Seeking comment on five new notifiable variation items

The APVMA is proposing to add five new notifiable variation items to remove the need for full applications for certain simple changes to product registrations and active approvals.

A draft legislative instrument detailing the proposed new notifiable variations has been released for public comment.

Background

As part of the Lower Regulatory Approaches to Registration project we are systematically reviewing our processes to identify opportunities to reduce the regulatory burden for industry—particularly where a low cost, simple administrative change can be made easily by the APVMA.

This review will lead to alternative and more efficient processes for the registration of agricultural and veterinary chemical products.

We have identified a group of simple variations to approved active constituents, registered chemical products and approved labels which could be managed as notifiable variations rather than through the traditional application pathway. The proposed new notifiable variations are:

• a variation to the address of a site at which the active constituent is manufactured by the manufacturer if there is no physical change of location
• a variation to the name of any other registered products referred to within the instructions for use on the label (provided the product has the same APVMA approval number)
• a variation to the instructions for storage and disposal of containers or products, in line with the requirements of the labelling code. But only if the variation will not result in other instructions for use being modified or affected
• a variation to safety directions and first aid instructions appearing on a label to reflect those appearing on the label of a ‘similar product’ as defined in Clause 1.2 of Schedule 6 to the regulations  
• a variation of the net contents of a veterinary product but only if:

1. the variation will not result in the instructions for use, or disposal, of the product or containers for the products, being modified or affected
2. the net contents is in the range recorded in the Register for the product.

These proposed changes are expected to be supported by stakeholders due to the reduction in regulatory burden.

Stakeholder impact

The stakeholders impacted by this proposal are the holders of registered agricultural and veterinary chemical products.

Stakeholders will no longer need to submit an applications for changes which are relatively minor in nature. This means:

• the proposed change would take immediate effect rather than being subject to an assessment timeframe of at least 3 months
• there will be a reduction in fees by making these changes using the notifiable variation process.

Draft instrument

This instrument will be made under the streamlined variation process outlined in Division 2AA of the Agvet Code. It applies to simple variations which are of minor or low regulatory concern and is intended to reduce the application requirements and timeframes placed on holders.

This instrument sets out a list of variations to active constituents, product registration and label approvals that, due to their largely administrative nature, the APVMA considers appropriate to be managed through the process of notifiable variations.

This instrument is expected to commence in the September quarter of 2016.

Implementation

At the completion of the public consultation period all comments will be taken into consideration in the revision, if any, of the legislative instrument.

The instrument and associated processes to support the proposal are expected to be in place by the September quarter 2016.

Consultation information

The APVMA is seeking feedback from industry on the draft legislative instrument to ensure it meets the needs of applicants.

The consultation is open until 29 June 2016. Following consideration of comments received during consultation, the legislative instrument containing the variations will be finalised and regulatory guidance made available from the APVMA website.

Please lodge your written submission by email, post or fax to:

Project Officer—Lower Regulatory Approaches to Registration
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Email: chemicalreview@apvma.gov.au
Fax: +61 2 6210 4776