The Normative Instruction number 43, 21 August 2019 – previously notified through G/TBT/N/BRA/870/Add.10 – which adopts Complementary guidelines to the manufacture of pressurised metered dose aerosol preparations for inhalation of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was rectified. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Normative Instruction number 39, August 21st, 2019 – previously notified through G/TBT/N/BRA/870/Add.6 – which adopts Complementary guidelines to the manufacture of herbal medicinal products of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of July 1st, 2018, was republished. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Normative Instruction number 38, 21 August 2019 – previously notified through G/TBT/N/BRA/870/Add.5 – which adopts Complementary guidelines to the manufacture of medicinal gases of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was rectified. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Normative Instruction number 35, 21 August 2019 – previously notified through G/TBT/N/BRA/870/Add.2 – which adopts Complementary guidelines to the manufacture of sterile medicinal products of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was rectified. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Draft Resolution 736, 7 November 2019 – previously notified through G/TBT/N/BRA/940 – which establishes the topics for the changing of information presented in the process of market authorization of medical devices in ANVISA, was adopted as Normative Instruction 61, 6 March 2020. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020
Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)
Regulation Type: Addendum to Regular Notification
The Normative Instruction number 36, 21 August 2019 – previously notified through G/TBT/N/BRA/870/Add.3 – which adopts Complementary guidelines to the manufacture of biological medicinal substances and products for human use of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was rectified. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Resolution – RDC number 301, 21 August 2019 – previously notified through G/TBT/N/BRA/870/Add.1 – which adopts Good Practice Guidelines for the Manufacture of Medicines of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was republished. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Draft Resolution number 735, 7 November 2019 – previously notified through G/TBT/N/BRA/941 – which establishes criteria for the changing of information of medical devices after its market authorization and provides other measures, was adopted as Resolution – RDC number 340, 6 March 2020. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020
Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)
Regulation Type: Addendum to Regular Notification
The Draft Resolution number 710, 16 September 2019 – previously notified through G/TBT/N/BRA/915 – that proposes the revision of the Resolution – RDC number 4, 4 February 2011, which establishes the minimum requirements of identity and quality for transfusion, infusion and transfusion pumps sets for single use, was adopted as Resolution – RDC number 342, 6 March 2020. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 18 March 2020
Products Covered: HS Code(s): 30045020 (infusion sets for single use)
Regulation Type: Addendum to Regular Notification
Resolution – RDC number 346, March 12th, 2020
Distribution date: 18 March 2020
This Resolution establishes extraordinary and temporary criteria and procedure for Good Manufacture Practice Guidelines for market authorization and post-market registration amendments of Active Pharmaceutical Ingredients, medicines, and healthcare products due to the international public health emergency of the new coronavirus (Covid-19).
Products Covered: HS Code(s): 29, 2936, 2937, 2941, 30, 3001, 3002, 3003, 3004, 3005, 3006. (pharmaceutical products, active pharmaceutical ingredients, and healthcare products)
Regulation Type: Regular notification
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