. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/MEX/242 
1 October 2012 
 (12-5284) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Notifying Member:   MEXICO 
If applicable, name of local government 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 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) Website: http://www.cofepris.gob.mx  
3. Notified under Article 2.9.2 [ ], 2.10.1 [X], 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):   Biotechnological 
medicines and biopharmaceuticals (Interna tional Classification for Standards (ICS) 
code 07.030)  
5. Title, number of pages and lang uage(s) of the notified document:  
NOM-EM-001-SSA1-2012, Medicamentos biot ecnológicos y sus biofármacos.  Buenas 
prácticas de fabricación.  Características técnicas y científicas que deben cumplir estos, 
para demostrar su seguridad, eficacia y calidad .  Etiquetado.  Requisitos para realizar los 
estudios de biocomparab ilidad y farmacovigilancia  (Emergency Mexican Official Standard 
NOM-EM-001-SSA1-2012:  Biotechnological medicines and biopharmaceuticals.  Good 
manufacturing practices.  Technical and scientific requirements to ensure the safety, effectiveness and quality of these products .  Labelling.  Biocomparability and 
pharmacovigilance study requirements) (40 pages, in Spanish) 
6. Description of content:  The notified text is binding for sanitary registration holders, 
establishments engaged in the processing of biopharmaceuticals and biotechnological medicines, anyone applying for the sanitary registration of biotechnological products, authorized third parties, and research centr es or hospitals conducting biocomparability tests 
and other tests determined by the Ministry of Health. G/TBT/N/MEX/242 
Page 2  
 
  7. Objective and rationale, including the nature of urgent problems where applicable:  
To establish requirements for the sanitary control of biopharmaceuticals and 
biotechnological medicines: 
- Minimum requirements for good manufacturing practices for biopharmaceuticals 
and biotechnological medicines; 
- technical and scientific requirements to ensure the safety, effectiveness and quality 
of biotechnological medicines; 
- labelling and instruction requirements for biotechnological medicines; 
- criteria and requirements applicable to t hose applying for the sanitary registration 
of biotechnological products, authorized third parties, and research centres or 
hospitals that conduct tests to demonstrat e the biocomparability of biocomparable 
biotechnological medicines; 
- guidelines concerning pharmacovigilance activities for biotechnological medicines. 
8. Relevant documents:   ICH Q7A:  Good Manufacturing Practice Guide for Active 
Pharmaceutical Ingredients (November 2000)  
9. Proposed date of adoption: 
Proposed date of entry into force: The notified Standard will enter into force the day 
after its publication in the Official Journal for a period of six months.  
10. Final date for comments:   Not applicable  
11. Texts available from:  National enquiry  point [X] or address, telephone and fax 
numbers and e-mail and website addresses, 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 jesus.figueroa@economia.gob.mx  
Website: http://www.economia.gob.mx/comunidad- negocios/normalizacion/catalogo-
mexicano-de-normas  
 
Text available online at: http://dof.gob.mx/index.php? year=2012&month=09&day=20 
http://members.wto.org/crnattach ments/2012/tbt/MEX/12_3837_00_s.pdf