E-DRUG: Transparency of origin (2)
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The issue of country of origin (originating product) I think is found in an
EU document called Protocol 4. I have spent some time trying to find it on
the EUR-lex website, but find only a list of amendments to it. So,
unfortunately I cannot give you any more specific reference. This document
is not related to medicinal products only.
In a Norwegian book on EU legislation I have found part of the document
translated. The following is a translation back into English of what I find
must be the relevant section:
Protocol 4, Section II Definition of term originating product
Article 5 Insufficient processing or finishing
1. The following processes are to be regarded as insufficient processing or
finishing to give a product status as originating product, regardless of
whether the terms in Article 4 (products sufficiently processed or finished)
has been fulfilled:
a) a process with the aim of keeping the products in their original
condition during transport or storage (ventilation, drying, cooling,
preservation, removal of damaging parts etc.)
b) simple operations such as reomving dust, sifting, separation,
collocation, sorting, washing, painting and cutting;
c) i) changing of packaging material, dividing or collocation of colli;
ii) simple filling of bottles, flacons, bags, boxes, sticking to sheets
etc. and all other simple wrapping up;
d) putting emblem, label or other similar markings on the product itself or
on the package;
e) simple mixing of products, also of different kind, when one or more of
the ingredients in the mixture does not fulfill the terms put down in this
protocol for being able to regard the product as being originating withing EU;
f) simple composition of parts with the aim of producing a complete product;
g)combination of two or more of the processes put down in letter a( to f);
h) slaughtering of animals
2. All processing done in EEC on a given product shall be judged together
when determining whether the processing or finishing the product has
undergone, shall be regarded as insufficient in accordance with nr. 1.
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When we are concerned about a potential misuse of the label, it is of course
because we assume 'Made in EU' is put there because the manufacturer thinks
it is a good sales argument. According to a colleague (inspector), who is
more familiar with EU legislation (but not too familiar with this particular
part) it is not likely that EU will intervene to control the labelling 'Made
in EU', at least not if it is intended for export. Hence it is up to
importing country to control. E.g. when a company applies for market
authorisation, our Medicines Control Authority will demand documentation on
where the product originated.
In an earlier discussion (January 1998), Valerio Reggi gave a good reply on
the principles of country of origin. I think also Michael Anisfield gave a
good list of observations he has made on how parts of the manufacturing
process might be done in different countries. In my opinion this is a
similar issue.
He also commented on a particular case presented by Joseph Kwong. I did not
participate then, but would like to comment on what Valerio said about
asking for a full dataset and WHO-type certificates for all manufacturers
involved when receiving drugs from a supplier which only did repackaging.
When I worked in Africa, after several episodes with a socalled manufacturer
in Germany which only did repackaging, simple test of identity and strength,
then made out his own certificates of analysis and put his own labels on the
boxes, I was quite concerned with German authorities giving the company
manufacturing licence for this. According to EU legislation however,
companies repackaging may be given manufacturing licence. This was probably
intended to enable stricter control of such manufacturers and thus ensure
better quality. The company would then for sale within EU be the responsible
body for the whole manufacturing process. The opposite effect, which happens
when European companies only manufacture/repackage for non-European market
and thus do not follow EU regulations and guidelines, was probably not intended.
It was not immidiately evident that this company only did repackaging. It
was only known to me when I visited the manufacturer. We had for all
products received documentation as if the company was manufacturing these
drugs themselves so how should we know. When we discovered this and demanded
documentation on the acutal manufacturer, we were told that that was a
company secret. We stopped buying from them of course, but as you see, it is
not always so easy neither to know nor to act on knowledge. Except of course
on suspicion, in which case you should exclude the company from tendering.
In conclusion, for any part of the manufacturing process legally done within
EU, the last in the chain will by EU be held responsible for the whole
process. Most Regulatory Authorities will demand documentation of sites for
the whole process. The problem is for non-European countries without
regulatory authorities and which buys on international tenders to get all
the documents needed to find the which companies are involved. Unfortunately
such documents are not easy to obtain. I agree with Wilberts comment on what
the situation should have been!
Regards Kirsten
Ms Kirsten Myhr, MScPharm, MPH
Bygdoy alle 58B
0265 Oslo, Norway
Tel: +47 22 56 05 85 (h)
Fax: +47 22 24 90 17 (w) Tel: +47 22 24 88 55 (w)
E-mail: myhr@online.no
[Kirsten - thanks for this very informative contribution. Other
experiences from other E-druggers? WB]
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