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

posted by Abhay Patil – India, 2021-03-23 09:58 (1071 d 23:54 ago) – Posting: # 22289
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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

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