renewal criteria for ANVISA [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2006-10-14 22:24 (7172 d 06:34 ago) – Posting: # 321
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Dear Prashant,

to quote ANVISA:

'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.'


You may download the renewal form listing all necessities from ANVISA's website.

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