ANVISA Moving Brazil GMP Inspection Fee from Annual to Biennial Schedule
Brazil’s National Agency for Sanitary Surveillance (ANVISA) will purportedly begin charging inspection fees for Certificates of Good Manufacturing Practice and Quality Control (Brazil GMP) every two years rather than on an annual basis.
According to the Brazilian Association of Equipment Importers, Products and Medical Supplies, 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.