Definition of Generic Drug in Mexico [Regulatives / Guidelines]

posted by jag009  – NJ, 2021-01-05 01:25 (1199 d 20:21 ago) – Posting: # 22172
Views: 972

(edited by jag009 on 2021-01-05 20:40)

Sorry all, I mean for Mexico not Brazil (damn NY hangover...)

Happy NY everyone,

Can someone help me understand the term generic drug in Mexico? I am currently working with my Mexico counterpart on a product which 1) the active ingredient exists in market and 2) the type of formulation exist in market but there is no product in the market which contains the active ingredient for that particular formulation. In my mind the product is a new drug product since such product does not exist in the market. However, my so-called experts down there told me that our new product can be filed as a generic :confused: Is that possible (in Mexico)?


Complete thread:

UA Flag
 Admin contact
22,986 posts in 4,823 threads, 1,668 registered users;
48 visitors (0 registered, 48 guests [including 5 identified bots]).
Forum time: 22:46 CEST (Europe/Vienna)

Art is “I”; science is “we”.    Claude Bernard

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