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RegisterRegulatory Submission in Europe in Absence of Reference product [Regulatives / Guidelines]
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
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]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- 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 dshah 2021-03-23 09:51
Ing. Helmut Schütz