Regulatory Updates

Distribution date: 22 December 2021 | Final date for Comment: 20 February 2022

The Therapeutic Goods Administration (TGA) is seeking comment on a package of reforms in relation to the manufacturing, labelling and packaging requirements for Medicinal Cannabis Products made available in Australia or supplied to Australians. Background In recent years, Australian Governments at Commonwealth, State and Territory levels have implemented legislative and policy changes to allow the cultivation, manufacture and supply of medicinal cannabis for patients in Australia. The TGA administers Australia’s national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods in Australia. Typically, therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG). If they are not included in the ARTG, these goods can only be lawfully supplied in, imported into, or exported from Australia if they are subject to an exemption, approval or authority. Therapeutic goods not on the ARTG are referred to as ‘unapproved products’. Currently, most medicinal cannabis products are unapproved products. Unapproved medicinal cannabis products can be accessed via the Authorised Prescriber Scheme (AP), Special Access Scheme (SAS) or clinical trials. The TGA requires certain standards for medicinal cannabis products accessed in Australia, as set out principally in TGO 93. At present, Australian manufacturers must comply with Good Manufacturing Practice (GMP) standards, whereas a similar requirement does not apply to product imported into Australia. Reform proposal There has been a significant increase in the supply and use of medicinal cannabis products in Australia. In light of this, the TGA recently undertook a review of the regulation of medicinal cannabis products manufacturing, labelling and packaging, which included a public consultation held between December 2020 and January 2021. The TGA has subsequently developed a package of reforms, described below. TGO 93 and the Regulations are proposed to be amended to require the following: Imported medicinal cannabis products will be required to be manufactured on sites with acceptable GMP standards. Sponsors (the companies importing the goods) must maintain evidence to show compliance for each batch of medicinal cannabis products. The TGA will provide sponsors with clear guidance on the GMP practices and evidence required, which will be in accordance with existing recognised global standards and/or accreditation. This measure provides greater certainty on the quality and safety of products available to Australian patients. It extends broadly the same standards to offshore manufacturers currently required of Australian manufacturers. For the avoidance of doubt, the TGA will not be requiring sponsors of offshore manufacturers to comply with a unique Australian manufacturing standard. Sponsors will be able to rely on a manufacturer’s adherence to an internationally accepted GMP standard (of a type acceptable to the TGA) that may be specific to that manufacturer’s country. Extemporaneous compounding by medical practitioners and pharmacists will require approval from the TGA under the Special Access Scheme (SAS). Medicinal cannabis manufactured outside of Australia can still be used in extemporaneous compounding. TGO 93 will be amended to include requirements for (a) a child resistant closure on high risk goods, which is normal practice for medicines that present a poisoning risk (b) labelling that better identifies the active ingredients and (c) clarity on microbiological testing requirements. Clear guidance on the requirements – and a reasonable transition period – will be provided.

Products Covered: Medicinal cannabis products (being therapeutic goods that contain, or are manufactured from, any part of the cannabis plant) and any ingredients used in the manufacture of those products (including, but not limited to, the cannabis plant). For the purposes of this notification, ‘cannabis plant’ means any plant, or part of a plant, of the genus Cannabis, including, but not limited to, the flowers, fruiting tops, seeds, stems and leaves of the plant.

Regulation Type: Regular notification

Distribution date: 20 December 2021

The following Veterinary Conditions have been reviewed to align with the OIE's Terrestrial Animal Health Code (TAHC) Chapter 10.4 Infection with High Pathogenicity Avian Influenza Viruses that was adopted at the OIE 88th General Session in May 2021: 1. Veterinary Conditions for Importation of Pet Animals – Birds (other than domestic birds);2. Veterinary Conditions for Importation of Hatching Eggs (for lab use);3. Veterinary Conditions for importation of Veterinary Biologics – Viruses of Animals and Birds: Type Cultures/Strains;4. Veterinary Conditions for importation of Veterinary Biologics – Viruses of Animals and Birds: Laboratory Isolates. A summary of the revisions is is here:https://members.wto.org/crnattachments/2021/SPS/SGP/21_7603_01_e.pdf

Products Covered: Birds (other than domestic birds) (HS Codes: 01063200, 01063900), hatching eggs (HS Code: 30063020), and viruses of animals and birds: type culture/strains and laboratory isolate (HS Code: 30029000)

Regulation Type: Regular notification

Distribution date: 20 December 2021 | Final date for Comment: 18 February 2022

This document specifies the terms, definitions, technical requirements, test methods, labelling and information of chemical and microbial protective gloves.  This document applies to gloves for protection against chemical and microbial hazards.

Products Covered: Chemical and microbial protective gloves

Regulation Type: Regular notification

Distribution date: 17 December 2021 | Final date for Comment: 15 February 2022

This document specifies the terms and definitions, technical requirements, test methods, inspection rules, labeling, packaging, transportation, storage and shelf life of feed additive cellulase.This document applies to the feed additive cellulase prepared by fermentation, separation and purification with or without carrier, using Trichoderma longibrachiatum, Aspergillus niger, Penicillium funiculosum and Pythium solitarium as strains.

Products Covered: Feed additive cellulase

Regulation Type: Regular notification

Distribution date: 17 December 2021 | Final date for Comment: 15 February 2022

The “Regulation on Quasi-drug Approval, Notification and Review” is being amended by the Ministry of Food and Drug Safety (MFDS) as follows: A. For external disinfectants containing benzalconium chloride, spraying is being excluded from the instructions for use. B. External disinfectants that use direct containers in the form of packets or stopper-mounted pouches are required to be indicated in packaging units that exceed 200 mL. C. Products used for hygienic treatment of postpartum haemorrhage or lochia (postpartum vaginal discharge) have been additionally designated as quasi-drugs (enforcement date: Oct 1, 2021); accordingly, the scope of safety and effectiveness review data that need to be submitted for these products is to be defined.

Products Covered: Quasi-drugs (HS code 3808.94-0000), Quasi-drugs (HS code 9619.99-1090)

Regulation Type: Regular notification

Distribution date: 16 December 2021

The notified text amends chapter 11 of Mexican Official Standard NOM-244-SSA1-2020 on assessing the bacteria-reducing efficiency of equipment and germicides for domestic water treatment. Sanitary requirements, to be read as follows: 11. Entry into force: This Mexican Official Standard shall enter into force 180 calendar days after its publication in the Official Journal, except for paragraph 6.5 and its subparagraphs and paragraph A.10.6 of Regulatory Appendix A of this Standard, which shall enter into force on 13 September 2022. __________

Products Covered: Equipment and/or germicides for domestic water treatment; national subheadings concerned: 842121 and 380894

Regulation Type: Addendum to Regular Notification

Distribution date: 15 December 2021 | Final date for Comment: 13 February 2022

This Draft East African Standard specifies requirements, sampling and test methods for creams, lotions and gels for skincare. This standard does not apply to skincare products, for which therapeutic claims are made. This standard does not apply to anti-aging, anti-wrinkle, sun protection products, aromatherapy substances and Alpha Hydroxy Acids (AHA).

Products Covered: Skincare creams, lotions, gels

Regulation Type: Regular notification

Distribution date: 15 December 2021

The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; DUS DEAS 961:2019, Glycerine for cosmetic industry — Specification, First Edition; notified in G/TBT/N/UGA/1065 and G/TBT/N/UGA/1065/Add.1 entered into force on 10 September 2021. The Uganda Standard, US EAS 961:2020,Glycerine for cosmetic industry — Specification, First Edition, can be purchased online through the link: https://webstore.unbs.go.ug/

Products Covered: Glycerine for cosmetic industry

Regulation Type: Addendum to Regular Notification

Distribution date: 15 December 2021 | Final date for Comment: 13 February 2022

This Draft East African Standard specifies the requirements, sampling and test methods for baby powders. This standard does not apply to medicated powders for which medicinal claims are made.

Products Covered: Baby powder

Regulation Type: Regular notification

Distribution date: 15 December 2021

The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; DUS DEAS 965:2019, Lipstick — Specification, First Edition; notified in G/TBT/N/UGA/1069 and G/TBT/N/UGA/1069/Add.1 entered into force on 10 September 2021. The Uganda Standard, US EAS 965:2020, Lipstick — Specification, First Edition, can be purchased online through the link: https://webstore.unbs.go.ug/

Products Covered: Lipstick

Regulation Type: Addendum to Regular Notification