E-DRUG: Re: E-DRUG Veterinary Medicines

[Kirsten Myhr <myhr@online.no>]

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E-DRUG Veterinary Medicines

In Norway and I think it is the same in the other Nordic countries,
veterinary drugs are handled in the same way as human drugs. Which means
they have to be approved by the regulatory authority. In our case,
veterinarians are employed to handle the registration files and do the
summary, but e.g. evaluation of toxicity studies and pharmaceutical issues
are handled by the same units doing human drugs. Since most toxicology
studies for human drugs are done in animals, I would assume there is no need
to separate these evaluations. I do not know whether the documentation for
clinical studies is less extensive, but could investigate or put you in
contact with persons more familiar with it. As for other pre-clinical data,
for drugs to be used for domestic animals and fish, data on residual levels
after use has to given. The Medicines Control Authority will them give the
number of days, weeks or months which must pass before the animal (fish) can
be milked or slaughtered.

The registration applies to both drugs for treatment of disease and for
preventive use e.g. in fish and animal food, vaccines for fish etc. For
antibiotics, an advisory body exists similar to one that we have for human
use. One member of the advisory body for antibiotics for human use is also
member of the one for vet use because of the implications that use in
veterinary practice have for e.g. resistance problems.

The use of certain vet. drugs, particularly in food, is monitored by a
special veterinary information centre staffed by pharmacists. The Ministry
of Agriculture who is the responsible ministry, is very keen to start
registration of all prescriptions and it will be part of the new national
prescription-based drug statistics databse which hopefully will start
operating next year.

As far as I know, everybody seems satisfied with this situation. Not least a
very successful reduction in the use of antibiotics for fish farms which has
been achieved by cooperation between all relevant bodies, has proven the
value of the present system.

I should also add that all drugs have to be purchased through a pharmacy. We
have no dispensing doctors either and I think it has been shown over and
over again that it is wise to separate prescribing and dispensing. This
applies of course as much to veterinarians as to physicians!

There are some EU-directives on this either out or in process I think,
please look up the EU web site.

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



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