E-DRUG: Definition of country of origin

E-drug: Definition of country of origin
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[Taken from the RegAffairs conference,
email RegAffairs@ade5.pa.man.ac.uk]

Dear members,

I would be grateful if members could advise me as to the definition of
the term 'county of origin' of a medicine.

If the medicine is manufactured in country A but shipped to country B
for bottling and packing before final export into C. As far as country
C is concerned, should the product's country of origin be A? It could
not be country B because packaging is only a small part of the
manufacturing process.

However, in the above case, if the product is also registered with the
Health Authority of the packing country B and sold there after
packaging. Then for C is concerned, which one will be the country of
origin?

Thank you in advance of any advice.

Regards

Joseph Kwong
Hospital Authority of Hong Kong
Email: Joseph KWONG Tai-wing <jtwkwong@ha.org.hk>

[This question is important for the WHO Certificates in the
import/export trade. Maybe WHO/DMP has an answer?
Remember the 'round-tripping' of the sub-standard glycerine in the
Haiti poisoning case, where the raw material went from China (?)
to Holland to Germany to Haiti.WB, E-drug mod.]

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