Regulatory Submission in Europe in Absence of Reference product [Regulatives / Guidelines]

posted by Abhay Patil – India, 2021-03-23 08:58 (131 d 21:33 ago) – Posting: # 22289
Views: 6,168

Hi,
We would like to know the regulatory submission in Europe in absence of Refrence product in europe. Reference product (RLD) is available in other countries like Singapore, Australia, NZ but not available in Europe (also not in uk )
Its a Fixed dose combination but all Individual dosage are available in Europe both Refernce as well as Generic and also under WEU category

Need your guidance to overcome this matter

Thanks and regads

Abhay Patil

Complete thread:

Activity
 Admin contact
21,596 posts in 4,516 threads, 1,532 registered users;
online 7 (0 registered, 7 guests [including 3 identified bots]).
Forum time: Monday 07:31 CEST (Europe/Vienna)

Imagine if every Thursday your shoes exploded
if you tied them the usual way.
This happens to us all the time with computers,
and nobody thinks of complaining.    Jef Raskin

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