Regulatory Updates

Distribution date: 06 April 2021 | Final date for Comment: 05 June 2021

The Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices, and the Public Notice on Designated Biological Products under Article 197, Paragraph 2 of the Regulation for Enforcement will be partially amended to reflect the World Health Organization (WHO) standard on Summary Lot Protocol (SLP).

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

Regulation Type: Regular notification

Distribution date: 01 April 2021

In March 2021, a new standard, Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021 was registered on the Federal Register of Legislation. The standard commences on 1 January 2023. TGO 106 does not mandate medicine serialisation or the application of data matrix codes to medicines, but sets out the technical requirements if the medicine sponsor implements either of these. Medicines released for supply from 1 January 2023 must comply with the requirements of TGO 106 if they: are serialised include a data matrix code which encodes the Global Trade Item Number (GTIN). TGO 106 defines the requirements for the presentation and content of data matrix codes including human readability requirements and relationship with other machine readable codes. The requirements include: Where a medicine is serialised this must be represented by a serial number encoded into a data matrix code that complies with the GS1 General Specifications for a DataMatrix. If a data matrix code containing a GTIN is applied to a unit of a medicine, this must be formatted as a GS1 DataMatrix that complies with the GS1 General Specifications. TGO 106 does not set out any requirements regarding reporting, storage and verification of serialisation data.

Products Covered: Medicines

Regulation Type: Addendum to Regular Notification

Distribution date: 01 April 2021 | Final date for Comment: 31 May 2021

Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: Prochloraz

Products Covered: -Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) -Dairy produce and birds' eggs (HS Codes: 04.01, 04.07 and 04.08) -Animal originated products (HS Code: 05.04) -Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) -Edible fruit, nuts and peel of citrus fruit (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) -Coffee, tea, mate and spices (HS Codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) -Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) -Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12)-Animal or vegetable fats and oils (HS Codes: 15.01, 15.02, 15.06 and 15.12)

Regulation Type: Regular notification

Distribution date: 01 April 2021

Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: Kasugamycin

Products Covered: -Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.13) -Edible fruit, nuts and peel of citrus fruit (HS Codes: 08.02, 08.04, 08.05, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) -Tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) -Cereals (HS Code: 10.06)-Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.07 and 12.12)

Regulation Type: Regular notification

Distribution date: 01 April 2021 | Final date for Comment: 31 May 2021

Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: Fenpropathrin

Products Covered: -Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) -Dairy produce and birds' eggs (HS Codes: 04.01, 04.07 and 04.08) -Animal originated products (HS Code: 05.04) -Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.04, 07.07, 07.09, 07.10 and 07.13) -Edible fruit, nuts and peel of citrus fruit (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) -Coffee, tea and spices (HS Codes: 09.01, 09.02, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) -Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.02, 12.07 and 12.10)-Animal fats and oils (HS Codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Distribution date: 01 April 2021

Proposed maximum residue limits (MRLs) for the following agricultural chemical - Feed additive: Dibutylhydroxytoluene.

Products Covered: -Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) -Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03, 03.04 and 03.06)-Dairy produce and birds' eggs (HS Codes: 04.01, 04.07 and 04.08) -Animal originated products (HS Code: 05.04)-Animal fats and oils (HS Codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Distribution date: 01 April 2021

Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: 1-Methylcyclopropene

Products Covered: -Edible vegetables and certain roots and tubers (HS Codes: 07.01 and 07.10)-Edible fruit and nuts (HS Codes: 08.03, 08.08, 08.09, 08.10 and 08.11)

Regulation Type: Regular notification

Distribution date: 01 April 2021

Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: Chloropicrin

Products Covered: -Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14)-Edible fruit and peel of citrus fruit (HS Codes: 08.07, 08.08, 08.10, 08.11 and 08.14) -Mate and spices (HS Codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) -Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08)-Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.02, 12.07 and 12.12)

Regulation Type: Regular notification

Distribution date: 01 April 2021 | Final date for Comment: 31 May 2021

Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: Validamycin

Products Covered: -Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.14) -Edible fruit and peel of citrus fruit (HS Codes: 08.05, 08.09, 08.10, 08.11 and 08.14) -Mate and spices (HS Codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) -Cereals (HS Codes: 10.05 and 10.06)-Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.07 and 12.12)

Regulation Type: Regular notification

Distribution date: 01 April 2021

Proposed maximum residue limits (MRLs) for the following agricultural chemical - Veterinary drug: Trenbolone Acetate.

Products Covered: -Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) -Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08) -Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07, 04.08 and 04.09) -Animal originated products (HS Code: 05.04)-Animal fats and oils (HS Codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification