Brazilian GMP user fees are biannual, Anvisa clarifies
This article was originally published in Clinica
Brazilian regulatory agency Anvisa has formally clarified that its GMP certification-related user fees are payable every two years. The clarification was in response to a request by medtech importers association Abimed concerning doubts over the interpretation of Law 11.972/2009 and details concerning the application of new rules on “good manufacturing and quality assurance practices” certification (CBPFC). The request was also for Anvisa to clarify the term of validity of the certificates. The applicable CBPFC fee is a flat R$37,000 (US$22,825) for firms that manufacture outside Brazil, and R$15,000 for those manufacturing within the country, irrespective of the size of the company or the type of products involved, according to Abimed.
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