Applications without written consent for reference products

As part of the ongoing review and improvement of registration processes the APVMA identified a number of applications where written consent to use the confidential commercial information for reference products was not provided.

Consent is required from owners to access confidential commercial information such as formulations or specifications, and written consent is a requirement under the Agvet Code.

Who is affected?

People with applications using reference products where no written consent has been provided are potentially affected—both pre and post 1 July 2014 applications.

Processing of all affected applications was suspended while the APVMA identified which could continue to be progressed and which require action from the applicant.

Applications were reviewed to see whether:

  1. written consent was required for the application to progress, or
  2. the statutory criteria could be satisfied by other material in the application

After review all applications able to satisfy the criteria without requiring written consent were immediately progressed.

What can applicants expect from the APVMA?

Applicants will be provided as much assistance as possible, including providing as much time as possible (within legislative constraints) for consent to be obtained. For applications that require written consent, people are notified in writing of the steps they need to take for the application to progress—from 12 September 2014.

  • Applicants will be provided the opportunity to:
    • Provide written consent from the owner of the information for the reference product
    • Provide additional argument or information
    • Withdraw their application
    • Request a deferral of consideration
  • Applications started in the online system, but not yet submitted, will also be written to and reminded of the requirements for using reference products.

What action is the APVMA taking to support industry

  • Information throughout the regulatory guidelines and on the website has been reviewed and strengthened to make it clearer that applications relying on reference products to meet the statutory criteria require written consent.
  • The online decision tree and application have also been reviewed and updated to include specific references and guidance to ensure people are aware of the requirement to provide written consent for reference products when they are preparing an application.
  • An agency-wide review of the management of official information is underway, including access to confidential commercial information, as well as physical and electronic security and information management systems and practices.
  • APVMA processes have been updated to include very specific checks for all requirements at the time applications are lodged.
  • Detailed guidance material is being developed about managing official information, including confidential commercial information.

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