prashant modi
●    

2006-10-14 14:48
(6787 d 04:11 ago)

Posting: # 319
Views: 5,519
 

 renewal criteria for ANVISA [Regulatives / Guidelines]

Dear All

Please let me know the renewal procedure and criteria for ceritificaiton for BA/BE centers for ANVISA,Brazil

prm
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2006-10-14 22:24
(6786 d 20:36 ago)

@ prashant modi
Posting: # 321
Views: 4,419
 

 renewal criteria for ANVISA

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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,671 registered users;
181 visitors (0 registered, 181 guests [including 6 identified bots]).
Forum time: 19:00 CEST (Europe/Vienna)

Only dead fish go with the current.    Scuba divers' proverb

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5