. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/MEX/193 
24 March 2010 
 (10-1613) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:  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 Standardiza tion for the Regulation and Promotion of 
Health) Monterrey número 33, planta baja Colonia Roma 
06700, México, D.F. 
Tel.:  5080 5200, Ext. 1480 Fax:  5511 1499 E-mail: rfs@cofepris.gob.mx Website: http://www.salud.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):   Pharmacopoeia 
5. Title, number of pages and lang uage(s) of the notified document:  
PROY-NOM-001-SSA1-2009, Que instituye el pr ocedimiento por el cual se revisará, 
actualizará y editará la farmacopea de lo s Estados Unidos Mexicanos (modifica a la 
NOM-001-SSA1-1993, publicada el 17 de junio de 1994) (Draft Mexican Official Standard 
PROY-NOM-001-SSA1-2009 establishing the proc edure for the revision, updating and 
editing of the Pharmacopoeia of the United Mexican States (amending 
NOM-001-SSA1-1993, published on 17 June  1994)) (8 pages, in Spanish). G/TBT/N/MEX/193 
Page 2  
 
  6. Description of content:   The notified Mexican Official St andard is binding on the Ministry 
of Health through the Executive Directorate of  Pharmacopoeia and Pharmacovigilance of 
the Federal Commission for the Prevention of  Sanitary Risks, and on the Permanent 
Pharmacopoeia Commission of Mexico, as well as on any parts of the public and private 
sector which participate in revising, updati ng and amending the content of the Mexican 
Pharmacopoeia and its supplements.  Th e Mexican Pharmacopoeia is a document 
established under the General Law on Health, is sued and recognized by the Ministry of 
Health, which sets forth general methods of  analysis and identity, purity and quality 
requirements with a view to ensuring that drugs, additives, medicines, biological products and medical devices are functional, effective and safe, in accordance with the country's 
needs. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
To establish guidelines on the procedure for revising, updating, editing and disseminating 
the Mexican Pharmacopoeia and its supplements. 
8. Relevant documents:   Diario Oficial de la Federación  (Official Journal) of 5 March 2010.  
Available at: http://www.dof.gob.mx/  
9. Proposed date of adoption: 
Proposed date of entry into force:  Upon publication as a Mexican Official 
Standard in the Official Journal. 
60 calendar days after publication in the 
Official Journal. 
10. Final date for comments:   4 May 2010 
11. Texts available from:  National enquiry  point [X] or address, telephone and fax 
numbers, 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 
Website:  http://www.economia-noms.gob.mx/?P=144
 
E-mail:  normasomc@economia.gob.mx and/or figueroa@economia.gob.mx 
Also available at:  http://members.wto.org/crnatt achments/2010/tbt/mex/10_1196_00_s.pdf