Regulatory Updates

Distribution date: 06 January 2021 | Final date for Comment: 07 March 2021

The amendment to the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices was established in December 2019. The amendment to the Act introduced the system in Japan according to which Marketing Authorization Holders (MAHs) basically use electronic methods such as barcodes when providing information on pharmaceuticals and medical devices. The Ordinance for Enforcement of the Act will be amended to specify the details of the system.

Products Covered: (HS code(s): 30, 90); (ICS code(s): 11.040, 11.120)

Regulation Type: Regular notification

Distribution date: 06 January 2021

The aim of this addendum is to inform WTO Members that the Uganda Standard; US 1877:2019, Deodorants and antiperspirants — Specification; notified in G/TBT/N/UGA/779, G/TBT/N/UGA/779/Add.1 and G/TBT/N/UGA/779/Add.2 was withdrawn on 15 December 2020.

Products Covered: Shaving preparations, incl. pre-shave and after-shave products, personal deodorants, bath and shower preparations, depilatories and other perfumery, toilet or cosmetic preparations, n.e.s.; prepared room deodorizers, whether or not perfumed or having disinfectant properties (HS code(s): 3307); Personal deodorants and antiperspirants (HS code(s): 330720); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Addendum to Regular Notification

Distribution date: 06 January 2021

The aim of this addendum is to inform WTO Members that the Uganda Standard; US 1877:2019, Deodorants and antiperspirants — Specification; notified in G/TBT/N/UGA/779, G/TBT/N/UGA/779/Add.1 and G/TBT/N/UGA/779/Add.2 was withdrawn on 15 December 2020.

Products Covered: Shaving preparations, incl. pre-shave and after-shave products, personal deodorants, bath and shower preparations, depilatories and other perfumery, toilet or cosmetic preparations, n.e.s.; prepared room deodorizers, whether or not perfumed or having disinfectant properties (HS code(s): 3307); Personal deodorants and antiperspirants (HS code(s): 330720); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Addendum to Regular Notification

Distribution date: 06 January 2021

The aim of this addendum is to inform WTO Members that the Uganda Standard; US 1932:2019, Lip balm (salve) — Specification; notified in G/TBT/N/UGA/800, G/TBT/N/UGA/800/Add.1 and G/TBT/N/UGA/800/Add.2 was withdrawn on 15 December 2020.

Products Covered: Lip balm, Lip salve.

Regulation Type: Addendum to Regular Notification

Distribution date: 06 January 2021

The aim of this addendum is to inform WTO Members that the Uganda Standard; US 1932:2019, Lip balm (salve) — Specification; notified in G/TBT/N/UGA/800, G/TBT/N/UGA/800/Add.1 and G/TBT/N/UGA/800/Add.2 was withdrawn on 15 December 2020.

Products Covered: Lip balm, Lip salve.

Regulation Type: Addendum to Regular Notification

Distribution date: 06 January 2021 | Final date for Comment: 07 March 2021

The Therapeutic Goods Administration (TGA) is proposing to update the regulation of medicinal cannabis labelling and packaging. The proposal reform seeks to: provide clarity to the stated content of active ingredients and establish new labelling requirements introduce a requirement for child-resistant closures in the interest of public safety The update to the standard is not intended to impose significant regulatory burden or create barriers to supply cannabis goods in Australia. A public consultation on the draft changes to the standard is currently open and closed on 29th January 2021. The consultation documents are available via the link provided below. The TGA will review all the submissions received and will make changes to the draft standard and associated guidance in consideration of this feedback. It is planned that there will be a transition period to allow sufficient time for suppliers of medicinal cannabis products to comply with any updates to the standard.

Products Covered: Medicines

Regulation Type: Regular notification

Distribution date: 06 January 2021 | Final date for Comment: 07 March 2021

The Therapeutic Goods Administration (TGA) is proposing to update the regulation of medicinal cannabis labelling and packaging. The proposal reform seeks to: provide clarity to the stated content of active ingredients and establish new labelling requirements introduce a requirement for child-resistant closures in the interest of public safety The update to the standard is not intended to impose significant regulatory burden or create barriers to supply cannabis goods in Australia. A public consultation on the draft changes to the standard is currently open and closed on 29th January 2021. The consultation documents are available via the link provided below. The TGA will review all the submissions received and will make changes to the draft standard and associated guidance in consideration of this feedback. It is planned that there will be a transition period to allow sufficient time for suppliers of medicinal cannabis products to comply with any updates to the standard.

Products Covered: Medicines

Regulation Type: Regular notification

Distribution date: 06 January 2021

The aim of this addendum is to inform WTO Members that the Uganda Standard; US 1931:2019, Shea butter for Cosmetic industry — Specification; notified in G/TBT/N/UGA/799, G/TBT/N/UGA/799/Add.1 and G/TBT/N/UGA/799/Add.2 was withdrawn on 15 December 2020.

Products Covered: Shea butter.

Regulation Type: Addendum to Regular Notification

Distribution date: 06 January 2021

The aim of this addendum is to inform WTO Members that the Uganda Standard; US 1931:2019, Shea butter for Cosmetic industry — Specification; notified in G/TBT/N/UGA/799, G/TBT/N/UGA/799/Add.1 and G/TBT/N/UGA/799/Add.2 was withdrawn on 15 December 2020.

Products Covered: Shea butter.

Regulation Type: Addendum to Regular Notification

Distribution date: 06 January 2021

The aim of this addendum is to inform WTO Members that the Uganda Standard; US 1832:2019, Glycerine for Cosmetic use — Specification; notified in G/TBT/N/UGA/754, G/TBT/N/UGA/754/Add.1 and G/TBT/N/UGA/754/Add.2 was withdrawn on 15 December 2020.

Products Covered: Glycerol (HS code(s): 290545); Inorganic chemicals (ICS code(s): 71.060); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Addendum to Regular Notification