TGA presentation: Royal Australian Chemical Institute (RACI) Pharmaceutical Chemistry Group NSW seminar, 22 November 2016

Better medicine labels: New requirements under TGOs 91 and 92

19 December 2016

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Presentation

  • Presented by: Jenny Burnett, Scientific Operations Management Section, Scientific Evaluations Branch, Therapeutic Goods Administration
  • Presented at: Royal Australian Chemical Institute (RACI) Pharmaceutical Chemistry Group NSW seminar
  • Presentation date: 22 November 2016
  • Presentation summary: This presentation discusses the recent changes to medicines labelling in Australia including the history and consultation as well as the changes and features brought in with Therapeutic Goods Order No. 91 and 92.

Transcript

Better medicine labels: New requirements under TGOs 91 and 92

Jenny Burnett
Director, Scientific Operations Management Section
Scientific Evaluation Branch
Medicines Regulation Division, TGA

Royal Australian Chemical Institute (RACI) Pharmaceutical Science Group Seminar, 22 Nov 2016

Slide 1 - Overview

  • Why update the TGO 69?
  • History and consultation
  • Labelling Orders - changes and features
  • Latest developments…

Slide 2 - Updating the labelling Order

Responding to internal and external stakeholder needs:

  • Medicine labels and QUM
  • Addressing technical inadequacies
  • Clearer labelling requirements
  • Need for international alignment

Slide 3 - Reform outcomes

Consistent location of important health information

Ensure important information is not obscured

Improve safety and quality use of medicines for consumers

Reduce medication errors

Slide 4 - History and consultation

Timeline displaying the history and consultation of changes top medicine labels. Pre-2014 to early 2014: Various review of labelling and packaging. Early 2014 to late 2014: Redraft of TGO79. Late 2014: 2014 public consultation. Late 2014 to late 2015: - Draft TGO 91: Prescription medicines - Draft TGO 92: Non-prescription medicines. Late 2015: 2015 targeted consultation. Start 2016 to August 2016: Draft TGOs 91 & 92 finalisation.

2001 - Re-drafting of TGO 69 commenced

2012 - Public consultation on labelling and packaging

2013 - Review of Evidence regarding key issues about labelling and packaging

Post ANZTPA - removal of 'packaging' requirements from scope of review

Post 2014 public consultation, TGO 79 was split into two separate orders: TGO 91 and 92.

Stakeholders who provided submissions in 2014 public consultation were invited to comment.

Slide 5 - Two labelling Orders

Road sign showing a road splitting into two. TGO 69 becomes TGO 91 and TGO 92.

TGO 91 - For prescription and related medicines

TGO 92 - For non-prescription medicines

Slide 6 - Key features and changes to labelling requirements

Slide 7 - Implementation of the new requirements

TGO 91 and 92 are registered on the Federal Register of Legislation (FRL)

  • Commencement date → 31 August 2016
  • Transition period → ends 31 August 2020

TGO 69 has no effect from 1 September 2020

Slide 8 - 4 year transition period

The flow chart describing the 4 year transition period is written below as a series of numbered steps. 1) a) Prescription b) TGO 69 or TGO 91 c) End of transition Period d) TGO 91 2) a) Non-prescription b) TGO 69 or TGO 92 c) End of transition period d) TGO 92

Slide 9 - Prominence of active ingredient

  • Larger and clearer text
  • Consistent location of information
  • Easier identification of active ingredient name and quantity information

Slide 10 - Schedule 1 - Declarable substances

  • Informing consumers!
  • The list has grown
    • Crustacea
    • Fish
    • Eggs
    • Soya
    • Milk
    • Tree nuts
  • Prescription Medicines can use a label statement referring consumers to the CMI for declarable substances

Slide 11 - Declarable substances - testing implications

  • 'Substances' NOT excipients
  • Testing rationales
  • Some entries have been modified
    • Gluten now has a 20ppm cut off

Slide 12 - Key prescription medicine changes

  • Medicine name to be on at least 3 sides of the carton
  • Mandatory 70x30mm space for dispensing labels
  • Small containers now 25mL capacity
  • Microgram and microlitre must be spelled out in full (no µ allowed except small and very small containers)

Slide 13 - Prescription medicine label

An example of a prescription medicine label. Front of packaging: - A label points to the top right corner: Statement identify substance from Schedule 1. - A label points to the Active ingredients: Active ingredients immediately below medicine name AND larger text size. Back of packaging: - A label points to a large area taking up approx 3/4 of the space: Dedicated space for pharmacy label.

Slide 14 - Key non-prescription medicine changes

Example of the Medicine information on a non-prescription medicine label.

  • Display of Critical Health Information (CHI) for AUST R medicines
  • Use of 'active moiety' on main label instead of full ingredient name
  • Changes to container sizes
    • Small containers now 25mL capacity
    • New medium container size up to 60mL

Slide 15 - Non-prescription OTC medicine label

Example Non-prescription OTC medicine label. Front of packaging: - Active ingredients immediately below medicine name AND larger text size. - No additional information between medicine name and active ingredient. - Improved contrast between required information and background. Back of packaging: - Critical Health information in tabulated format with headings in specified order (On this image: Active ingredients, Uses, Warnings (voluntary subheading Allergens), Directions for use, Other informtion.)

Slide 16 - Non-prescription listed medicine label

Example Non-prescription listed medicine label. Front of packaging: - No logos or pictures that break up the medicine name - Active ingredients immediately below medicine name (no new text size requirements).Back of packaging: - Improved contrast between required information and background.

Slide 17 - Country of origin

  • No requirement under therapeutic goods legislation
  • Commerce (Imports) Regulations 1940
  • Australian Consumer Law
    • 'substantial transformation'

Slide 18 - Now that it is out in the world…

Further amendments

  • Multiple 'declarable substance' statements
  • Clarity and consistency in Na and K statements
  • New name for re-made TGO 69
  • More guidance

Slide 19 - Questions?

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