Resolution – RDC number 494, 15 April 2021

Distribution date: 27 April 2021 | Final date for Comment: 13 May 2025
ANVISA issued RDC No. 494, 15 April 2021, that amends the Collegiate Board Resolution - RDC No. 283, of 17 May 2019, previously notified through G/TBT/N/BRA/871, which establishes technical requirements for investigation, control and elimination of nitrosamines potentially carcinogenic in active pharmaceutical ingredients (IFA) which are angiotensin II receptor antagonists; and is applied to companies that manufacture, import and fractionate active pharmaceutical ingredients (IFA). The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6260694/RDC_494_2021_.pdf/00d1e534-238d-46e8-a3a8-d225aff673f3
Products Covered: HS Codes: 2941; 30. (active pharmaceutical ingredients)
Regulation Type: Addendum to Regular Notification
Public Consultation No. 1043, 8 April 2021. Draft: http://antigo.anvisa.gov.br/documents/10181/4859043/Minuta+de+CP.pdf/39d90f00-e9e7-4619-adbe-75ff38ec0cd6 Comment form: https://pesquisa.anvisa.gov.br/index.php/447285?lang=pt-BR

Distribution date: 27 April 2021 | Final date for Comment: 14 May 2021
Public Consultation Proposal to establish technical requirements for the import, commercialization, and donation of used reprocessed medical devices.
Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)
Regulation Type: Regular notification
Public Consultation No. 1037, 8 April 2021. Draft: http://antigo.anvisa.gov.br/documents/10181/3445713/Minuta+1037.pdf/6e666574-b2fd-4762-9bec-9a1104bada72 Comment form: https://pesquisa.anvisa.gov.br/index.php/417326?lang=pt-BR

Distribution date: 27 April 2021 | Final date for Comment: 15 June 2021
Public Consultation proposal to establish technical requirements for research on pesticides residues and establishment of Maximum Residue Limits for the purpose of market authorization for pesticides in Brazil.
Products Covered: HS Code(s): 38089910 (pesticides)
Regulation Type: Regular notification
Public Consultation No. 1042, 8 April 2021. Draft: http://antigo.anvisa.gov.br/documents/10181/6254098/Minuta+1042.pdf/67d15531-b822-46ec-97a3-a3c936e69c12 Comment form: https://pesquisa.anvisa.gov.br/index.php/934179?lang=pt-BR

Distribution date: 27 April 2021 | Final date for Comment: 15 June 2021
Public Consultation proposal to establish technical requirements for the classification of orthopaedic implantable materials for the purpose of market authorization.
Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)
Regulation Type: Regular notification
DUS 2127:2019, Food grade gelatin – Specification, First Edition

Distribution date: 28 April 2021 | Final date for Comment: 13 May 2025
The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; DUS 2127:2019, Food grade gelatin – Specification, First Edition; notified in G/TBT/N/UGA/1028 and G/TBT/N/UGA/1028/Add.1 entered into force on 7 November 2020. The Uganda Standard, US 2127:2019, Food grade gelatin – Specification, First Edition, can be purchased online through the link: https://webstore.unbs.go.ug/
Products Covered: Gelatin, whether or not in square or rectangular sheets, whether or not surface-worked or coloured, and gelatin derivatives; isinglass; other glues of animal origin (excl. those packaged as glue for retail sale and weighing
Regulation Type: Addendum to Regular Notification
DUS 2035:2018, Steviol glycosides – Specification, First Edition

Distribution date: 28 April 2021 | Final date for Comment: 13 May 2025
The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; DUS 2035:2018, Steviol glycosides – Specification, First Edition; notified in G/TBT/N/UGA/1011 and G/TBT/N/UGA/1011/Add.1 entered into force on 7 November 2020. The Uganda Standard, US 2035:2019, Steviol glycosides – Specification, First Edition, can be purchased online through the link: https://webstore.unbs.go.ug/
Products Covered: Steviol glycosides
Regulation Type: Addendum to Regular Notification
National Standard of the P.R.C., Firestop Material

Distribution date: 28 April 2021 | Final date for Comment: 27 June 2021
This standard specifies terms and definitions, classification and labelling, requirements, test methods, inspection rules, comprehensive judging rules, marking, packaging, storage and transport of firestop material. This standard is applicable to firestop materials or firestop components used in various penetration holes and structural gaps in buildings, structures and various facilities.
Products Covered: Firestop Material
Regulation Type: Regular notification
Notice of Intent to Amend: Prescription Drug List (PDL): Metamizole (Dipyrone) (1 page, available in English and French)

Distribution date: 28 April 2021 | Final date for Comment: 07 July 2021
The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to add metamizole (also known as “dipyrone”) to the Prescription Drug List (PDL). Only the Veterinary part of the PDL is proposed to be revised.
Products Covered: Prescription status of medicinal ingredients for veterinary use
Regulation Type: Regular notification
DUS 2036: 2019, Food grade nitrogen – Specification, First Edition.

Distribution date: 28 April 2021 | Final date for Comment: 13 May 2025
The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; DUS 2036:2019, Food grade nitrogen – Specification, First Edition; notified in G/TBT/N/UGA/1027 and G/TBT/N/UGA/1027/Add.1 entered into force on 7 November 2020. The Uganda Standard, US 2036:2019, Food grade nitrogen – Specification, First Edition, can be purchased online through the link: https://webstore.unbs.go.ug/
Products Covered: Food grade nitrogen
Regulation Type: Addendum to Regular Notification
DUS 365: 2018, Powdered (icing) sugar — Specification, Second Edition

Distribution date: 29 April 2021 | Final date for Comment: 13 May 2025
The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; DUS 365: 2018, Powdered (icing) sugar — Specification, Second Edition; notified in G/TBT/N/UGA/918 and G/TBT/N/UGA/918/Add.1 entered into force on 7 November 2020. The Uganda Standard, US 365:2019, Powdered (icing) sugar — Specification, Second Edition, can be purchased online through the link: https://webstore.unbs.go.ug/
Products Covered: Icing sugar
Regulation Type: Addendum to Regular Notification
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