Bioequivalence and Bioavailability Forum • Regulatory Submission in Europe in Absence of Reference product

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

posted by Abhay Patil – India, 2021-03-23 09:58 (1400 d 06:24 ago) – Posting: # 22289
Views: 8,090

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:

Regulatory Submission in Europe in Absence of Reference productAbhay Patil 2021-03-23 08:58 [Regulatives / Guidelines]
- Regulatory Submission in Europe in Absence of Reference product dshah 2021-03-23 09:51
  - Regulatory Submission in Europe in Absence of Reference product Abhay Patil 2021-03-23 10:00
    - Regulatory Submission in Europe in Absence of Reference product drgunasakaran1 2021-05-20 07:20