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

posted by Abhay Patil – India, 2021-03-23 08:58 (24 d 20:59 ago) – Posting: # 22289
Views: 350

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
21,419 posts in 4,475 threads, 1,508 registered users;
online 13 (0 registered, 13 guests [including 6 identified bots]).
Forum time: Saturday 06:57 CEST (Europe/Vienna)

I never did anything worth doing by accident,
nor did any of my inventions come by accident;
they came by work.    Thomas Alva Edison

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