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

Hello everyone,

We manufacture OTC Products (Monograph & Generics). I felt the same 
way Steve has mentioned like, Once there is an MRA in place and we 
know all the agencies are short of inspectors and funds for review 
and site inspection, why shouldn't they accept the certification by 
the other agency.

Our site is inspected by TGA and Certified. Why shouldn't MHRA/EMEA 
accept this Certification even if the manufacturing site is in US.

What is the issue with location??? If this is an issue, then the 
purpose of having an MRA in place between these countries is not 
served!!!

This is just my opinion. We could still discuss this...I would be 
delighted to hear more suggestions.

Regards,
Thiru
thiru7@yahoo.co.uk


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