E-drug: Re: Double or dubious standards for regulation and export?
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Dear E-druggers - again,
I am sure you know the feeling when there are just too many issues
to handle at the same time and it is easy to be confused? Well it
happened to me when writing this posting and unfortunately I got
the story slightly wrong:
The drug had been rejected twice by the Sri Lankan regulatory
authority before it was approved the third time, by what looked like
unusual methods. In fact it is not known from the story whether the
company ever tried to get it registered in Denmark. But, as I put it,
it has been approved in other European countries within and outside
the EU.
Let me also use this opportunity to add that the use of the WHO
Certification Scheme would have given information on the product's
registration status in the country of origin. According to a reliable
source all EU members are obliged to actually use the updated
version of the model certificate and comply with it. The latter
requests clear answers about not only the registration status in the
country of export, but also about whether or not a product is
actually marketed in the exporting country. Information can be
found here:
(http://www.who.int/medicines/library/qsm/who-edm-qsm-2000-2/c
ertifscheme.htm) NB long URL, remember to 'repair' before clicking.
Cheers, Kirsten
Kirsten Myhr, MScPharm, MPH
Head of Eastern Region Drug Information Centre
RELIS Ost
Ulleval University Hospital
N-0407 OSLO
Tel: +47 23 01 64 11 Fax: +47 23 01 64 10
kirsten.myhr@relis.ulleval.no (w)
myhr@online.no (h)
www.relis.no
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