E-DRUG: Country of Origin (cont)
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Mr. Reggi provided a competent view on the issue of the country of
origin of a pharmaceutical product.
I find one point debatable: the obligatory MA issued in the country
where the party accepting full responsibility is located.
...the authorities of country B. At this point, if they decide to
rely on
the authority of country B and the product has a marketing
authorization in country B, then country C can assume that the GMP
profile of the manufacturer and the quality dossier of the product
have been assessed by country B and found acceptable...
In my view, this CAN be the MA in the country B (the country of the
party taking on the full responsibility), but it COULD also be
am MA of an authority in another state, however such-a-one which enjoys
the reputation of high of high competence in the area, e.g. from of the
authority in another (selected case by case) member state of the EU,
or in a (e.g.a leading ICH) overseas country
One point further;
country C needs to ascertain 1) whether QC lab methods for the final
dosage form are applicable at the national QC lab, i.e. whether they
will be able to carry out routine controls on the imported product,
I believe the European OMCL (Official Medicines Control Laboratories)
Network should be given a role here as an alternative site for QC
testing of (selected) products. In other words, some routine tests
may fall out of the competence of the national laboratory. In my view
it is not rational to repeat routine testing in each state for every
product but to learn to rely on the competence of the partners in the
network.
Prof.Dr. Stanislav Primozic, M.Pharm.
National Coordinator
Pharmaceuticals Programme
WHO Liaison Office
Ljubljana, Slovenia
Email: <primozis@ffa-server.ffa.uni-lj.si>
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