Resolution – RDC number 636, 24 March 2022

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Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025

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

Human health

Resolution – RDC number 636, 24 March 2022

Product Image

Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025

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

Human health

Resolution – RDC number 670, 30 March 2022

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Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025

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

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Human health

Resolution – RDC number 670, 30 March 2022

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Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025

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

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Human health

Normative Instruction number 128, 30 March 2022

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Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025

This normative instruction contains provisions on Good Manufacturing Practices complementary to Radiopharmaceuticals.

Products Covered: HS (3003-3004) - Medicaments 

Regulation Type: Regular notification

Human health

Normative Instruction number 128, 30 March 2022

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Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025

This normative instruction contains provisions on Good Manufacturing Practices complementary to Radiopharmaceuticals.

Products Covered: HS (3003-3004) - Medicaments 

Regulation Type: Regular notification

Human health

Extension of RDC No. 567, 29 September 2021.

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Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025

The Resolution number 567, 29 September 2021 - previously notified through G/TBT/N/BRA/910/Add.2 - which modified Normative Instruction number 81, 16 December 2020, was changed by Resolution - RDC number 674, 30 March 2022. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/legislacao#/visualizar/479717

Products Covered: HS CODE: 3006 (radiopharmaceuticals)

Regulation Type: Addendum to Regular Notification

Human health

Extension of RDC No. 567, 29 September 2021.

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Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025

The Resolution number 567, 29 September 2021 - previously notified through G/TBT/N/BRA/910/Add.2 - which modified Normative Instruction number 81, 16 December 2020, was changed by Resolution - RDC number 674, 30 March 2022. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/legislacao#/visualizar/479717

Products Covered: HS CODE: 3006 (radiopharmaceuticals)

Regulation Type: Addendum to Regular Notification

Human health

Normative Instruction number 124, 24 March 2022

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Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025

This normative instruction establishes the "List of assets allowed in cosmetic products to straighten or curl hair" with requirements for their use, under the terms of the Resolution – RDC number 409, 27 July 2020.

Products Covered: HS (3305) - Hair preparations; for use on the hair

Regulation Type: Regular notification

Human health

Normative Instruction number 124, 24 March 2022

Product Image

Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025

This normative instruction establishes the "List of assets allowed in cosmetic products to straighten or curl hair" with requirements for their use, under the terms of the Resolution – RDC number 409, 27 July 2020.

Products Covered: HS (3305) - Hair preparations; for use on the hair

Regulation Type: Regular notification

Human health

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