E-drug: Views on parallel imports
---------------------------------------------
The discussion on steps being taken by other countries to legalise
parallel imports is very pertinent for us. We are facing the dilemma of
developing appropriate provisions in our legislation.
1) How do we ensure that the "parallel import" source is a bona fide
manufacturer unless we can access some batch certification
scheme?. Would regulators of exporting countries be willing to
give such certificates to any party?.
2) What happens to the licensing status of the "parallel import" when
the original licence/registration falls away due to a marketing
decision by the holder of the principal licence?.
3) Is it reasonable to insist that only those "parallel imports" of similar
packaging and labelling to the approved principal product be
permitted on the market?. This would be done in an effort to
safeguard against counterfeit and to minimise confusion on the
market.
Gugu N. Mahlangu (Ms)
Director-Medicines Control
Medicines Control Authority of Zimbabwe
P O Box UA 559
Union Avenue, HARARE
Fax: 263-4-736980
Phone: 263-4-736981/5
"mcaz" <mcaz@africaonline.co.zw>
[The WHO Certification Scheme addresses many of the issues you raised.
www.who.int/medicines/teams/qsm/certifscheme.html
Pacific Island Nations are examples of countries that have developed
additional mechanisms to ensure quality and compliance with
specifications. BS co-moderator]
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<DIV><FONT color=3D#000000>Dear e-druggers</FONT></DIV>
<DIV><FONT color=3D#000000></FONT> </DIV>
<DIV>The discussion on steps being taken by other countries to legalise =
parallel=20
imports is very pertinent for us. We are facing the dilemma of =
developing=20
appropriate provisions in our legislation.</DIV>
<DIV> </DIV>
<DIV>1) How do we ensure that the "parallel import" =
source is a=20
bona fide </DIV>
<DIV> manufacturer unless we can access some =
batch=20
certification </DIV>
<DIV> scheme?. Would regulators of =
exporting=20
countries be willing to </DIV>
<DIV> give such certificates to any =
party?.</DIV>
<DIV> </DIV>
<DIV>2) What happens to the licensing status of the "parallel =
import" when </DIV>
<DIV> the original licence/registration falls =
away due=20
to a marketing </DIV>
<DIV> decision by the holder of the principal=20
licence?.</DIV>
<DIV> </DIV>
<DIV>3) Is it reasonable to insist that only those "parallel=20
imports" of similar </DIV>
<DIV> packaging and labelling to the approved =
principal=20
product be </DIV>
<DIV> permitted on the market?. This would =
be done=20
in an effort to </DIV>
<DIV> safeguard against counterfeit and to minimise =
confusion=20
on the </DIV>
<DIV> market.</DIV>
<DIV> </DIV>
<DIV> </DIV>
<DIV>Gugu N. Mahlangu (Ms)</DIV>
<DIV>Director-Medicines Control </DIV>
<DIV>Medicines Control Authority of Zimbabwe</DIV>
<DIV>P O Box UA 559</DIV>
<DIV>Union Avenue, HARARE</DIV>
<DIV> </DIV>
<DIV> </DIV>
<DIV>Fax: =
263-4-736980</DIV>
<DIV>Phone: 263-4-736981/5</DIV>
<DIV> </DIV>
<DIV> </DIV>
<DIV> </DIV>
<DIV> </DIV>
<DIV> </DIV>
<DIV> </DIV></BODY></HTML>
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