Regulatory Updates

Draft Resolution number 932, 13 October 2020. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=60162

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Distribution date: 29 October 2020 | Final date for Comment: 28 December 2020

This draft resolution establishes criteria for the concession of market authorization for medicines with synthetic and semisynthetic active principles for human use categorized as new, innovative, generic, and similar.

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); 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: Regular notification

Human health

Draft Resolution number 932, 13 October 2020. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=60162

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Distribution date: 29 October 2020 | Final date for Comment: 28 December 2020

This draft resolution establishes criteria for the concession of market authorization for medicines with synthetic and semisynthetic active principles for human use categorized as new, innovative, generic, and similar.

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); 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: Regular notification

Human health

DUS 2275: 2020, Castor oil for cosmetic industry — Specification, First Edition

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Distribution date: 29 October 2020 | Final date for Comment: 28 December 2020

This Draft Uganda Standard specifies the requirements, sampling and test methods for castor oil for cosmetic industry

Products Covered: Castor oil for cosmetic industry

Regulation Type: Regular notification

DUS 2275: 2020, Castor oil for cosmetic industry — Specification, First Edition

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Distribution date: 29 October 2020 | Final date for Comment: 28 December 2020

This Draft Uganda Standard specifies the requirements, sampling and test methods for castor oil for cosmetic industry

Products Covered: Castor oil for cosmetic industry

Regulation Type: Regular notification

Draft Normative Instruction number 931, 13 October 2020 Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=60163

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Distribution date: 29 October 2020 | Final date for Comment: 28 December 2020

This draft normative instruction establishes new codes for the administrative request of market authorization for new and innovative synthetic and semisynthetic medicines.

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); 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: Regular notification

Draft Normative Instruction number 931, 13 October 2020 Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=60163

Product Image

Distribution date: 29 October 2020 | Final date for Comment: 28 December 2020

This draft normative instruction establishes new codes for the administrative request of market authorization for new and innovative synthetic and semisynthetic medicines.

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); 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: Regular notification

DUS 2276:2020, Medical cotton swabs — Specification, First Edition

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Distribution date: 29 October 2020 | Final date for Comment: 28 December 2020

This Draft Uganda Standard specifies requirements, sampling and methods of test for medical cotton swabs.

Products Covered: Medical cotton swabs

Regulation Type: Regular notification

Human health

DUS 2276:2020, Medical cotton swabs — Specification, First Edition

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Distribution date: 29 October 2020 | Final date for Comment: 28 December 2020

This Draft Uganda Standard specifies requirements, sampling and methods of test for medical cotton swabs.

Products Covered: Medical cotton swabs

Regulation Type: Regular notification

Human health

DUS 2257:2020, Refined Gold — Specification, First Edition

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Distribution date: 29 October 2020 | Final date for Comment: 28 December 2020

This Draft Uganda Standard specifies the requirements and methods of sampling and test for refined gold in cast bar form.

Products Covered: Refined Gold

Regulation Type: Regular notification

DUS 2257:2020, Refined Gold — Specification, First Edition

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Distribution date: 29 October 2020 | Final date for Comment: 28 December 2020

This Draft Uganda Standard specifies the requirements and methods of sampling and test for refined gold in cast bar form.

Products Covered: Refined Gold

Regulation Type: Regular notification

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