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Transition Project Update - The Concept of 'Responsive Transition'

A large proportion of ACVM Group activity is focused on regulation and registration of generic products. Once the ACVM Act and HSNO legislation come into effect, new applications will be assessed under the HSNO legislation, while existing trade name products in groups will be transitioned from the Animal Remedies Act to the ACVM Act by regulation. If they are hazardous substances the regulations to transfer products to the HSNO Act will be done at the same time.

This presents an anomaly in that generic products will be provided with a HSNO approval number only after transition of other products in the same group by regulation has occurred. The process is likely to be dependent on the sequential assessment of substances and the promulgation of regulations, a process which might take some years.

It is likely, then, that a generic manufacturer would either have to make application as if the compound were a novel active, or wait until the substance being substituted was put through the transition process. Both scenarios could add significantly to the cost and timing of getting generics to the market, and may impact on the future viability of the process.

One solution to this dilemma would be to ensure that the timing of transition coincides with a generic application being made within a reasonable time-frame. The product/substance is to be transitioned anyway, by regulation, and this process will continue regardless, so the costs of transition are not placed on the applicant.

A suggested solution was recently endorsed by AVMAC. The ACVM Group will discuss this with ERMA New Zealand to see if it is workable because it is recognised that the need for the transition to be effected by regulation (to both the HSNO and ACVM Acts) will add complexities.

The suggested solution is as follows:

As the ACVM Group is unable to predict which substances are likely to be the subject of generic application, a system of ‘responsive transition’ could be implemented.

Should there be an application for a generic product in transition, then the ACVM Group should be able to transition that group of substances from the Animal Remedies Act to the ACVM Act, gaining a HSNO approval number within a time-frame similar to that of the current approval process. This would require an agreement to be drawn up between the ACVM Group and ERMA New Zealand.

If this system is implemented, it is likely that the great bulk of future ACVM approvals could proceed, and the ability to manage the various ACVM risk areas will be maintained at minimal additional cost to New Zealand.