Biowaiver for site transfer in Mexico [Regulatives / Guidelines]

posted by jag009  – NJ, 2023-01-17 15:57 (462 d 05:01 ago) – Posting: # 23427
Views: 1,558

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

Complete thread:

UA Flag
Activity
 Admin contact
22,993 posts in 4,828 threads, 1,652 registered users;
69 visitors (1 registered, 68 guests [including 13 identified bots]).
Forum time: 21:58 CEST (Europe/Vienna)

If you don’t like something change it;
if you can’t change it, change the way you think about it.    Mary Engelbreit

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