Regulatory Updates

Distribution date: 12 April 2022

This resolution contains provisions on minimum requirements to guarantee the quality of imported medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 12 April 2022

This resolution contains provisions on the minimum requirements for granting and cancelling the adoption of the parametric release to replace the sterility test with Anvisa.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 12 April 2022

This resolution contains provisions on the minimum requirements for granting and cancelling the adoption of the parametric release to replace the sterility test with Anvisa.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 12 April 2022

This normative instruction contains provisions on Good Manufacturing Practices complementary to Pressurized Aerosol Medicines Metered for Inhalation

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 12 April 2022

This normative instruction contains provisions on Good Manufacturing Practices complementary to Pressurized Aerosol Medicines Metered for Inhalation

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 12 April 2022

The Resolution number 563, 15 September 2021 - previously notified through G/TBT/N/BRA/1265 - which provides, in an extraordinary and temporary manner, the requirements for the import and use of human immunoglobulin, due to the international public health emergency related to SARS-CoV-2., was changed by Resolution - RDC number 673, 30 March 2022. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6326437/RDC_673_2022_.pdf/f1888898-83db-483b-b101-a8a0bb63f442

Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); HEALTH CARE TECHNOLOGY (ICS code(s): 11)

Regulation Type: Addendum to Regular Notification

Distribution date: 12 April 2022

The Resolution number 563, 15 September 2021 - previously notified through G/TBT/N/BRA/1265 - which provides, in an extraordinary and temporary manner, the requirements for the import and use of human immunoglobulin, due to the international public health emergency related to SARS-CoV-2., was changed by Resolution - RDC number 673, 30 March 2022. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6326437/RDC_673_2022_.pdf/f1888898-83db-483b-b101-a8a0bb63f442

Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); HEALTH CARE TECHNOLOGY (ICS code(s): 11)

Regulation Type: Addendum to Regular Notification

Distribution date: 12 April 2022

This normative instruction contains provisions on Good Manufacturing Practices complementary to the sampling activities of raw materials and packaging materials used in the manufacture of medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 12 April 2022

This normative instruction contains provisions on Good Manufacturing Practices complementary to the sampling activities of raw materials and packaging materials used in the manufacture of medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 12 April 2022

This resolution contains provisions on minimum requirements to guarantee the quality of imported organic products.

Products Covered: HS (29) - Organic Products 

Regulation Type: Regular notification