Generic application: submission to multiple authorities [Regulatives / Guidelines]
Dear B.K. Rao,
There are some possible limitations:
There are some possible limitations:
- the reference product used may not be recognised by the second authority (for instance if you did your study with a US reference product, it won't be accepted in the EU);
- the various regulatory authorities may follow different guidelines. For instance scaling is not done the same way in the US and in the EU.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Generic application bkrao 2015-10-16 08:15 [Regulatives / Guidelines]
- Generic application: submission to multiple authoritiesOhlbe 2015-10-16 11:47