You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

Codeine rescheduling - information for sponsors

24 February 2010

Introduction

The National Drugs and Poisons Schedule Committee (NDPSC), at its June 2009 meeting made the following resolution:

RESOLUTION 2009/56-8
The Committee decided:

  • that the current scheduling of codeine combinations for coughs and colds remained appropriate
  • that OTC combination analgesics containing codeine (CACC) be removed from Schedule 2
  • to limit the duration of treatment for OTC CACC to no more than 5 days
  • to limit the maximum unit dose of codeine in OTC CACC to no more than 12 mg
  • to limit undivided OTC CACC preparations to no more than 5 days supply at a maximum daily dose of 100 mg and at a concentration of no more than 0.25 per cent
  • to limit the maximum daily dose of codeine in OTC CACC to no more than 100 mg
  • not to include codeine in OTC CACC in Appendix H, and
  • to defer implementation of this resolution until 1 May 2010.

Information on the background and reasons for this resolution appear on the TGA website at: NDPSC record of reasons, 56th meeting 16-17 June 2009.

In October 2009, the NDPSC varied this resolution to the following:

RESOLUTION 2009/57-14 (variation to Resolution 2009/56-8)
The Committee confirmed the June 2009 resolution (2009/56-8) regarding a Schedule 3 entry for all OTC combination analgesics containing codeine. However, the Committee agreed to vary the June 2009 resolution (2009/56-8) regarding the Schedule 2 entry for codeine combinations for coughs and colds by increasing the pack size limit to not more than 6 days (rather than 5) of supply as the maximum dose recommended on the label.

Schedule 2 - Amendment
CODEINE - Amend entry to read:
CODEINE in preparations for the treatment of coughs and colds when:

  1. not combined with any other opiate substance
  2. compounded with one or more other therapeutically active substances, of which at least one is phenylephrine and not more than one is an analgesic substance
    1. in divided preparations containing 10 mg or less of codeine per dosage unit, or
    2. in undivided preparations containing 0.25 per cent or less of codeine
  3. labeled with a recommended daily dose not exceeding 60mg of codeine, and
  4. in packs containing not more than 6 days of supply at the maximum dose recommended on the label.

Information on the background and reasons for the revised resolution appear on the TGA website at: NDPSC record of reasons, 57th meeting, 20-21 October 2009

These two resolutions have the effect of removing all Over-The-Counter (OTC) combination analgesics containing codeine (CACC) (other than phenylephrine-containing combinations for the treatment of coughs and colds) from Schedule 2 of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP), from 1 May 2010.

Based on these resolutions:

  • those CACC products (with the stated maximum units and daily dosage) in packs containing up to 5 days' supply (and which are not Schedule 2 ('S2') medicines) will be transferred to Schedule 3 ('S3' - Pharmacist Only) of the SUSDP, and
  • all packs containing more than 5 days' supply (and that are not S2 medicines) will be reclassified as Schedule 4 ('S4' - Prescription Only) medicines.

It is a regulatory requirement that all medicines included in Schedules 3 and 4 of the SUSDP have product information (PI) and consumer medicine information (CMI) documents. Given the timeframe for implementation of the changes and the numbers of products affected, the TGA has made the following arrangements, in consultation with the Australian Self-Medication Industry (ASMI) (including developing core PI and CMI - see below), to assist sponsors in making required changes for their products. The TGA has also written to all sponsors of OTC CACC medicines explaining these arrangements.

What do I need to do to update my OTC CACC medicine entry in the ARTG?

1. For an OTC CACC medicine entry in the ARTG that already has a PI document and a CMI document

Sponsors may obtain clearance for changes to signal headings for their OTC CACC medicine by way of notification (using change code 'LSU' in eBS) provided all of the following conditions are met:

  • an assurance that no aspects of the labelling, PI, CMI, pharmaceutical data or product details have been changed, other than that nominated in this application and those made in conformity with the 'Changes table'
  • an assurance that the change is in compliance with the scheduling requirement introduced in the SUSDP, and
  • copies of the current label, PI and CMI of the goods and a draft of the new label, PI and CMI with the relevant changes highlighted, have been supplied.

2. For an OTC CACC medicine entry in the ARTG that does not have a PI document and a CMI document

Sponsors may introduce a PI document utilising one of the core PI documents (see below) by way of notification (using change code 'OTN' in eBS) provided all of the following conditions are met:

  • an assurance that the product's PI is identical to the relevant core PI document for {insert specific combination} apart from the product name and other identifying details in line with the approved or validated product
  • an assurance that the indications on the PI is as specified in the ARTG, and that the dosage section is as specified on the existing product label, and
  • copies of the existing label and the proposed PI are submitted with the application.

If any of the above conditions are not met, sponsors must apply for approval of the PI.

3. For an OTC CACC medicine entry in the ARTG that is 'grandfathered' (i.e. not fully evaluated) and has never been validated through an online eBS application

For 'Grandfather' entries which have never been validated via an online application, the introduction of a PI document requires evaluation prior to approval by the TGA.

Core PI document templates

The TGA and the ASMI have developed core PI documents based on information in standard reference texts and previously evaluated and approved PIs for the following OTC CACC:

How to access an rtf document

(to use these core PI document templates, right-click on the link and save to your computer's hard drive)

These core PI documents are also available from the ASMI website.

Core CMI document templates

The TGA and ASMI have developed core CMI documents which are based on information in the above core PI document templates. These core CMI documents are for the following OTC CACC:

How to access an rtf document

(to use these core PI document templates, right-click on the link and save to your computer's hard drive)

These are also available from the ASMI website.

The introduction of a CMI will not require notification if the CMI is not a package insert, and when:

  • the CMI complies with Schedule 13 of the Regulations, and
  • the CMI is consistent with either an existing approved PI or a core PI document (see above)

It is the sponsor's responsibility to ensure that all requirements are met. If either of the above criteria is not met, the sponsor must submit an assessable application as outlined below.

Where the sponsor intends to supply the CMI document as a package insert (or one of the other criteria above are not met), sponsors may introduce a CMI document by way of notification (use change code OTN in eBS) provided all of the following conditions are met:

  • an assurance that the CMI is consistent with either a previously approved PI for the product or with a PI based on the TGA/ASMI core PI and for which application has been lodged (as above, either separately or together with this application)
  • an assurance that the CMI is consistent with the information on the ARTG and the existing label for the product, and
  • copies of the existing label, PI document and CMI document are submitted with the application.

Enquiries

Enquiries should be made to the OTC Medicines Section (freecall 1800 616 011) or email OTC.medicines@tga.gov.au.