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

posted by Abhay Patil – India, 2021-03-23 09:58 (1212 d 16:37 ago) – Posting: # 22289
Views: 7,451

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:

UA Flag
Activity
 Admin contact
23,107 posts in 4,858 threads, 1,644 registered users;
62 visitors (0 registered, 62 guests [including 7 identified bots]).
Forum time: 03:35 CEST (Europe/Vienna)

All paid jobs absorb and degrade the mind.    Aristotle

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