Dear Chandra,
What you said is scientifically right, ideally there should be a
common guideline to standardize the labeling requirements but
practically it may not be possible.
Let me share my views with you.
1.0 Is it required to follow the requirements exactly as mentioned by
the agencies?
It changes from country to country. It is better to follow their
requirements to save time in receiving product approval. One country
has requested us to change the label because we didn't give the
information in the desired order. Countries like Nigeria require
specific product code printed on the label etc.
2.0 Can we request the agency to approve the artwork (common
artworks) where all the relevant details have been given?
Surely you can request an agency, Before that you have to ask
yourself, what if they don't agree? If they don't agree, then you
have to prepare the same label as per their requirements and submit.
Regulatory professionals do not want to argue with agencies, rather
they plan how to submit a dossier or application and receive approval
with least or no queries in shortest possible time.
3.0 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 don't agree with you for this point. Neither it adds huge inventory
nor it causer mix-ups. Regulatory authorities of different countries
will not ask a supplier to change primary or secondary packaging
materials rather they ask them to meet country specific labeling
requirements. Thus it affects only printed matter. (labeling cost is
very small in comparison to manufacturing and raw material cost).
If proper GMP is followed (eg: line clearance) mix up will not happen.
Regards,
RAJANEESH.BR
Regulatory Affairs
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