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Regulatory Report


The Brazilian Health Regulatory Agency (ANVISA) provides detailed guidelines for the qualification of pharmaceutical inputs’ suppliers – Normative Instruction (IN) n. 62/2020 specifies the guidelines for the qualification of suppliers of pharmaceutical inputs announced in Resolution n. 204/2006 of the Board of Directors (RDC)

New rules for aircraft operation and maintenance come into force – The Brazilian Regulation for Civil Aviation n. 91 (RBAC n. 91) replaces the Brazilian Requirements for Aeronautical Certification n. 91 (RBHA n. 91) and applies to general aviation aircraft

New rules to the Non-produced Auto Parts Regime – Four resolutions change the list of products covered by the regime and the applicable rules.

Public consultations on relevant themes launched – The Brazilian Ministry of Agriculture, Livestock, and Food Supply (MAPA) opened three public consultations regarding normative initiatives related to agricultural defense, the use of biological and microbiological products in pest control, and the registration of phytochemical and microbiological products

Launch of the National Bio Inputs Program – The Program aims at implementing strategic initiatives for the development of economically viable and ecologically sustainable alternatives for agricultural and livestock production that guarantee healthy products for the Brazilian and international society

Brazil’s National Trade Facilitation Committee (CONFAC) is relaunched – The collegiate member of the Brazilian Foreign Trade Council (CAMEX) supports trade facilitation initiatives and coordinates government bodies engaged in foreign trade

New measures to reduce bureaucracy: 14 activities exempted from licenses and permits to operate

New measures to reduce bureaucracy: rules for public registration of companies have been consolidated in a single Normative Instruction

Launch of the National Bio Inputs Program – The Program aims to implement strategic actions for the development of economically viable and ecologically sustainable alternatives for agricultural and livestock production that guarantee healthy products for the Brazilian and international society.

Brazil’s National Trade Facilitation Committee (CONFAC) is relaunched – The collegiate member of the Brazilian Foreign Trade Council (CAMEX) supports trade facilitation initiatives and coordinates government bodies engaged in foreign trade.

Resolution n. 55/2020 and Resolution n. 56/2020 of the Ministry of Economy updated the list of capital goods (BK) and telecommunications goods (BIT) subject to the temporary exemption on the Import Tax granted by the “ex-tariff” regime.

New measures to reduce bureaucracy: 14 activities exempted from licenses and permits to operate