DUS 925:2021, Chemicals used for treatment of water intended for human use — Sodium hypochlorite — Specification, Second Edition

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Distribution date: 08 June 2021 | Final date for Comment: 07 August 2021

This Draft Uganda Standard specifies the requirements and methods of sampling and test for sodium hypochlorite solution used for disinfection of water intended for human use.

Products Covered: Sodium hypochlorite for water treatment

Regulation Type: Regular notification

DUS 2392:2021, Bath oils — Specification, First Edition

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Distribution date: 08 June 2021 | Final date for Comment: 07 August 2021

This Draft Uganda Standard specifies the requirements, sampling and test methods for bath oils based on refined vegetable oils or vegetable oils blends, mineral oils or mixture of the vegetable oils and mineral oils meant for application on the skin.

Products Covered: Bath oil

Regulation Type: Regular notification

Resolution – RDC No. 516, 2 June 2021. Amendment to Collegiate Board Resolution - RDC No. 483 of March 19, 2021

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Distribution date: 08 June 2021 | Final date for Comment: 13 May 2025

ANVISA Resolution number 483, 19 March 2021- previously notified through  G/TBT/N/BRA/1154 - which establishes exceptional and temporary technical requirements for the import of new medical devices and medicines identified as indispensable for the use in healthcare services due to the international public health emergency related to the SARS-CoV-2, was amended by Resolution – RDC  number 516, 2 June 2021.  

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis, incl. natural concentrates, derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent (HS code(s): 2936); Hormones, prostaglandins, thromboxanes and leukotrienes, natural or reproduced by synthesis; derivatives and structural analogues thereof "incl. chain modified polypeptides", used primarily as hormones (HS code(s): 2937); Antibiotics (HS code(s): 2941); PHARMACEUTICAL PRODUCTS (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

E09. COVID-19 TBT

Amendment of Resolution – RDC number 283, 17 May 2019

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Distribution date: 09 June 2021 | Final date for Comment: 13 May 2025

ANVISA Resolution RDC number 283, 4 May 2019, 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), - previously notified through G/TBT/N/BRA/871, was amended by the Resolution - RDC number 500, 27 May 2021.   The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/legislacao#/visualizar/451744

Products Covered: HS Codes: 2941; 30. (active pharmaceutical ingredients)

Regulation Type: Addendum to Regular Notification

Public Consultation No. 1.041, 8 April 2021

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Distribution date: 09 June 2021 | Final date for Comment: 30 June 2021

ANVISA Public Consultation No. 1041, 8 April 2021 - previously notified through G/TBT/N/BRA/1168 - which establishes criteria for granting or renewing GMP certification, was extended for 30 days. The extension period text is available only in Portuguese and can be downloaded at: https://www.in.gov.br/en/web/dou/-/despacho-n-66-de-27-de-maio-de-2021-323002535

Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)

Regulation Type: Addendum to Regular Notification

Establishment of the Japanese Pharmacopoeia Eighteenth edition

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Distribution date: 09 June 2021 | Final date for Comment: 13 May 2025

The draft revision to establish Japanese Pharmacopoeia, Eighteenth edition notified in G/TBT/N/JPN/677 has been adopted and published on dated 7 June 2021. Japanese Pharmacopoeia, Eighteenth edition in English is planned to be published in due course.

Products Covered: Pharmaceutical Products (HS:30)

Regulation Type: Addendum to Regular Notification

Draft Resolution No. 1050, 31 May 2021 Comment form: https://pesquisa.anvisa.gov.br/index.php/551215?lang=pt-BR

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Distribution date: 09 June 2021 | Final date for Comment: 08 July 2021

Draft resolution of risk assessment and control of potentially carcinogenic nitrosamines in medicines for human use.

Products Covered: 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 for transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Ready-mixed concrete - Compulsory requirements

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Distribution date: 10 June 2021 | Final date for Comment: 09 August 2021

This document applies to the production and supply of ready-mixed concrete for buildings and civil engineering structures cast in situ. The standard applies to ready-mixed concrete delivered to the purchaser in an unhardened, plastic state. This standard also outlines the mechanism to demonstrate compliance to these requirements and includes measures to be taken in the event of non-compliance. 

Products Covered: Non-refractory mortars and concretes (HS code(s): 382450); Concrete and concrete products (ICS code(s): 91.100.30)

Regulation Type: Regular notification

DUS 2139-1, Textiles — Underwear — Part 1: Boxer shorts — Specification (First edition)

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Distribution date: 14 June 2021 | Final date for Comment: 13 August 2021

This Draft Uganda Standard specifies requirements, sampling and test methods for men’s and boys’ boxer shorts 

Products Covered: Boxers

Regulation Type: Regular notification

DUS 2139-2, Textiles — Underwear — Part 2: Briefs — Specification (First edition)

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Distribution date: 14 June 2021 | Final date for Comment: 13 August 2021

This Draft Uganda Standard specifies requirements, sampling and test methods for briefs for men and women

Products Covered: (HS code(s): 6107, 6108); (ICS code(s): 61.020)

Regulation Type: Regular notification

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