Dear Forum Members,
We have our facility approved by TGA. We are planning on EU market
for some of our products. In this case, since the facility has
already been approved by TGA, will it Trigger an inspection by EU ????
Are there any "Mutual Recognition Procedures" applicable in this case.
We are trying to avoid the inspection by EU.
Unlike FDA, EU & TGA go by facility approval rather than product
based approvals.
Can anyone give some links or suggestions in this regard. Response is
highly appreciated.
Regards,
Thirumurugan G
thiru7@yahoo.co.uk
|