Distribution date: 09 November 2020 | Final date for Comment: 08 January 2021

The Therapeutic Goods Administration (TGA) is proposing a new standard to outline requirements for medicine serialisation and the application of data matrix codes to the labels of certain medicines supplied in Australia. The introduction of the standard is not intended to mandate the use of data matrix codes or serialisation. Instead, it sets out the technical requirements where the medicine sponsor chooses to implement either of these.  The purpose of the standard is to give clarity and certainty for adopters of data matrix codes and serialisation of medicines supplied in Australia. It is the first step in establishing requirements that support all systems relying on the codes. The requirements align, where possible, with global standards to provide consistency for sponsors and manufacturers operating in multiple jurisdictions and to ensure global interoperability.  Australia does not currently have the infrastructure to facilitate medicine tracking. The introduction of the new standard will occur independently from the broader considerations needed before Australia determines which track and trace system is appropriate for our medicine supply chain.  A public consultation on the draft standard was open from July to August 2020. Respondents provided a range of suggestions to improve the new standard and associated guidance, with many supporting the implementation of a standard to provide consistent regulatory requirements which align with international standards. The draft standard and consultation documents are available at https://consultations.health.gov.au/medicines-regulation-division/consultation-tgo106-data-matrix-codes-on-medicines/. The TGA is reviewing all the submissions received and will make changes to the draft standard and guidance in consideration of this feedback. It is planned that the updated standard will be implemented in January 2021, with a delayed commencement period (up to 2 years) to allow sufficient time for sponsors currently applying data matrix codes and/or serialising to comply with the standard.

Products Covered: Medicines

Regulation Type: Regular notification

Distribution date: 09 November 2020 | Final date for Comment: 08 January 2021

The Therapeutic Goods Administration (TGA) is proposing a new standard to outline requirements for medicine serialisation and the application of data matrix codes to the labels of certain medicines supplied in Australia. The introduction of the standard is not intended to mandate the use of data matrix codes or serialisation. Instead, it sets out the technical requirements where the medicine sponsor chooses to implement either of these.  The purpose of the standard is to give clarity and certainty for adopters of data matrix codes and serialisation of medicines supplied in Australia. It is the first step in establishing requirements that support all systems relying on the codes. The requirements align, where possible, with global standards to provide consistency for sponsors and manufacturers operating in multiple jurisdictions and to ensure global interoperability.  Australia does not currently have the infrastructure to facilitate medicine tracking. The introduction of the new standard will occur independently from the broader considerations needed before Australia determines which track and trace system is appropriate for our medicine supply chain.  A public consultation on the draft standard was open from July to August 2020. Respondents provided a range of suggestions to improve the new standard and associated guidance, with many supporting the implementation of a standard to provide consistent regulatory requirements which align with international standards. The draft standard and consultation documents are available at https://consultations.health.gov.au/medicines-regulation-division/consultation-tgo106-data-matrix-codes-on-medicines/. The TGA is reviewing all the submissions received and will make changes to the draft standard and guidance in consideration of this feedback. It is planned that the updated standard will be implemented in January 2021, with a delayed commencement period (up to 2 years) to allow sufficient time for sponsors currently applying data matrix codes and/or serialising to comply with the standard.

Products Covered: Medicines

Regulation Type: Regular notification

Distribution date: 06 November 2020 | Final date for Comment: 05 January 2021

This Standard specifies the classification, packaging form, packaging structure, specifications, requirements, test methods, inspection rules, identification, transportation and storage of solid cyanide (potassium cyanide, sodium cyanide) (hereinafter referred to as cyanide). This standard is applicable to solid cyanide packaging.

Products Covered: - Cyanides and cyanide oxides : (HS code(s): 28371); Protection against dangerous goods (ICS code(s): 13.300)

Regulation Type: Regular notification

Distribution date: 06 November 2020 | Final date for Comment: 05 January 2021

This Standard specifies the classification, packaging form, packaging structure, specifications, requirements, test methods, inspection rules, identification, transportation and storage of solid cyanide (potassium cyanide, sodium cyanide) (hereinafter referred to as cyanide). This standard is applicable to solid cyanide packaging.

Products Covered: - Cyanides and cyanide oxides : (HS code(s): 28371); Protection against dangerous goods (ICS code(s): 13.300)

Regulation Type: Regular notification

Distribution date: 06 November 2020 | Final date for Comment: 05 January 2021

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

Products Covered: -Meat and edible meat offal (HS: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.08 and 02.09) -Dairy produce (HS: 04.01) -Animal originated products (HS: 05.04) -Edible vegetables and certain roots and tubers (HS: 07.02, 07.03, 07.04, 07.05, 07.07, 07.09, 07.10 and 07.13) -Edible fruit, nuts and peel of citrus fruit (HS: 08.01, 08.02, 08.04, 08.05, 08.06, 08.08, 08.09, 08.10, 08.11 and 08.14) -Mate and spices (HS: 09.03, 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: 12.07 12.10 and 12.12)-Animal fats and oils (HS: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Distribution date: 06 November 2020 | Final date for Comment: 05 January 2021

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

Products Covered: -Meat and edible meat offal (HS: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.08 and 02.09) -Dairy produce (HS: 04.01) -Animal originated products (HS: 05.04) -Edible vegetables and certain roots and tubers (HS: 07.02, 07.03, 07.04, 07.05, 07.07, 07.09, 07.10 and 07.13) -Edible fruit, nuts and peel of citrus fruit (HS: 08.01, 08.02, 08.04, 08.05, 08.06, 08.08, 08.09, 08.10, 08.11 and 08.14) -Mate and spices (HS: 09.03, 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: 12.07 12.10 and 12.12)-Animal fats and oils (HS: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Distribution date: 06 November 2020

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

Products Covered: -Edible vegetables and certain roots and tubers (HS: 07.02, 07.03, 07.04, 07.06, 07.09 and 07.10) -Edible fruit and peel of citrus fruit (HS: 08.04, 08.05, 08.07, 08.10, 08.11 and 08.14) -Tea and spices (HS: 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: 12.07)

Regulation Type: Regular notification

Distribution date: 06 November 2020

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

Products Covered: -Edible vegetables and certain roots and tubers (HS: 07.02, 07.03, 07.04, 07.06, 07.09 and 07.10) -Edible fruit and peel of citrus fruit (HS: 08.04, 08.05, 08.07, 08.10, 08.11 and 08.14) -Tea and spices (HS: 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: 12.07)

Regulation Type: Regular notification

Distribution date: 06 November 2020 | Final date for Comment: 05 January 2021

Proposed maximum residue limits (MRLs) for the following agricultural chemical Pesticide: Cartap, Thiocyclam and Bensultap

Products Covered: -Edible vegetables and certain roots and tubers (HS: 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, nuts, and peel of citrus fruit (HS: 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) -Tea, mate and spices (HS: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) -Cereals (HS: 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: 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12)   

Regulation Type: Regular notification

Distribution date: 06 November 2020 | Final date for Comment: 05 January 2021

Proposed maximum residue limits (MRLs) for the following agricultural chemical Pesticide: Cartap, Thiocyclam and Bensultap

Products Covered: -Edible vegetables and certain roots and tubers (HS: 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, nuts, and peel of citrus fruit (HS: 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) -Tea, mate and spices (HS: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) -Cereals (HS: 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: 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12)   

Regulation Type: Regular notification