National Standard of the P.R.C., Solid Cyanide Package
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
Proposed new standard for medicine serialisation and data matrix codes - Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2020
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
Proposed new standard for medicine serialisation and data matrix codes - Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2020
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
Revision of the Standards and Specifications for Foods and Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 10 November 2020 | Final date for Comment: 17 May 2025
The proposed maximum residue limits (MRLs) for Carbofuran notified in G/SPS/N/JPN/742 (dated 1 April 2020) were adopted and published on 14 July 2020. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Revision of the Standards and Specifications for Foods and Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 10 November 2020 | Final date for Comment: 17 May 2025
The proposed maximum residue limits (MRLs) for Carbofuran notified in G/SPS/N/JPN/742 (dated 1 April 2020) were adopted and published on 14 July 2020. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Revision of the Standards and Specifications for Foods and Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 10 November 2020 | Final date for Comment: 17 May 2025
The proposed maximum residue limits (MRLs) for Aldrin and Dieldrin notified in G/SPS/N/JPN/740 (dated 1 April 2020) were adopted and published on 14 July 2020. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Revision of the Standards and Specifications for Foods and Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 10 November 2020 | Final date for Comment: 17 May 2025
The proposed maximum residue limits (MRLs) for Aldrin and Dieldrin notified in G/SPS/N/JPN/740 (dated 1 April 2020) were adopted and published on 14 July 2020. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Revision of the Standards and Specifications for Foods and Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)
Distribution date: 10 November 2020 | Final date for Comment: 17 May 2025
The proposed maximum residue limits (MRLs) for Benfuracarb notified in G/SPS/N/JPN/741 (dated 1 April 2020) were adopted and published on 14 July 2020. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Revision of the Standards and Specifications for Foods and Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)
Distribution date: 10 November 2020 | Final date for Comment: 17 May 2025
The proposed maximum residue limits (MRLs) for Benfuracarb notified in G/SPS/N/JPN/741 (dated 1 April 2020) were adopted and published on 14 July 2020. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
Revision of the Standards and Specifications for Foods and Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule).
Distribution date: 10 November 2020 | Final date for Comment: 17 May 2025
The proposed maximum residue limits (MRLs) for Carbaryl notified in G/SPS/N/JPN/748 (dated 1 April 2020) were adopted and published on 14 July 2020. The specified MRLs are available as below:
Products Covered:
Regulation Type: Addendum to Regular Notification
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