Distribution date: 30 October 2020

Resolution – RDC number 423, 16 September 2020 – previously notified through G/TBT/N/BRA/1081– which changes the Resolution – RDC number 27, 21 June 2011, the Resolution – RDC number 36, 26 August 2015, and the Resolution – RDC number 40, 26 August 2015; and establishes the cancellation of the registration system for medical devices classified as Class Risk I and II, which must be registered in the notification regime was republished. 

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent. (HS code(s): 2936); Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones. (HS code(s): 2937); Pharmaceutical products (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 30 October 2020

Resolution – RDC number 423, 16 September 2020 – previously notified through G/TBT/N/BRA/1081– which changes the Resolution – RDC number 27, 21 June 2011, the Resolution – RDC number 36, 26 August 2015, and the Resolution – RDC number 40, 26 August 2015; and establishes the cancellation of the registration system for medical devices classified as Class Risk I and II, which must be registered in the notification regime was republished. 

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent. (HS code(s): 2936); Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones. (HS code(s): 2937); Pharmaceutical products (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

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

The notified Ecuadorian Technical Regulation establishes the requirements to be met by non-petroleum-based brake fluids used in road-vehicle hydraulic brake and clutch systems, prior to the marketing of domestic and imported products, with the aim of protecting human safety and preventing deceptive practices. It applies to the following products: Non-petroleum-based brake fluids for hydraulic systems of the following classes: · Class 3 · Class 4 · Class 5-1 · Class 6 It does not apply to: · Petroleum-based brake fluids. · Silicone-based brake fluids.

Products Covered: Hydraulic brake fluids and other prepared liquids for hydraulic transmission not containing petroleum oil or bituminous mineral oil, or containing < 70% petroleum oil or bituminous mineral oil by weight (HS code(s): 3819); Braking systems (ICS code(s): 43.040.40)

Regulation Type: Revision to Regular Notification

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

The notified Ecuadorian Technical Regulation establishes the requirements to be met by non-petroleum-based brake fluids used in road-vehicle hydraulic brake and clutch systems, prior to the marketing of domestic and imported products, with the aim of protecting human safety and preventing deceptive practices. It applies to the following products: Non-petroleum-based brake fluids for hydraulic systems of the following classes: · Class 3 · Class 4 · Class 5-1 · Class 6 It does not apply to: · Petroleum-based brake fluids. · Silicone-based brake fluids.

Products Covered: Hydraulic brake fluids and other prepared liquids for hydraulic transmission not containing petroleum oil or bituminous mineral oil, or containing < 70% petroleum oil or bituminous mineral oil by weight (HS code(s): 3819); Braking systems (ICS code(s): 43.040.40)

Regulation Type: Revision to Regular Notification

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

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

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

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

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

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