jag009
★★★

NJ,
2023-01-17 15:57
(436 d 09:06 ago)

Posting: # 23427
Views: 1,459
 

 Biowaiver for site transfer in Mexico [Regulatives / Guidelines]

Hi,
Does anyone know if Mexico allows biowaiver for site transfer of products if new manufacturing site is located in Brazil? Or a PK study is needed?
thx
J
Ricardo
☆    

Mexico,
2023-02-08 02:59
(414 d 22:04 ago)

@ jag009
Posting: # 23445
Views: 997
 

 Biowaiver for site transfer in Mexico

Mexico does not accept biowaivers right now, you should be submitting the study according to the test indicated by the Consejo de Salubridad General.

Here is the link to the official site: http://www.csg.gob.mx/contenidos/priorizacion/consultiva-cientifica.html
Only available in Spanish.
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
69 visitors (0 registered, 69 guests [including 7 identified bots]).
Forum time: 01:04 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5