Regulatory Updates
Revision of the administrative rule of the Official Standards for Fertilizers
Distribution date: 19 March 2020 | Final date for Comment: 18 April 2020
Considering technical advancement and needs for complex fertilizers, the MAFF will revise the administrative rule of the Official standards for fertilizer in order to achieve the progress and sustainability of agricultural productivity and to protect human health. The following agricultural chemicals will be permitted to add a fertilizer as the official standards (Annex 1). (RS)-1-methyl-2-nitro-3-(tetrahydro-3-furylmethyl)guanidine potassium(R)-2-(4-chloro-o-tolyloxy)propionate and 2,6-dichlorobenzonitrile
Products Covered: Fertilizer (HS: 3102, 3103, 3104, 3105)
Regulation Type: Regular notification
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
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