(143 d 02:41 ago)
Posting: # 23427
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?
(121 d 15:39 ago)
Posting: # 23445
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.