The Brazilian Health Regulatory Agency (ANVISA) revised the administrative procedures related to the concession of certificates of Good Manufacturing Practices and Good Distribution and/or Storage Practices. The update aims at streamlining those procedures and reducing regulatory burdens.
RDC Resolution n. 497/2021 from the Brazilian Health Regulatory Agency (ANVISA) revised the administrative procedures related to the concession of Certificates of Good Manufacturing Practices (CBPF, in the Portuguese acronym) and of Certificates of Good Distribution and/or Storage Practices (CBPD/A, in the Portuguese acronym). The update is designed to simplify the procedures and reduce regulatory-related costs.
The new resolution replaced RDC Resolution n. 39/2013 in order to optimize the administrative procedures related to the granting of CBPF and CBPD/A for imported or domestically produced drugs, health products, cosmetics, fragrances, hygiene products, sanitizing products, active pharmaceutical ingredients, and food. Specific criteria for each product are provided in chapter “III” (articles 12 to 34), while general criteria are provided in chapter “II” (articles 4 to 11).
According to ANVISA, the new resolution included a CBPF administrative procedure for food, removed redundant requirements (already provided on other norms), expanded the CBPD/A validity to four years, and aligned specific active pharmaceutical ingredients certificates to RDC Resolution n. 362/2020. Altogether, the update is designed to provide a streamlined administrative process for those certificates, also seeking to reduce regulatory burdens.
More information on the regulation of products and companies can be found at ANVISA’s website.
