Distribution date: 11 May 2022 | Final date for Comment: 05 May 2025

The Draft Resolution No. 1050, 31 May 2021 – previously notified through G/TBT/N/BRA/1193 – which contains provisions on risk assessment and control of potentially carcinogenic nitrosamines in drugs for human use, was adopted as Resolution – RDC number 677, 28 April 2022. The final text is available only in Portuguese and can be downloaded at:http://antigo.anvisa.gov.br/documents/10181/6279847/RDC_677_2022_.pdf/39723d56-7fd4-4f1a-af2d-218358d67540

Products Covered: Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those for transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 11 May 2022 | Final date for Comment: 05 May 2025

The Draft Resolution No. 1050, 31 May 2021 – previously notified through G/TBT/N/BRA/1193 – which contains provisions on risk assessment and control of potentially carcinogenic nitrosamines in drugs for human use, was adopted as Resolution – RDC number 677, 28 April 2022. The final text is available only in Portuguese and can be downloaded at:http://antigo.anvisa.gov.br/documents/10181/6279847/RDC_677_2022_.pdf/39723d56-7fd4-4f1a-af2d-218358d67540

Products Covered: Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those for transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 11 May 2022 | Final date for Comment: 25 June 2022

This draft resolution proposes a review of Resolution – RDC number 98, 08 January 2016, which contains provisions on the criteria and procedures for classifying medicaments as non-prescription medicaments and reclassifying them as prescription medicaments and other measures.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 11 May 2022 | Final date for Comment: 25 June 2022

This draft resolution proposes a review of Resolution – RDC number 98, 08 January 2016, which contains provisions on the criteria and procedures for classifying medicaments as non-prescription medicaments and reclassifying them as prescription medicaments and other measures.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 11 May 2022 | Final date for Comment: 05 May 2025

The Normative Instruction number 130, 30 March 2022 - previously notified through G/TBT/N/BRA/1366 - which contains provisions on Good Manufacturing Practices complementary to Herbal Medicinal products, was rectified. The rectified text is available only in Portuguese and can be downloaded at: https://www.in.gov.br/en/web/dou/-/retificacao-397562871

Products Covered: HS (3003-3004) - Herbal medicinal products

Regulation Type: Addendum to Regular Notification

Distribution date: 11 May 2022 | Final date for Comment: 05 May 2025

The Normative Instruction number 130, 30 March 2022 - previously notified through G/TBT/N/BRA/1366 - which contains provisions on Good Manufacturing Practices complementary to Herbal Medicinal products, was rectified. The rectified text is available only in Portuguese and can be downloaded at: https://www.in.gov.br/en/web/dou/-/retificacao-397562871

Products Covered: HS (3003-3004) - Herbal medicinal products

Regulation Type: Addendum to Regular Notification

Distribution date: 11 May 2022 | Final date for Comment: 05 May 2025

This resolution contains provisions on bacteria-based sanitizing products, a result of the consolidation of previous regulations, without change of merit.This resolution incorporates into the national legal system the MERCOSUR/GMC Resolution number 63/14.

Products Covered: HS (3402) - Sanitizing products

Regulation Type: Regular notification

Distribution date: 11 May 2022 | Final date for Comment: 05 May 2025

This resolution contains provisions on bacteria-based sanitizing products, a result of the consolidation of previous regulations, without change of merit.This resolution incorporates into the national legal system the MERCOSUR/GMC Resolution number 63/14.

Products Covered: HS (3402) - Sanitizing products

Regulation Type: Regular notification

Distribution date: 11 May 2022 | Final date for Comment: 05 May 2025

This resolution contains provisions on the way of defining the Manufacturer Price (PF) and the Maximum Consumer Price (PMC) of medicines on 31 March 2022, establishes the form of presentation of the Marketing Report to the Medicines Market Regulation Chamber and regulates the advertising of pharmaceutical product prices.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 11 May 2022 | Final date for Comment: 05 May 2025

This resolution contains provisions on the way of defining the Manufacturer Price (PF) and the Maximum Consumer Price (PMC) of medicines on 31 March 2022, establishes the form of presentation of the Marketing Report to the Medicines Market Regulation Chamber and regulates the advertising of pharmaceutical product prices.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification