Biowaiver for site transfer in Mexico [Regulatives / Guidelines]

posted by jag009  – NJ, 2023-01-17 15:57 (512 d 20:19 ago) – Posting: # 23427
Views: 1,754

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
23,056 posts in 4,840 threads, 1,641 registered users;
85 visitors (1 registered, 84 guests [including 10 identified bots]).
Forum time: 13:16 CEST (Europe/Vienna)

Everything is trivial, if you know the answer.    Thomas Jaki

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