E-DRUG: Bioavailability studies for all generics? (2)
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I answer your messages regarding parallel import and bioavailability
studies in connection with the regulatory situation in some Latin
American countries as well as the MercoSur system (Argentina - Brazil
- Uruguay - Paraguay - Chile - Bolivia and Peru common market).
Parallel imports are legally authorized in Argentina according to the
recent legislation on intellectual property rights which follows WTO
agreements. As far as I know those provisions were not challenged by
the USA government although other parts of that legislation are being
higly critized by the USA pharmaceutical industry with strong USA
government backing.
With regard to bioavailability requriments for registration of generic
products, the MercoSur regulations requires those studies only on
those cases when there are not dissolutions standards or other
pharmacopeial standards already established and accepted. In general
terms in these countries bioavailability studies are required as an
exception for the registration of generic products. I can provide you
with more detailed information. You have take in consideration as well
a draft WHO document on this subject that has been published in WHO
Drug Information in 1995 or 1996. Regards,
Marcelo J. Vernengo
Universidad de Belgrano
Buenos Aires
Argentina
Email: vernengo@ub.edu.ar
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