Making changes to veterinary products and actives—clarification for industry

Issues

• For some years the APVMA has not allocated separate active approval numbers for veterinary actives.
• In practical terms this has meant that variations to relevant particulars and conditions for veterinary actives could not be made by making an application under an item number—because that requires a separate active approval number—and that these types of changes were being made using section 161 of the Agvet code.
• In addition, as part of considering how to address the first two issues, the APVMA has identified a third issue which is the need for greater clarity around the types of changes that are required to be submitted to the APVMA and the correct mechanism by which to make these changes.

Action taken to address the issues

Active approval numbers

All actives require a unique approval number under the Agvet Code and we are currently undertaking an administrative exercise to assign existing vet actives an approval number and to update the APVMA chemicals database to reflect this.

The APVMA can issue an approval number in the meantime should one be required for a variation application.

Gazetting of the approval numbers commenced in December 2015 and the process is expected to be completed in the first half of 2016.

Requests for changes currently on hand through 161s

All requests on hand will be reviewed to determine whether the changes relate to a relevant particular or condition. If this is the case we will work with the holder to facilitate the appropriate variation application.

As a transition measure, we will waive or refund all or part of the fees associated with Item 18 applications until the end of June 2016. There will be no cost to applicants for variations where the APVMA redirects the change request to an application item from an existing section 161 notification.

For any new variations that come in under Item 18 (until end of June 2016), we will determine the refund on a case by case basis, as it will depend on the level of assessment required to make the variation.

If the information does not relate to a relevant particular or condition, it will be assessed to determine whether it is relevant information under section 161.

Improvements to website information

We have reviewed and improved the website content to make it clearer which mechanism to use for different types of change, including:

• changes to relevant particulars and conditions—variation application
• minor changes—a notifiable variation application
• reporting new relevant information—in writing using s161

If the change does not fall into the above categories then you are not required to advise the change to the APVMA.

Assistance for applicants

This is a major exercise and will take time to work through. Anyone who requires an urgent variation can contact us directly and we will give priority to these applications where possible.

All applications are being managed through one team who can be contacted by emailing vetactives@apvma.gov.au or telephone 02 6210 4984 directly.