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[RegAffairs]Labelling

Dear Forum members,

This is regarding labelling of the pharmaceutical
products for semi and non regulated markets , it has
been observed that each regulatory agency is having
their own set of requirements ... if you compile all
the requirements ..all are similar ,where as the
terminologies are little different.some may require
additional details some may not.

in this scenario is it really necessary to develop
different artworks for each product based on the un
updated website links provide by these agencies?

If the generic company is  able to provide all the
necessary details on the  printed packaging components
, Is it  required to follow the requirements exactly
as mentioned by the agencies ?  Can we request the
agency  to approve the artwork (common artworks )
where all the relevant details has been given . If
they need any additional requirements like reg nos etc
that can be over printed during Packaging operation.

If we need to design different foils for different
countries it results a huge inventory and creates lots
of confusion when the product goes for packaging.there
are chances of Mix ups also.

I feel that  there should be a common guideline to
standardise the labelling requirements where every
agency should accept the format &terminologies instead
of setting their own standards.

Please comment

Regards

Chandra


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