Regulatory Updates
Draft Normative Instruction number 931, 13 October 2020 Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=60163
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
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
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
DUS 2276:2020, Medical cotton swabs — Specification, First Edition
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
DUS 2257:2020, Refined Gold — Specification, First Edition
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
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
Proyecto de Primera Revisión del Reglamento Técnico Ecuatoriano PRTE INEN 251 (1R) "Perfiles, barras, varillas y tubos extruidos de aluminio" (Draft first revision (1R) of Ecuadorian Technical Regulation PRTE INEN No. 251, "Extruded aluminium profiles, bars, rods, tubes and pipes") (9 pages, in Spanish)
Distribution date: 29 October 2020 | Final date for Comment: 28 December 2020
The notified Ecuadorian Technical Regulation establishes the requirements to be met by extruded aluminium profiles, bars, rods, tubes and pipes primarily intended for architectural and structural applications, 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: Aluminium alloy profiles, bars, rods, tubes and pipes that are heat-treated or not heat-treated in accordance with their chemical composition, primarily intended for architectural and structural applications. Architectural. Refers to extruded profiles, bars, rods, tubes and pipes used in the construction industry, in decorative materials and for other related purposes. Structural. Refers to extruded profiles, bars, rods, tubes and pipes used in industrial structures and structures such as roofs, canopies and staircases.
Products Covered: Bars, rods and profiles, of aluminium, n.e.s. (HS code(s): 7604); Aluminium tubes and pipes (excl. hollow profiles) (HS code(s): 7608)
Regulation Type: Regular notification
Proyecto de Primera Revisión del Reglamento Técnico Ecuatoriano PRTE INEN 251 (1R) "Perfiles, barras, varillas y tubos extruidos de aluminio" (Draft first revision (1R) of Ecuadorian Technical Regulation PRTE INEN No. 251, "Extruded aluminium profiles, bars, rods, tubes and pipes") (9 pages, in Spanish)
Distribution date: 29 October 2020 | Final date for Comment: 28 December 2020
The notified Ecuadorian Technical Regulation establishes the requirements to be met by extruded aluminium profiles, bars, rods, tubes and pipes primarily intended for architectural and structural applications, 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: Aluminium alloy profiles, bars, rods, tubes and pipes that are heat-treated or not heat-treated in accordance with their chemical composition, primarily intended for architectural and structural applications. Architectural. Refers to extruded profiles, bars, rods, tubes and pipes used in the construction industry, in decorative materials and for other related purposes. Structural. Refers to extruded profiles, bars, rods, tubes and pipes used in industrial structures and structures such as roofs, canopies and staircases.
Products Covered: Bars, rods and profiles, of aluminium, n.e.s. (HS code(s): 7604); Aluminium tubes and pipes (excl. hollow profiles) (HS code(s): 7608)
Regulation Type: Regular notification
DUS DEAS 928-1:2018, Hot applied thermoplastic road marking paint — Specification, Part 1: Constituent material and mixtures, First Edition.
Distribution date: 28 October 2020
The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; DUS DEAS 928-1:2018, Hot applied thermoplastic road marking paint — Specification, Part 1: Constituent material and mixtures, First Edition; notified in G/TBT/N/UGA/997 entered into force on 4 September 2020. The Uganda Standard, US EAS 928-1:2019, Hot applied thermoplastic road marking paint — Specification, Part 1: Constituent material and mixtures, First Edition, can be purchased online through the link: https://webstore.unbs.go.ug/.
Products Covered: Thermoplastic road marking paint
Regulation Type: Addendum to Regular Notification
DUS DEAS 928-1:2018, Hot applied thermoplastic road marking paint — Specification, Part 1: Constituent material and mixtures, First Edition.
Distribution date: 28 October 2020
The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; DUS DEAS 928-1:2018, Hot applied thermoplastic road marking paint — Specification, Part 1: Constituent material and mixtures, First Edition; notified in G/TBT/N/UGA/997 entered into force on 4 September 2020. The Uganda Standard, US EAS 928-1:2019, Hot applied thermoplastic road marking paint — Specification, Part 1: Constituent material and mixtures, First Edition, can be purchased online through the link: https://webstore.unbs.go.ug/.
Products Covered: Thermoplastic road marking paint
Regulation Type: Addendum to Regular Notification
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