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: 20 December 2021 | Final date for Comment: 08 May 2025

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: 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: 05 January 2022 | Final date for Comment: 06 March 2022

This Draft East African Standard specifies requirements, sampling and test methods for crepe bandages.

Products Covered: 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 (excl. adhesive dressings and other articles having an adhesive layer) (HS code(s): 300590); Textile fabrics (ICS code(s): 59.080.30)

Regulation Type: Regular notification

Distribution date: 05 January 2022 | Final date for Comment: 06 March 2022

The notified draft text amends Annexes 2 and 3 and Article 8 and incorporates Annex 4 into the current Regulations approved pursuant to Supreme Decree No. 001-2004-EM.

Products Covered: National subheading description: 2612.10.00.00 Uranium ores and concentrates; 2612.20.00.00 Thorium ores and concentrates; 2844.10.00.00 Natural uranium and its compounds; alloys, dispersions (including cermets), ceramic products and mixtures containing natural uranium or natural uranium compounds; 2844.20.00.00 Uranium enriched in U 235 and its compounds; plutonium and its compounds; alloys, dispersions (including cermets), ceramic products and mixtures containing uranium enriched in U 235, plutonium or compounds of these products; 2844.30.00.00 Uranium depleted in U 235 and its compounds; thorium and its compounds; alloys, dispersions (including cermets), ceramic products and mixtures containing uranium depleted in U 235, thorium or compounds of these products; 2844.40.10.00 Radioactive residues; 2844.40.90.00 Radioimmunoassay (RIA) kits and radioactive sources; 2844.50.00.00 Spent (irradiated) fuel elements (cartridges) of nuclear reactors; 2845.10.00.00 Heavy water (deuterium oxide); 8401.10.00.00 Nuclear reactors; 8401.20.00.00 Machinery and apparatus for isotopic separation, and parts thereof; 8401.30.00.00 Fuel elements (cartridges), non-irradiated; 8401.40.00.00 Parts of nuclear reactors; 8535.40.10.00 Only: Ionizing lightning arrestors (radioactive); 8543.10.00.00 Particle accelerators (cyclotron, synchrotron); 9022.12.00.00 Computed tomography apparatus; 9022.13.00.00 Other, for dental uses; 9022.14.00.00 Only: Bone densitometers, mammography devices and other medical, surgical or veterinary equipment; 9022.19.00.00 Only: Apparatus for monitoring, diffraction or analysis containing radioactive material; 9022.21.00.00 Only: Caesium-137 teletherapy units for medical use; 9022.21.00.00 Only: Apparatus for medical, surgical, dental or veterinary use; 9022.29.00.00 Only: Linear accelerators and teletherapy units, nuclear gauges (densitometers; level, weight, moisture, fill, thickness, grammage gauges, etc.), high dose rate (HDR) or low dose rate (LDR) equipment containing radioactive material; 9022.30.00.00 X-ray tubes; 9025.80.30.00 Only: Densitometers containing radioactive material; 9026.10.12.00 Only: Level gauges containing radioactive material; 9026.10.19.00 Only: Others containing radioactive material

Regulation Type: Regular notification

Distribution date: 05 January 2022 | Final date for Comment: 07 March 2022

The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to remove the prescription status for veterinary use by removing this ingredient from the Veterinary Prescription Drug List (PDL). 

Products Covered: Prescription status of medicinal ingredients for veterinary use in feed (ICS: 11.220; HS 3004.50.55)

Regulation Type: Regular notification

Distribution date: 06 January 2022 | Final date for Comment: 09 January 2022

All wastepaper and metal scrap intended to be imported into Malaysia are subject to inspection process and issuance of Certificate of Approval  as per the Customs (Prohibition of Imports) (Amendment) (No.X) Order 2021. The requirements on all incoming importation of wastepaper and metal scrap into Malaysia are specified in the Guidelines for Importation and Inspection of Waste Paper and the Guidelines for Importation and Inspection of Metal Scrap. The two guidelines have been published on SIRIM QAS website for comments from 27 February 2021 until 15 March 2021. Various engagements with local and international stakeholders have been conducted from February 2021 until November 2021. Interim measure have been enforced pending the implementation of the Guidelines for Importation and Inspection of Metal Scrap.  

Products Covered: i. Recovered (waste and scrap) paper and paperboard: HS Code 4707.10: Unbleached kraft paper or paperboard or corrugated paper or paperboard HS Code 4707.20: Other paper or paperboard made mainly of bleached chemical pulp, not coloured in the mass HS Code 4707.30: Paper or paperboard made mainly of mechanical pulp (for example, newspapers, journals and similar printed matter) ii. Waste and scrap metal: HS Code 7204: Ferrous waste and scrap; re-melting scrap ingots of iron or steel HS Code 7404: Copper waste and scrap HS Code 7602: Aluminium waste or scrap

Regulation Type: Regular notification

Distribution date: 06 January 2022 | Final date for Comment: 03 February 2022

To amend the provisions for the pyrogen test, to delete the test for leukopenic toxicity, and to introduce the endotoxin test instead of the test for toxicity to mouse weight gain in the section for “Influenza HA Vaccine”.

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 07 January 2022 | Final date for Comment: 08 May 2025

Proposal of maximum residue limits (MRLs) for the following agricultural chemical Pesticide: Broflanilide

Products Covered: - Natural honey (HS Code: 04.09) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.03, 07.04, 07.05, 07.06, 07.08, 07.09, 07.10 and 07.14) - Spices (HS Code: 09.10)

Regulation Type: Regular notification

Distribution date: 07 January 2022 | Final date for Comment: 08 March 2022

Proposal of maximum residue limits (MRLs) for the following agricultural chemical Pesticide: Cadusafos

Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.14) - Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.03, 08.05, 08.07, 08.10, 08.11 and 08.14) - Spices (HS Code: 09.10) - Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, and 12.12)

Regulation Type: Regular notification