[RegAffairs]Re: Mutual Recognition Procedure - TGA & EMEA

[Jim Tyrrell <jmstyrrll@btinternet.com>]

Thirumurugan

I guess (and it is a guess) is that like any agreement
the MRA will have limitations & exclusions. My
understanding is that the MRA between EU (EEA) & say
TGA is that they rely on each other's audits of
facilities in their own zone of responsibility. A plus
of this for the QP in the EEA is that he/she can be
assured that the facility is operating GMP equivalent
to that required by EU (EEA).

Jim T