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Application
Form
Certification for Medicine
Bioavailability/Bioequivalence Centers (word)
Renewal
of Certification for Medicine Bioavailability/Bioequivalence
Centers
(word)
The
Coordination of Inspection in Bioequivalence Centers
would like to inform to all the international centers
which have already the certification for medicine bioavailability/bioequivalence
centers that it is necessary to request the
renewal of this certification every year, at
least 60 days before the expire date.
The international centers must present at this time
the specific application form for renewal along with
a list of documents, which are both available at the
link above.
Along with this request, the center must pay the same
amount that was paid for the certification, according
to the regulatory of Fee Collection Form (GRVS). Also,
this Coordination would like to inform that the frequency
of international inspections is annually, but there
are some cases that we can decide to inspect after two
years. |
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Resolution -
RDC nº 103, of May 8, 2003
The Centers that carry out Bioavailability/Bioequivalence
studies for the purpose of medicine registration shall observe
the rules and technical regulations in force
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Bioequivalence
Centers (In Portuguese) |
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Certified
Centers |
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In
process of certification |
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Canceled |
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Bioavailability/Bioequivalence
Good Practices Manual
> First
Volume (compact
archive PDF for download - volume1.zip
-size 6,4 Mb)
> Second
Volume (compact
archive PDF for download - volume2.zip
- size 6,4 Mb) |
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us
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