jag009
★★★

NJ,
2023-01-17 15:57
(1260 d 11:31 ago)

Posting: # 23427
Views: 4,584
 

 Biowaiver for site transfer in Mexico [Regulatives / Guidelines]

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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
(1239 d 00:29 ago)

@ jag009
Posting: # 23445
Views: 3,457
 

 Biowaiver for site transfer in Mexico

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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.
 
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