Distribution date: 19 December 2022 | Final date for Comment: 05 May 2025

The Draft Resolution no. 815, 01 June 2020 - previously notified through G/TBT/N/BRA/1024 - which establishes technical requirements for the labelling of medicines, was adopted as the Resolution - RDC number 768, 12 December 2022. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/3426875/RDC_768_2022_.pdf/dbe15026-544d-42f1-8792-09658b8c8fda   

Products Covered: Antibiotics (HS code(s): 2941); 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 in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 19 December 2022 | Final date for Comment: 05 May 2025

The Draft Resolution number 989, 15 December 2020  - previously notified through G/TBT/N/BRA/1118 - which establishes technical requirements for the development, harmonization, updating, publication, and provision of medicine leaflets to patients andhealthcare professionals, was adopted as Resolution - RDC number 769, 12 December 2022. The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/6165008/RDC_769_2022_.pdf/f2ae47ac-dd5b-42c4-9d64-875315028dda 

Products Covered: Antibiotics (HS code(s): 2941); 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 in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005); Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 19 December 2022 | Final date for Comment: 05 May 2025

The RDC Nº 205, 28 December 2017 - previously notified through G/TBT/N/BRA/784 - which establishes special procedure for approval of clinical trials, good manufacturing practices certification and registration of new medicines for treatment, diagnosis or prevention of rare diseases, was changed by Resolution - Resolution - RDC number 763, 25 November 2022   The Resolution - RDC 763, 25 November 2022, was republished on 02 December 2022.The republished text is available only in Portuguese and can be downloaded at:https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-763-de-25-de-novembro-de-2022-*-447341166  

Products Covered: 3003 3004: Medicaments

Regulation Type: Addendum to Regular Notification

Distribution date: 19 December 2022 | Final date for Comment: 05 May 2025

The Draft Normative Instruction no. 816, 01 June 2020 - previously notified through G/TBT/N/BRA/1030 - which establishes technical requirements for labelling of large-volume parenteral solutions, solutions for irrigation, dialysis, plasma expanders and small -volume parenteral solutions, was adopted as the Normative Instruction number 198, 12 December 2022. The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/3426875/IN_198_2022_.pdf/09bd721e-07af-4305-b817-08165295581f 

Products Covered: HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).

Regulation Type: Addendum to Regular Notification

Distribution date: 19 December 2022 | Final date for Comment: 05 May 2025

The Draft Resolution no. 817, 01 June 2020 - previously notified through G/TBT/N/BRA/1031 - which establishes warning phrases for substances and or therapeutic classes in leaflets and packaging of medicines, was adopted as  the Normative Instruction number 200, 12 December 2022, and the Resolution - RDC number 770, 12 December 2022. The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/3426605/IN_200_2022_.pdf/d242f446-f9b6-437a-b61b-a5dd7a09d5f2http://antigo.anvisa.gov.br/documents/10181/3426605/RDC_770_2022_.pdf/c4426480-d1a5-426a-9433-d345114f018e  

Products Covered: HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).

Regulation Type: Addendum to Regular Notification

Distribution date: 20 December 2022 | Final date for Comment: 18 February 2023

This draft East African Standard specifies the requirements sampling and test methods for soya protein products intended for human consumption

Products Covered: Peptones and their derivatives; other protein substances and their derivatives, n.e.s.; hide powder, whether or not chromed (excl. organic or inorganic compounds of mercury whether or not chemically defined) (HS code(s): 3504); Cereals, pulses and derived products (ICS code(s): 67.060)

Regulation Type: Regular notification

Distribution date: 20 December 2022 | Final date for Comment: 05 May 2025

The aim of this addendum is to inform WTO Members that the Draft Tanzania Standard; TBS/CDC-2(5795) P3 Household laundry detergent bars – Specification notified in G/TBT/N/TZA/314 entered into force on 1 April 2022 as Tanzania Standard, TZS 2593:2021 Household laundry detergent bars - Specification. This specification can be purchased by contacting the TBT NEP through [email protected]

Products Covered: (HS code(s): 340290); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Addendum to Regular Notification

Distribution date: 20 December 2022 | Final date for Comment: 05 May 2025

The aim of this addendum is to inform WTO Members that the Draft East Africa  Standard; DEAS 906:2018 Fertilizer ― Triple Superphosphate ― Specification. notified in G/TBT/N/TZA/52/Rev.1 entered into force on 1 July  2022 as Tanzania Standard, TZS 157:2021/EAS 906:2019 Fertilizers — Triple Superphosphate — Specification. This specification can be purchased by contacting the TBT NEP through [email protected]

Products Covered: (HS code(s): 31); Fertilizers (ICS code(s): 65.080)

Regulation Type: Addendum to Regular Notification

Distribution date: 20 December 2022 | Final date for Comment: 18 February 2023

This draft East African Standard specifies the requirements sampling and test methods for soya protein products intended for human consumption

Products Covered: Peptones and their derivatives; other protein substances and their derivatives, n.e.s.; hide powder, whether or not chromed (excl. organic or inorganic compounds of mercury whether or not chemically defined) (HS code(s): 3504); Cereals, pulses and derived products (ICS code(s): 67.060)

Regulation Type: Regular notification

Distribution date: 20 December 2022 | Final date for Comment: 18 February 2023

This draft East African Standard specifies the requirements sampling and test methods for soya protein products intended for human consumption

Products Covered: Peptones and their derivatives; other protein substances and their derivatives, n.e.s.; hide powder, whether or not chromed (excl. organic or inorganic compounds of mercury whether or not chemically defined) (HS code(s): 3504); Cereals, pulses and derived products (ICS code(s): 67.060)

Regulation Type: Regular notification