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Regulation impact statement: Codeine re-scheduling

Version 1.1, December 2016

20 December 2016

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Implementation timeframe

The implementation timeframe for any decision that impacts on labelling, pack size or scheduling has the potential to increase regulatory costs. The cost estimates outlined in the reminder of this section assume an implementation timeframe of 18 months. However, it is important to note that a change in timeframe would impact the estimated costs. For example, a shorter implementation timeframe may mean that sponsors cannot make the necessary changes in time (or obtain the necessary approvals), which, in an extreme case, could require products to be removed from the shelves, or may mean that revised products cannot come to market by the time existing products are withdrawn. A longer implementation timeframe may enable a greater proportion of compliance activities (such as a labelling update) to be rolled into other scheduled changes thereby reducing the compliance burden, while also enabling sponsors who are adversely impacted to reposition themselves to adjacent markets.

There are several categories of changes which are impacted by implementation timeframes:

  • time to implement labelling changes (compliance).
  • time to reduce pack sizes (compliance).
  • TGA approval timeframes (approvals).
  • stock recall (compliance).
  • product strategy and portfolio diversification (business).

Figure 7 below illustrates indicative implementation timeframes for each of these categories.

Figure 7

Figure 7: Implementation timeframe

Labelling changes

Consultation has identified that the implementation of labelling changes will take between 6-8 months. The component steps involve the development of artwork, internal approvals, regulatory approvals and implementation. This falls within the 18 month transition window provided by the TGA for recent RASML updates.[133]

Stock turnover

Consultation with manufacturers has identified stock turnover timeframes of between 6 weeks and 4 months. Different parts of the supply chain will hold different levels of stock. Codeine based products have a shelf life of 24 months, although this is not anticipated to be a constraint, given the level of turnover.

Product strategy and diversification

In response to a decision, manufacturers and retailers who currently have a market share of codeine-based products will have a planning and investment timeline to reposition their product portfolio. Some sponsors may require registration of new ARTG entries that have a 12 month lead time. Following this, manufacturers may require up to an additional 6-12 months to assemble the production line and source materials. This will vary depending on whether production is local (increased flexibility), or overseas (less flexibility). An 18-month timeframe would be ideal to allow impacted manufacturers (and to a lesser degree sponsors) to reposition, and therefore maintain, their market share.

Reduce pack size

Manufacturers who do not have existing production lines that can accommodate a reduced outer pack, or inner blister pack, will need to make changes to their production line. Discussions with manufacturers have indicated this would take 9 months from procurement to implementation. In the event that this is not commercially viable, sponsors could seek an alternative manufacturing site. Although in the event that the alternative site does not have GMP certification this may be a lengthier process.

OTC C1/C2 level applications

The anticipated timeframes for approval of C1/C2 change applications are approximately three months.[134]

Applications to register a prescription medicine (Schedule 4)

Any up-scheduling of Schedule 2 and Schedule 3 medicines to Schedule 4 would not require the registration of new prescription medicine, as codeine is not a new ('novel') chemical entity. In the case of Schedule 3 medicines up-scheduled to Schedule 4, the processes for minor variations to registered prescription medicines would be followed. This would entail the submission of a Category 3 application (with an associated processing timeframe of 45 working days). Specifically a '9D(3) Category application to vary an ARTG entry' would be used with the existing PI and CMI submitted with the application. For Schedule 2 medicines up-scheduled to Schedule 4, a new PI and CMI would need to be produced (though these could leverage existing PIs and CMIs for medicines with codeine as an active ingredient). This would be considered a Category J variation ('Changes to product information requiring the evaluation of data'), with a maximum processing timeframe of 255 working days (Category 1 application). However, that as this application does not relate to a new chemical entity or a new indication(s) that the actual processing time (and associated data requirements) is likely to be considerable less than this. The standard process to register a new prescription medicine is estimated to take between 12 and 24 months. However, codeine is already an established active ingredient and is included in many OTC and prescription medicines already in the market.

The implementation timeframes for each option are summarised in Table 21. Outlined for each option are the associated constraints and the minimum time required for option implementation, in addition to industry preferred timeframes.

Table 21: Summary of implementation timeframes
Minimum implementation timeframes Desired timeframes by industry

Option 2

Add warning label and reduce pack size on Schedule 2 products

9 months

Constraint: packaging changes (overseas)

12 months

Option 3

Up-schedule Schedule 2 to Schedule 3, and add warning label and reduce pack size

9 months

Constraint: packaging changes (overseas)

12 to 18 months

Driver: product strategy and repositioning

Option 4

Up-schedule Schedule 2 products to Schedule 4

12 months

Constraint: regulatory approval

18-24 months

Driver: product strategy and repositioning

Option 5

Add warning label and reduce pack size on Schedule 3 products

9 months

Constraint: packaging changes

12 months

Option 6

Up-schedule Schedule 3 to Schedule 4

12 months

Constraint: regulatory approval

18-24 months

Driver: product strategy and repositioning

Source: KPMG report, Table A4

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