May 10, 2011

Brazil’s National Agency for Sanitary Surveillance (ANVISA) has officially confirmed that inspection fees for Certificates of Good Manufacturing Practice and Quality Control (Brazil GMP) will now be charged every two years rather than on an annual basis.

Recent confirmation from ANVISA substitute president director Dirceu Brás Aparecido Barbano reads:

“In response to the letter n. CT 022/2011 of last 27th of January, which requests the regulation of Law No. 11.972/2009, concerning the amendment of the term of validity of the Certificate of Good Manufacturing Practices (GMP), I inform you that the Board of this Agency, in a meeting on February 2, 2011, decided that the understanding of the legal department of ANVISA would be adopted. So, the charge of the inspection fee will be in accordance with the term of renewal of the GMP Certificate, in other words, every two years.”

ANVISA’s move is intended to clear up confusion stemming from § 1 of Article 1 of Law No. 11972 established in 2009, which mandated annual quality system inspection fees even though Brazil GMP certification is renewable on a two-year basis. The regulator ratified requirements on March 22; collection rates now coincide with validity timeframes.

During years in which Brazil GMP quality system inspection is not scheduled, manufacturers should perform self inspections and submit reports of those inspections to ANVISA.


  • Stewart Eisenhart