Regulatory Updates

Draft Normative Instruction no. 816, 01 June 2020

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Distribution date: 29 June 2020 | Final date for Comment: 07 September 2020

This draft resolution establishes technical requirements for labelling of large-volume parenteral solutions, solutions for irrigation, dialysis, plasma expanders and small-volume parenteral solutions.

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

Regulation Type: Regular notification

Labelling

DUS 624:2020, Chrome-tanned bend outer sole leather — Specification, Second Edition.

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Distribution date: 29 June 2020 | Final date for Comment: 28 August 2020

This draft Uganda standard specifies requirements, sampling and test methods for chrome tanned, wax impregnated bend outer sole leather.

Products Covered: Sole leather

Regulation Type: Regular notification

DUS 630:2020, Vegetable-tanned bend outer sole leather — Specification, Second Edition.

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Distribution date: 29 June 2020 | Final date for Comment: 28 August 2020

This draft Uganda standard specifies requirements, sampling and methods of test for vegetable-tanned bend outer sole leather.

Products Covered: Sole leather

Regulation Type: Regular notification

DUS 624:2020, Chrome-tanned bend outer sole leather — Specification, Second Edition.

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Distribution date: 29 June 2020 | Final date for Comment: 28 August 2020

This draft Uganda standard specifies requirements, sampling and test methods for chrome tanned, wax impregnated bend outer sole leather.

Products Covered: Sole leather

Regulation Type: Regular notification

Draft Resolution no. 815, 01 June 2020

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Distribution date: 26 June 2020 | Final date for Comment: 07 September 2020

This draft resolution establishes technical requirements for the labelling of medicines.

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: Regular notification

Labelling

Draft Resolution no. 815, 01 June 2020

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Distribution date: 26 June 2020 | Final date for Comment: 07 September 2020

This draft resolution establishes technical requirements for the labelling of medicines.

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: Regular notification

Labelling

Draft Resolution no. 823, 12 June 2020

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Distribution date: 26 June 2020 | Final date for Comment: 21 July 2020

This draft resolution establishes technical requirements for the inclusion and updating of notification and market authorization form, product image, instructions for use and labelling in the process of regularization of medical devices.

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

Regulation Type: Regular notification

Draft Resolution no. 823, 12 June 2020

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Distribution date: 26 June 2020 | Final date for Comment: 21 July 2020

This draft resolution establishes technical requirements for the inclusion and updating of notification and market authorization form, product image, instructions for use and labelling in the process of regularization of medical devices.

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

Regulation Type: Regular notification

Draft Resolution no. 818, 01 June 2020

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Distribution date: 26 June 2020 | Final date for Comment: 07 September 2020

This draft resolution proposes the revision of Resolution – RDC no. 199, 26 October 2006, which establishes the simplified notification of medicines through electronic submitting.

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: Regular notification

Draft Resolution no. 818, 01 June 2020

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Distribution date: 26 June 2020 | Final date for Comment: 07 September 2020

This draft resolution proposes the revision of Resolution – RDC no. 199, 26 October 2006, which establishes the simplified notification of medicines through electronic submitting.

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: Regular notification

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