Labelling and packaging

Labelling and packaging is part of the Australian system of regulating medicines and medical devices.

Labelling

• Labels for COVID-19 vaccines
• Labels for COVID-19 treatments
• Australia's medicine labels are becoming clearer
  Requirements to make Australian medicine labels clearer and more consistent were introduced from 31 August 2016
  • Labelling changes: information for sponsors
• TGO 91 - Standard for labels of prescription and related medicines (TGO91)
• TGO 92 - Standard for labels of non-prescription medicines (TGO92)
  • Medicine labels: Guidance on TGO 91 and TGO 92
• Required Advisory Statements for Medicine Labels (RASML)
  Advisory statements apply to all medicines for supply in Australia (i.e. registered prescription, non-prescription and complementary medicines, listed and exempt medicines)
  • Guidance on using the Required Advisory Statements for Medicine Labels (RASML)
    Information on how to find out which statements (if any) are required by the RASML for a particular over-the-counter or complementary medicine
  • Required advisory statements for medicine labels (RASML): proposals to amend the RASML
    Information on the process for updating advisory statements in the RASML
• Serialisation and data matrix codes on medicines
  Standard clarifying Australian requirements for data matrix codes and medicine serialisation commencing on 1 January 2023
  • Therapeutic Goods (Medicines - Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021
  • Standard for serialisation and data matrix codes on medicines: Guidance for TGO 106
  • Medicine packaging definitions for sponsors

Packaging

• Code of practice for tamper-evident packaging of therapeutic goods
  Tamper-evident packaging of therapeutic goods that may be vulnerable to tampering (either deliberate or accidental) is important in ensuring consumer safety and the integrity of the goods
• Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017
  Requirements for child resistant packaging of identified substances
  • Guidance on TGO 95
    A plain English explanation of TGO 95 requirements

Labelling & packaging forms

• Proposal to amend the Required Advisory Statements for Medicine Labels (RASML)
  Use this form to propose an amendment to the Required Advisory Statements for Medicine Labels (RASML)

Regulatory decisions & notices

• Therapeutic Goods (Poisons Standard) (Benzylpenicillin - Seqirus) Exemption 2022
  21 July 2022: The TGA has issued a labelling exemption for Benzylpenicillin - Seqirus under section 1.1(3) of Part 2 of the current Poisons Standard.
• New standard for serialisation and data matrix codes on medicines of medicines
  26 March 2021: TGO 106 is a new standard clarifying Australian requirements for serialisation and data matrix codes on medicines coming into effect on 1 January 2023.
• Changes to ingredient names: End of transition period - are you ready?
  24 June 2019: The transition period for updating medicine ingredient names ends on 30 April 2020.
• Changes to adrenaline and noradrenaline labels
  24 June 2019: Medicines containing adrenaline and noradrenaline will start to include the international names epinephrine and norepinephrine on labels and information leaflets
• Updating medicine ingredient names - information for sponsors
  24 June 2019: Information for sponsors on the transition period for the harmonisation of medicine ingredient names. All medicines will need to use the updated ingredient names from 1 May 2020.
• Medicines Advisory Statements Specification updates
  1 March 2019: Notice of publication of Therapeutic Goods (Medicines Advisory Statements) Specification 2019
• Updating medicine ingredient names - list of affected ingredients
  28 November 2018: View the searchable list of changing medicine ingredient names
• Updating medicine ingredient names
  2 November 2018: We are updating some medicine ingredient names used in Australia to align with names used internationally
• New warnings on labels of medicines containing neuromuscular blocking agents
  29 June 2018: New requirements for neuromuscular blocking agent containing medicines come into effect on 2 July

Regulation impact statements

• Regulation impact statement: General requirements for labels for medicines
  July 2016: The purpose of this RIS is to assist the Australian Government decision making process on how to address problems that have been identified in relation to the labelling of medicines in Australia
• Regulation impact statement: International harmonisation of ingredient names
  November 2015: This RIS documents the decision to update the Australian approved names of ingredients used in medicines to better align with international standards