Reference Drug for EU Submission [Study Per­for­mance]

posted by Vardhan82 – India, 2012-02-08 14:35 (5248 d 07:17 ago) – Posting: # 8076
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Dear 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.


There's no 'EU RLD'! For a European submission for marketing authorisation an innovator's product from any European member state may be used as a reference. You may get the reference product details in country specific sites.


Regards,

Vardhan.P
Clinical Scientist

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