E-DRUG: Transparence of origin (2)
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[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.
It depends what manufacturing is meant. If the raw material is manufactured
elsewhere, but the final compounding has been performed in a European
country, I would say that the drug is manufactured in Europe, under full
responsibility of the compounder.
If there has only been a process of repackaging, or inserting leaflets,
then the country of the compounding would be the country of origin in my
view, and possibly also legally.
On these matters I would rather ask an expert on legal liability for an
advice than pharmacists or the pharmaceutical industry. GMP rules have been
established by the industry, as far as I know. They certainly are not
independent.
Foppe