. Guidance for Industry, Process Validation: General 
Principles and Practices. Washington, January 2011; 
- US Food and Drug Administration. Guidance for Industry, CGMP for Phase 1 
Investigational Drugs. Washington, 2008; 
- ICH Q5A (R1): Viral safety evaluation of bi otechnology products derived from cell lines 
of human or animal origin (September 1999); 
- ICH Q5B: Quality of biotechnological products: analysis of the expression construct 
in cells used for production of r-DNA derived protein products (November 1995); 
- ICH Q5C: Quality of biotechnological products: stability testing 
of biotechnological/biological products (November 1995); 
- ICH Q5D: Derivation and characterization of cell substrates used for production 
of biotechnological/biological products (July 1997); 
- ICH Q5E: Comparability of biotechnological/biological products subject to changes 
in their manufacturing process (November 2004); 
- ICH Q8 (R2): Pharmaceutical Development (August 2009); - ICH Q9: Quality Risk Management (November 2005); 
- ICH Q10: Pharmaceutical Quality System (June 2008).  G/TBT/N/MEX/255 
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  9. Proposed date of adoption: 
Proposed date of entry into force:   Not applicable.  60 calendar days after the publication of the 
final Mexican Official Standard in the 
Official Journal. 
10. Final date for comments:  13 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=15 
http://members.wto.org/crnattachments/2013/TBT/MEX/13_1205_00_s.pdf