E-drug: Transparence of origin
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Dear E-druggers
Does anyone of you have information on documentation showing how and under
what circumstances drugs manufactured outside the EU can legally be
labelled "Made in [a EU country or the EU]" simply because they have been
repacked or labelled in a EU country?
Merci
Valerio Reggi
WHO/DMP
CH 1211 Geneva 27
Switzerland
Email: reggiv@who.ch
[This is an important question. The background for this question is the
current practice by some companies where drugs produced outside the EU are
repacked from bulk and relabelled inside the EU. Technically (under GMP
rules) relabelling is manufacturing, so indeed the last 2% of the
'manufacturing' was done in the EU. But of course it would be important to
know (and have indicated on the label) where the remaining 98% was
manufactured. If the current practice is legal, it 'hides' the real
manufacturer, pretending the product comes from an EU country.
Ideally, there should be a 'chain' responsibility to put all manufacturing
details (raw material, bulk production, retail labelling) on the label or
accompanying documentation.
Wilbert Bannenberg, E-drug co-moderator
Email: WilbertBannenberg@compuserve.com]
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