G/TBT/N/MEX/262/Add.5  
7 November  2023 
(23-7511) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
  
NOTIFICATION  
Addendum  
The following communication, dated 7 November 2 023, is being circulated at the request of the 
delegation of Mexico . 
 
_______________  
 
 
Title: Proyecto de Norma Oficial Mexicana PROY -NOM-177-SSA1 -2013, Que establece las pruebas 
y procedimientos para demostrar que un medicamento es intercambiable y un medicamento 
biotecnológico es biocomparable . Requisitos a que deben sujetarse los Terceros Autorizados, Centros 
de Investigación o Instituciones Hospitalarias q ue realicen las pruebas  (Draft Mexican Official 
Standard PROY -NOM-177-SSA1 -2013 establishing tests and procedures to demonstrate that a 
medicine is interchangeable and a biotechnological medicine biocomparable, and the requirements 
to be met by authorized third parties, research centres and hospitals that conduct such tests)  
 
Reason for Addendum:  
[ ] Comment period changed - date:  
[ ] Notified measure adopted - date:  
[ ] Notified measure published - date:  
[ ] Notified measure enters into force - date:  
[ ] Text of final measure available from1: 
[ ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:  
[ ] Content or scope of notified measure changed and text available from1: 
New deadline for comments (if applicable):  
[ ] Interpretive guidance issued and text available from1: 
[X] Other:  
Reply to the comments received on Draft Mexican Official Standard PROY -NOM-177-
SSA1 -2013 establishing tests and procedures to demonstrate that a medicine is 
interchangeable and a biotechnological medicine biocomparable . Requirements to be 
met by authorized third parties that conduct interchangeability tests . Biocomparability 
study requirements . Requirements to be met by authorize d third parties, research 
 
1 This information can be provided by including a website address, a PDF attachment, or other 
information on where the text of the final measure/change to the measure/interpretative guidance can be 
obtained.  G/TBT/N/MEX/262/Add.5  
- 2 - 
  centres and hospitals that conduct biocomparability tests, published in the Official 
Journal on 2 5 May 2 022. 
https:// www.dof.gob.mx/nota_detalle.php?codigo=5699657&fecha=24/08/2023#gsc.
tab=0  
https://members.wto.org/crnattachments/2023/TBT/ME X/23_13360_00_s.pdf  
 
Description : Pursuant to Articles 39 of the Organic Law of the Law on the Organization of the 
Federal Public Administration ; 4 of the Federal Law on Administrative Procedures ; 3(XXIV and XXV), 
17 bis(III and VI), 100, 102, 194, 194 bis, 195, 214, 221, 222, 222 bis, 257, 258, 259, 260(I), 376, 
376 bis and 391 bis of the General Law on Health ; 30, 34, 35, 37, 38 and 41 of the Law o n Quality 
Infrastructure ; 28 and 33 of the Regulations implementing the Federal Law on Metrology and 
Standardization regarding the Third Transitional Article of the Decree issuing the Law on Quality 
Infrastructure and repealing the Federal Law on Metrology  and Standardization ; 2(VII bis 2 and XIII 
bis 1), 11, 72, 73, 100, 122, 177 bis 1, 177 bis 2, 177 bis 3, 177 bis 4, 177 bis 5 and 211 of the 
Regulations for Health Inputs ; and 3(I)(b) and (II), 10(IV and VIII) of the Regulations of the Federal 
Commission for Protection against Sanitary Risks.  
The comments received from the various interested parties were analysed and responded to by the 
National Advisory Committee on Standardization for the Regulation and Promotion of Health, and 
publication was ordered in  the Official Journal of the document containing the response to the 
comments received on the draft amendment of various items of the Mexican Official Standard NOM -
177-SSA1 -2013 establishing tests and procedures to demonstrate that a medicine is 
interchang eable . Requirements to be met by authorized third parties that conduct interchangeability 
tests. Biocomparability study requirements . Requirements to be met by authorized third parties, 
research centres and hospitals that conduct biocomparability tests, pu blished in the Official Journal 
on 25 May 2 022. 
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