Regulatory Updates
The notification G/TBT/N/BRA/1313 was circulated erroneously and should therefore be considered null and void since the Normative Instruction number 19, 23 February 2022, was already notified through the notification G/TBT/N/BRA/1310.
Distribution date: 12 April 2022
Products Covered: Medical Devices (HS 3006)
Regulation Type: Corrigendum to Regular Notification
Normative Instruction number 134, 30 March 2022
Distribution date: 12 April 2022
This normative instruction contains provisions on Good Manufacturing Practices complementary to the computerized systems used in the manufacture of medicines.
Products Covered: HS (3003-3004) - Medicaments
Regulation Type: Regular notification
Normative Instruction number 134, 30 March 2022
Distribution date: 12 April 2022
This normative instruction contains provisions on Good Manufacturing Practices complementary to the computerized systems used in the manufacture of medicines.
Products Covered: HS (3003-3004) - Medicaments
Regulation Type: Regular notification
Normative Instruction number 123, 24 March 2022
Distribution date: 12 April 2022
This normative instruction approves the Inspection Roadmap for Medicines Bioavailability/Bioequivalence Centers.
Products Covered: HS (3003-3004) - Medicaments
Regulation Type: Regular notification
Normative Instruction number 123, 24 March 2022
Distribution date: 12 April 2022
This normative instruction approves the Inspection Roadmap for Medicines Bioavailability/Bioequivalence Centers.
Products Covered: HS (3003-3004) - Medicaments
Regulation Type: Regular notification
Normative Instruction number 124, 24 March 2022
Distribution date: 12 April 2022
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
Normative Instruction number 124, 24 March 2022
Distribution date: 12 April 2022
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
Extension of RDC No. 567, 29 September 2021.
Distribution date: 12 April 2022
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
Extension of RDC No. 567, 29 September 2021.
Distribution date: 12 April 2022
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
Normative Instruction number 128, 30 March 2022
Distribution date: 12 April 2022
This normative instruction contains provisions on Good Manufacturing Practices complementary to Radiopharmaceuticals.
Products Covered: HS (3003-3004) - Medicaments
Regulation Type: Regular notification
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