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Labelling & packaging

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

Labelling

• TGA labelling and packaging regulatory framework
  Information on the TGA labelling and packaging regulatory framework
• Labelling and packaging review
  The TGA is initiating a review of the labelling and packaging regulatory framework
• 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)
• A guide to labelling drugs and poisons
  Guide to assist manufacturers and packers of poisons to draft labels which comply with the harmonised requirements as they exist on 1 July 2000
• Best practice guideline on prescription medicine labelling
  Guideline to guide pharmaceutical sponsors and TGA assessors in the design and review of the acceptability of prescription medicine labelling
• NDPSC guide to the packaging, labelling and regulation of paints, tinters and related products
  This guide applies only to paints, tinters and related products that contain poisons. These requirements are constantly under review and future modifications are to be anticipated

Packaging

• TGA labelling and packaging regulatory framework
  Information on the TGA labelling and packaging regulatory framework
• Tamper-evident packaging code of practice
  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
• NDPSC guide to the packaging, labelling and regulation of paints, tinters and related products
  This guide applies only to paints, tinters and related products that contain poisons. These requirements are constantly under review and future modifications are to be anticipated

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

• Labelling/packaging exemptions
  Notices of labelling/packaging exemptions
• Required advisory statements for medicine labels (RASML) gazette notices
  Gazettes notices about changes to the Required Advisory Statements for Medicine Labels (RASML)