Regulatory Updates

Distribution date: 03 March 2021

This resolution establishes criteria for prescription, exemption, control, packaging, and labelling of medicines based on substances categorized as antimicrobial for use under prescription, isolated or associated. They will be listed in a specific Normative Instruction.

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 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: 03 March 2021 | Final date for Comment: 16 March 2021

The comment period is being extended till 16 March 2021, following request from Members.

Products Covered: All tobacco and manufactured tobacco substitutes, including but not limited to HS codes starting with, 2402 and 2403 and nicotine delivery systems, including components of such systems, including but not limited to HS codes starting with 2403, 3824 and 8543.

Regulation Type: Addendum to Regular Notification

Distribution date: 01 March 2021 | Final date for Comment: 30 April 2021

This standard specifies the technical requirements, sampling, test methods, inspection rules, and labelling, packaging, transportation, storage and shelf-life requirements of feed additive natural xanthophyll (saponified marigold extract). This document applies to the feed additive natural xanthophyll prepared by saponification of marigold extract, and its main coloring substances are lutein and zeaxanthin.

Products Covered: Feed Additive Natural Xanthophyll (Saponified Marigold Extract)

Regulation Type: Regular notification

Distribution date: 01 March 2021 | Final date for Comment: 30 April 2021

This standard specifies the requirements, sampling, test methods, inspection rules, and labelling, packaging, transportation, storage and shelf-life requirements of feed additive lactic acid. This document applies to the feed additive lactic acid with L-lactic acid as its main components, prepared by fermentation method with starch or sugar as raw materials.

Products Covered: Feed Additive—Lactic Acid

Regulation Type: Regular notification

Distribution date: 01 March 2021 | Final date for Comment: 30 April 2021

The Therapeutic Goods Administration (TGA) is seeking comments on a proposed standard for vaporiser nicotine products. Vaporiser nicotine products are nicotine-containing products intended to be used in vaping devices such as e-cigarettes, e-cigars and other electronic nicotine delivery systems (ENDs). This includes vape liquids, e-liquids and e-juices that contain nicotine and/or nicotine salts. This does not include other nicotine replacement therapies (NRTs) containing nicotine, such as patches, gum, lozenges, mouth spray and inhalators nor nicotine-containing products that are not intended for use in ENDs, such as chewing tobacco and snuff. The proposed standard relates only to unapproved goods – that is, medicines that have not been approved by the TGA and are not registered in the Australian Register of Therapeutic Goods (ARTG). While it is anticipated that a number of vaporiser nicotine products may seek approval by the TGA as medicines in the coming years, it is also anticipated that there will be a significant number of prescriptions written for unapproved goods for smoking cessation. The proposed standard is in the form of a Therapeutic Goods Order (a TGO) and would be TGO 110. TGOs are legal standards made under section 10 of the Therapeutic Goods Act 1989 (Act) which specify safety and quality rules for medicines imported into, exported from or supplied in Australia. TGOs can apply to approved or unapproved products, or both, and may be limited to a certain type of medicine. TGOs cannot specify requirements for vaping devices. The public consultation on the Therapeutic Goods (Standard for Vaporiser Nicotine) (TGO 110) Order 2021 (draft TGO 110) is open until 31 March 2021, available via the link in section 8 below. We will review all feedback received and, if appropriate, revise the requirements in the draft TGO 110 before it is finalised. 

Products Covered: Nicotine-containing products intended to be used in vaping devices such as e-cigarettes, e-cigars and other electronic nicotine delivery systems (ENDs).

Regulation Type: Regular notification

Distribution date: 01 March 2021

The Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan reports an outbreak of highly pathogenic avian influenza in the territory of the South Bohemian region of the Czech Republic. In this regard, since 2 February 2021 temporary restrictions have been introduced on the importation into the territory of Kazakhstan from the South Bohemian region of the Czech Republic, as well as transit from this territory through the territory of Kazakhstan of live poultry, hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment (not less than 70°C), feed and feed additives for birds (with the exception of feed additives of chemical and microbiological synthesis), trophies of the chase that have not undergone taxidermy treatment (feather game), as well as used equipment for keeping, slaughtering and cutting birds.

Products Covered: Live poultry, hatching eggs, down and feathers, poultry meat and all poultry products, fodder and feed additives for birds, trophies of the chase, used for the maintenance, slaughter and cutting of birds

Regulation Type: Emergency notifications (SPS)

Distribution date: 01 March 2021

The Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan reports an outbreak of highly pathogenic avian influenza in the territory of the Kiyev and Kheron regions of Ukraine. In this regard, since 9 January 2021 temporary restrictions have been introduced on the importation and transit through the territory of Kazakhstan from the territories of the Kiyev and Kheron regions, Ukraine, of live poultry, hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment (not less than 70°C), feed and feed additives for birds (with the exception of feed additives of chemical and microbiological synthesis), trophies of the chase that have not undergone taxidermy treatment (feather game), as well as used equipment for keeping, slaughtering and cutting birds.

Products Covered: Live poultry, hatching eggs, down and feathers, poultry meat and all poultry products, feed and feed additives for birds, trophies of the chase, used equipment for the keeping, slaughter and cutting of birds

Regulation Type: Emergency notifications (SPS)

Distribution date: 24 February 2021

The Draft Resolution number 967, 1 December 2020 - previously notified through G/SPS/N/BRA/1848 - was adopted as Resolution - RE number 528, 4 February 2021. The full text is available only in Portuguese and can be downloaded at:https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=08/02/2021&jornal=515&pagina=114.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 24 February 2021

The Draft Resolution number 965, 1 December 2020 - previously notified through G/SPS/N/BRA/1860 - was adopted as Resolution - RE number 526, 4 February 2021. The full text is available only in Portuguese and can be downloaded at:https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=08/02/2021&jornal=515&pagina=114.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 24 February 2021

The Draft Resolution number 966, 1 December 2020 - previously notified through G/SPS/N/BRA/1861 - was adopted as Resolution - RE number 527, 4 February 2021. The full text is available only in Portuguese and can be downloaded at:https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=08/02/2021&jornal=515&pagina=114.

Products Covered:

Regulation Type: Addendum to Regular Notification