Regulatory Updates

Resolution number 563, 15 September 2021.

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Distribution date: 06 July 2022

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Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); HEALTH CARE TECHNOLOGY (ICS code(s): 11)

Regulation Type: Addendum to Regular Notification

E09. COVID-19 TBT Human health

Resolution number 563, 15 September 2021.

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Distribution date: 06 July 2022

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Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); HEALTH CARE TECHNOLOGY (ICS code(s): 11)

Regulation Type: Addendum to Regular Notification

E09. COVID-19 TBT Human health

Implementation of Abridged and Verification Review Pathways for New Drug, Initial Registration and Post-Approval Changes Applications of Drug Products, including Vaccines and Biologicals

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Distribution date: 01 July 2022

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Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Human health E09. COVID-19 TBT

Implementation of Abridged and Verification Review Pathways for New Drug, Initial Registration and Post-Approval Changes Applications of Drug Products, including Vaccines and Biologicals

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Distribution date: 01 July 2022

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Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Human health E09. COVID-19 TBT

DUS 2536:2022, Standard Test Method for Analysis of Natural Gas by Gas Chromatography , First Edition

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Distribution date: 01 July 2022 | Final date for Comment: 30 August 2022

This Draft Uganda covers the determination of the chemical composition of natural gases and similar gaseous mixtures . This test method may be abbreviated for the analysis of lean natural gases containing negligible amounts of hexanes and higher hydrocarbons, or for the determination of one or more components, as required.

Products Covered: Petroleum gases and other gaseous hydrocarbons. (HS code(s): 2711); Fuels (ICS code(s): 75.160)

Regulation Type: Regular notification

DUS 2536:2022, Standard Test Method for Analysis of Natural Gas by Gas Chromatography , First Edition

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Distribution date: 01 July 2022 | Final date for Comment: 30 August 2022

This Draft Uganda covers the determination of the chemical composition of natural gases and similar gaseous mixtures . This test method may be abbreviated for the analysis of lean natural gases containing negligible amounts of hexanes and higher hydrocarbons, or for the determination of one or more components, as required.

Products Covered: Petroleum gases and other gaseous hydrocarbons. (HS code(s): 2711); Fuels (ICS code(s): 75.160)

Regulation Type: Regular notification

Draft Amendments to  the Regulations for the Inspection and Examination of Imported Medical Devices 

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Distribution date: 30 June 2022

To respond to the new coronavirus pandemic and to ensure the quality of medical devices for protecting the safety and well-being of the public, the Food and Drug Administration proposes to conduct inspection and examination for imported COVID-19 Antigen  Home/Self Tests.

Products Covered: COVID-19 Antigen  Home/Self Test (HS code(s): 3002)

Regulation Type: Regular notification

E09. COVID-19 TBT Human health

Draft Amendments to  the Regulations for the Inspection and Examination of Imported Medical Devices 

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Distribution date: 30 June 2022

To respond to the new coronavirus pandemic and to ensure the quality of medical devices for protecting the safety and well-being of the public, the Food and Drug Administration proposes to conduct inspection and examination for imported COVID-19 Antigen  Home/Self Tests.

Products Covered: COVID-19 Antigen  Home/Self Test (HS code(s): 3002)

Regulation Type: Regular notification

E09. COVID-19 TBT Human health

DUS 1659: 2022, Materials in contact with food — Requirements for packaging materials, Second Edition

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Distribution date: 29 June 2022 | Final date for Comment: 28 August 2022

This Draft Uganda Standard provides requirements for food contact surfaces including packaging materials that are intended for that purpose and can be expected to come into contact with food under normal or foreseeable conditions of use." The standard does not include coverings or coatings and substances that are part of the food and may be eaten with it such as sausage skin for which other standards apply. Note: This Draft Uganda Standard was also notified to the TBT Committee.

Products Covered: Plastics and articles thereof (HS code(s): 39); Packaging materials and accessories (ICS code(s): 55.040)

Regulation Type: Revision to Regular Notification

Packaging Food safety Human health Contaminants

DUS 1659: 2022, Materials in contact with food — Requirements for packaging materials, Second Edition

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Distribution date: 29 June 2022 | Final date for Comment: 28 August 2022

This Draft Uganda Standard provides requirements for food contact surfaces including packaging materials that are intended for that purpose and can be expected to come into contact with food under normal or foreseeable conditions of use." The standard does not include coverings or coatings and substances that are part of the food and may be eaten with it such as sausage skin for which other standards apply. Note: This Draft Uganda Standard was also notified to the TBT Committee.

Products Covered: Plastics and articles thereof (HS code(s): 39); Packaging materials and accessories (ICS code(s): 55.040)

Regulation Type: Revision to Regular Notification

Packaging Food safety Human health Contaminants

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