G/TBT/N/MEX/284
27 February 2015
(15-1165)  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 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.: 50805200, Ext. 1333 
Email: rfs@cofepris.gob.mx  
Or:  
 
Dirección General de Normas  (General Directorate of Standards)  
Subsecretaría de Competitividad y Normatividad  (Undersecretariat of Competitiveness and 
Standardization) 
Secretaría de Economía  (Ministry of the Economy) 
Av. Puente de Tecamachalco Núm. 6 Col. Lomas de Tecamachalco, Sección Fuentes 
Naucalpan de Juárez, C.P. 53950, Estado de México 
Tel.: 52 29 61 00, Ext. 43244 Email: sofia.pacheco@economia.gob.mx  and/or normasomc@economia.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): Drugs, 
medicaments and herbal remedies under headings 30.02 and 30.03, other drugs and/or 
medicaments under Chapter 30, and herbal remedies under heading 33.01 used for 
therapeutic or prophylactic purposes. 
5. Title, number of pages and language(s) of the notified document: PROY-NOM-073-
SSA1-2014, Estabilidad de fármacos y medicamentos, así como de remedios herbolarios  
(Draft Mexican Official Standard PROY -NOM-073-SSA1-2014, Stab ility of drugs, 
medicaments and herbal remedies) (21 pages, in Spanish) 
6. Description of content: The notified Standard is binding on factories or laboratories 
handling raw materials for the preparation of medicaments or biological products for human use, factories or laboratories manufacturing medicaments or biological products for human use, and factories or laboratories manufacturing herbal remedies, which market 
their products in the United Mexican States. G/TBT/N/MEX/284 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable: The notified text establishes the specifications and requirements for the 
stability studies that are to be carried out on drugs, medicaments and herbal remedies for 
human use that are marketed in national territory. 
8. Relevant documents:  
• Norma Oficial Mexicana NOM-008-SCFI-2002, Sistema General de Unidades de 
Medida  (Mexican Official Standard NOM-008-SC FI-2002: General system of units of 
measurement); 
• 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-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-164-SSA1-2013, Buenas prácticas de fabricación para 
fármacos  (Mexican Official Standard NOM-164-SSA1-2013: Good manufacturing 
practices for medicines); 
• Norma Oficial Mexicana NOM-248-SSA1-2011, Buenas prácticas de fabricación para 
establecimientos dedicados a la fabricación de remedios herbolarios  (Mexican Official 
Standard NOM-248-SSA1-2011: Good manufacturing practices for establishments engaged in the manufacture of herbal remedies); 
• Farmacopea de los Estados Unidos Mexicanos  (Pharmacopoeia of the United Mexican 
States), current edition and supplements thereto; 
• International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline 
Q1B: Stability Testing: Photostability Testing of New Drug Substances and Products (Nov. 1996). Available at: 
http://www.ich.org/%20fileadmin/Public_Web _Site/ICH_Products/Guidelines/Quality
/Q1B/Step4/Q1B_Guideline.pdf; 
• International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline 
Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and 
Drug Products (Feb. 2002). Available at: http://www.ich.org/fileadmin/Public_Web_S ite/ICH_Products/Gui delines/Quality/Q1
D/Step4/Q1D_Guideline.pdf . 
9. Proposed date of adoption: 60 calendar days after publication in the Official Journal 
(Diario Oficial de la Federación ). 
Proposed date of entry into force: The notified Mexican Official Standard will enter into 
force after being published as a final standard in the Official Journal ( Diario Oficial de la 
Federación ). More specifically, it will enter into force on the day following that on which the 
General Directorate of Standards of the Ministry of the Economy issues a notice confirming the existence of the infrastructure required for its implementation.  
10. Final date for comments: - G/TBT/N/MEX/284 
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  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=5383484&fecha=26/02/2015  
https://members.wto.org/crnattachments/2015/TBT/MEX/15_0972_00_s.pdf