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TGA presentation: Codeine Industry Forum, 11 May 2017

Regulatory options for up-scheduling

19 May 2017


These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.


  • Presented by: Felicity Jameson, John Churchill, Mayada Kayali
  • Presented at: Codeine Industry Forum, Sydney
  • Presentation date: 11 May 2017
  • Presentation summary: To provide sponsors of OTC codeine products with information on how to submit an application to change the class of their product from OTC to prescription medicine.


Regulatory options for up-scheduling

Felicity Jameson, Prescription Medicines Authorisation Branch
John Churchill, Scientific Evaluation Branch
Mayada Kayali, Complementary and Over the Counter Medicines Branch

Codeine Industry Forum, 11 May 2017

Slide 1 - Codeine Industry Forum Agenda

  1. Introduction to the Forum
  2. Introduction to Prescription Medicines Authorisation Branch (PMAB) and Scientific Evaluation Branch (SEB)
  3. TGA application processes & data requirements
    (a) Converting existing S2/S3 medicines to S4:
    • Process for varying existing medicines
    • Data requirements for existing medicines (converted to S4)
    (b) New applications for codeine containing medicines submitted prior to 1 Feb 2018 and those submitted on or after 1 Feb 2018
    • Process and data requirements
  4. Supply of remaining S2 & S3 stock after 31 January 2018
  • Labelling
  • Advertising
  • RASML update (Effective 1 July 2017)
  • Management of ARTG entries
    • ARTG scheduling status on 1 February 2018
    • Annual fees
    • Cancelled Products

    Slide 2 - Prescription Medicines Authorisation Branch Introduction

    Regulatory options for up-scheduling

    Thursday 11 May 2017
    Dr Felicity Jameson
    Prescription Medicines Authorisation Branch

    Slide 3 - Prescription Medicines Registration

    Flow chart of prescription medicines registration process

    Medicines Regulation Division Medical Devices Product Quality Division
    Pharmacovigilance and Special Access Branch Laboratories Branch
    Scientific Evaluation Branch Manufacturing Quality Branch
    Prescription Medicines Authorisation Branch  
    PM Registration Processes

    Pharmaceutical Benefits Division

    Slide 4 - Prescription Medicines Authorisation Branch Structure

    • The Prescription Medicines Authorisation Branch is comprised of 5 Clinical Evaluation Units (CEU).
    • Each unit is responsible for assessing prescription medicines applications within particular therapeutic areas.
    • Analgesia
    • Neurological disorders
    • Psychiatric/Psychological/Behavioural disorders
    • Anaesthesia
    • Gastrointestinal disorders
    • Nutrition
    • Disorders of the mouth
    • Disorders of the skin
    • Disorders of the ear
    • Infectious diseases
    • Vaccination against infectious disease
    • Immunological disorders
    • Other
      • radiological agents (e.g. contrast media)
      • adjuncts to radiopharmaceuticals and contrast media use
      • diagnostic tests for infections
      • allergens (diagnostic or therapeutic)
      • antivenenes
      • radiopharmaceuticals for cancer (diagnostic)
    • Cardiac disorders
    • Lipid disorders
    • Inherited metabolic disorders
    • Vascular disorders
    • Disorders of the male reproductive system
    • Poisoning
    • Neoplastic disorders
    • Haematological disorders
    • Other
      • radiopharmaceuticals for cancer (therapeutic)
    • Contraception
    • Infertility
    • Obesity
    • Endocrine disorders
    • Disorders of the female reproductive system
    • Pregnancy and labour
    • Fluid & electrolyte disorders
    • Disorders of the eye
    • Respiratory disorders
    • Disorders of the nose, paranasal sinuses & upper airway
    • Renal & urinary tract disorders
    • Bone disorders

    Further information can be found in Guidance 4 of the Australian Guidelines for Prescription Medicines (ARGPM)

    Slide 5 - Branch Overview: Sections

    Application Management and Exports Business Review and Reporting Policy and Reform Facilitation Evaluation Management Transparency and Advisory Management

    Application Entry Team

    Application Support Team


    FOI requests

    Retrospective performance reporting

    Key Performance Indicate reporting for prescription medicines

    Half Yearly Performance Reports

    Weekly workload management reporting for Section Heads

    Sponsor Pipeline Reporting (Forecasting)

    Business improvements and solutions

    Implementation of the recommendations of the MMDR

    Associated legislative and guidance change

    Change management

    Case Management

    External evaluator procurement

    Evaluation Support Unit


    Pre-submission meetings

    AusPAR preparation and publication

    Secretary of Advisory Committee for Medicines

    Media and ministerial enquiries

    Slide 6 - Minor Variations for Prescription Medicines - Chemical entities

    Converting from Schedule 2 or 3 to Schedule 4

    • New Registrations:
      • Application form to register or vary the registration of prescription medicines (Category 1 application)
      • Section 23 Category 3 application that creates a separate and distinct good
      • Section 23 Self-assessable request (SAR) that creates a separate and distinct good
      • Additional trade name
    • Variations:
      • Application form to register or vary the registration of prescription medicines (Category 1 application)
      • 9D(1) Request to correct an ARTG entry
      • 9D(2) Safety-related request (SRR) to vary an ARTG entry
      • 9D(3) Category 3 application to vary an ARTG entry
      • 9D(3) Self-assessable request (SAR) to vary an ARTG entry or minor editorial change to the PI

    Further information on minor variations applications for prescription medicines can be found on the TGA website.

    Slide 7 - 9D(3) Minor variation request

    M1 – Changes to medicines and poisons scheduling

    Specific conditions

    • The change in scheduling is from a Schedule 2 or 3 medicine to a Schedule 4 or 8, or from a Schedule 4 to a Schedule 8 medicine, or
    • The medicine has been rescheduled from Schedule 4 or 8 to Schedule 2 or 3, but continues to be regulated as a prescription medicine (see Part 1 of Schedule 10 of the Regulations).

    Required information

    • Relevant evidence of the change, such as a copy of the final Advisory Committee on Medicines Scheduling decision
    • A copy of the revised labels
    • A clean and marked-up copy of the proposed Product Information document.

    45 working day timeframe

    Labels: Pharmaceutical Chemistry Section within SEB

    Product Information: Clinical Evaluation Unit 1 within PMAB

    Approval letter will reflect timing of conversion from S3 to S4.

    Slide 8 - Available regulatory options

    Flowchart showing available regulatory options

    Slide 9 - New Applications for Codeine Containing Medicines

    Regulatory options for up-scheduling

    Dr John Churchill
    Scientific Evaluation Branch
    Medicines Authorisation Division

    Slide 10 - Over-the-counter medicines

    Australian regulatory guidelines for OTC medicines (ARGOM)

    • N1 Generic medicines (clones or flavour etc variants)
    • N2 Generic medicines that fully meet a specific OTC monograph
    • N3 Generic medicines that are not an N1, N2 or N4 level application (N3 applications require CTD Modules 1 and 3)
    • N4 Generic medicines that are one or more of the following:
      • require supporting safety and/or efficacy data
      • have not been previously registered as an OTC medicine following down-scheduling
    • N5 New medicines that are not generics


    Slide 11 - Processes for NEW medicine applications

    • Processes for NEW medicine applications
      • New OTC applications for codeine replacement (codeine-free) products:
        • Application to be submitted to OTC and evaluated as usual (according to standard OTC procedures)
      • Applications to register new OTC codeine containing products received before 1 February, 2018:
        • Application is to be submitted via the OTC ePortal (OTC data requirements apply). PI required for both S2 and S3 products.
      • Applications for new S4 codeine-containing products received on or after 1 February, 2018:
        • Application to be submitted to PMAB and evaluated according to PMAB/SEB standard procedures. A sponsor may be able to submit an application based only on in vitro dissolution data given that codeine is likely to be highly permeable and soluble ('BCS Class I': JPharmSci 103: p1592 2014]

    Slide 12 - The Registration Process

    A submission to register a new prescription medicine is supported by:

    1. Quality data: for both the drug substances (drug master files etc) and for the dosage form
    2. Nonclinical data (if required)
    3. Clinical data: might be evidence of bioavailability (i.e. the extent and rate of release from the dosage form: in vivo or sometime in vitro)

    data required outlined in the Australian Regulatory Guidelines for Prescription Medicines (ARGPM)

    Evidence of Good Manufacturing Practice is required.

    Slide 13 - Changes to Registered Medicines: Label requirements

    For S4 medicines

    Slide 14 - Label approval

    • To allow you to use up existing pre variation stock, the date of effect of this approval, and the date from which the varied product may be supplied, is that date on which all pre variation stock:
      • which is currently in storage in Australia, and
      • for which you have placed orders prior to the date of this letter has been supplied.
    • If these arrangements cause you difficulty, please nominate an alternative date of effect for the delegate's consideration (prior approval will be required for alternative arrangements).
    • However the date of effect of this approval is no later than 31 January 2018.
    • The conditions concerning date of effect and supply of post-variation stock are also decisions under subsection 28(3) of the Act.

    Slide 15 - Supply of remaining OTC stock after 31 January 2018 - Management of ARTG entries

    Regulatory options for up-scheduling

    Dr Mayada Kayali
    Complementary & OTC Medicines Branch
    Medicines Authorisation Division

    Slide 16 - Supply of remaining S2 & S3 stock after 31 January 2018


    1. Product already supplied and out of sponsor's control (at retailers' shelves)
      • OTC vs S4 labelling requirements
      • Role & responsibilities of TGA vs S&Ts
      • Subject to discussions with S&Ts: application of dispensing labels. Existing S2/S3 labelled retail stock can be supplied by pharmacies (as Prescription Only Medicine) with a dispensing label that is compliant with Appendix L of the SUSMP and with a sedation warning
      • Exemption from S&Ts if signal heading is not changed
    2. Product has not been released for supply and/or is still the sponsor's responsibility
      • must be re-packaged with Rx/ S4 labels (sponsors can't release for supply products that don't comply with S4 labelling requirements)

    Slide 17 - Supply of remaining S2 & S3 stock after 31 January 2018

    RASML update (effective 1 July 2017)

    • RASML 3 is being updated to remove new statement
      "If coughing persists …"
    • No RASML-related changes required when RASML 3 is effective

    Slide 18 - Supply of remaining S2 & S3 stock after 31 January 2018


    • Before 1 Feb 2018: pre-approval required (current process applies)
    • Advertisement should not refer to impending changes in scheduling (could cause fear & distress.., TG Advertising Code refers)
    • Can't advertise after 31 Jan 2018
    • Ensure no publication or broadcast, including on internet & social media. This also includes advertising in pharmacies
    • Brand-based advertisement should be made specific to OTC medicines

    See TGA website for recent publication: Changes to advertising for medicines containing codeine

    Slide 19 - Management of ARTG entries

    ARTG scheduling status on 1 February 2018:

    • Will change from S2/S3 to S4
    • Area flag: will change from OTC to Rx
    • Ingredient database: will be updated to reflect availability of codeine as a RX ingredient only

    Slide 20 - Management of ARTG entries

    Annual fees

    • Paid OTC annual charge for 2017-18 covers the full financial year
    • Rx annual charge applies to 2018-19 financial year (due on 15 Sept 2018)
    • Rx annual charge applies to a medicine kept on the ARTG but not supplied (unless had the ACE status before 1 Feb 2018)
    • If already on ACE, ACE will be transferred, but you need to submit $0 turnover declaration for 2016-17 and 2017-18 by 22 July 2017  and 22 July 2018 respectively
    • Cancelling a product latest by 30 June 2018: no annual charge for 2018-19
    • Cancelling a product after 30 June 2018: Rx annual charge payable for 2018-19
      • Currently, OTC annual charge is $1,410, Rx annual charge is $3,180 (to be increased by 1.65% from 1 July 2017 subject to regulation amendment)

    Slide 21 - Management of ARTG entries

    Management of ARTG entries

    Cancelled products

    • Sponsors & wholesalers will not be able to conduct further supply of cancelled products*
    • Can't advertise if not on the ARTG
    • Already supplied and out of sponsor's control (at retailers' shelves):
      • Must dispense as Rx as of 1 Feb 2018
    • Labelling: as under Labelling
    • Sponsor's responsibilities maintained for life of product, e.g. for pharmacovigilance activities, recall action, ongoing stability testing on retention samples as per GMP requirements, providing info to the TGA on request, etc.

    * Supply of a cancelled product by retailers: the regulation of therapeutic goods is a co-regulatory scheme between the States and Territories. A person dealing with therapeutic goods must comply with all Commonwealth and State laws. You should review the relevant State laws regarding the supply therapeutic goods that are no longer included in the ARTG (cancelled products).

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