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RegisterReference Drug for EU Submission [Study Performance]
Dear All,
Can any one tell me what is the procedure to get reference drug selection for Europe submission. is there any updated RLD list like US FDA.
With addition to this, is it mandate to conduct fasting and fed both study for EU submission?
Regards,
Auditor
Can any one tell me what is the procedure to get reference drug selection for Europe submission. is there any updated RLD list like US FDA.
With addition to this, is it mandate to conduct fasting and fed both study for EU submission?
Regards,
Auditor
Complete thread:
- Reference Drug for EU Submissionauditor 2012-02-08 10:15
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Reference Drug for EU Submission drgunasakaran1 2012-02-08 11:38
- Reference Drug for EU Submission Vardhan82 2012-02-08 13:35
- Centralised procedure: one reference Helmut 2012-02-08 13:46
Ing. Helmut Schütz