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[RegAffairs]Re; Labelling problems for less developed markets

Dear Chandra,

I used to work for a major multi-national company who export products
virtually every country.  If you are working in an international
environment, you should expect to handle the nuances of all the local
legislation.  Unfortunately there is little or no pressure towards
harmonisation of labelling requirements, even in the EU which is supposed to
be a single market.

The company had exactly the problem which you describe. For the developed
markets they produced market specific packs.  For the less developed markets
they had region specific packs which could be overstickered/overprinted as
necessary with local information.  They managed to produce packs for regions
such as North Africa (French), West Africa (French and English) and East
Africa (English), middle East (English), Latin and south America (Spanish).

I would suggest you ask your local representative/agent in each market for
specific advice and to supply representative product so that you can
establish whether there are any market specific features. Ideally, it should
be the same product from each market  You could also try asking the local
regulatory agency for information.

You may also consider whether it would be more convenient to establish a
regional packaging centre(s) to distribute the load of multiple product
lines.

Good luck,

Steve Binysh
Acta Pharma Services Ltd


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