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ACVM Applications – Smart Track

The ACVM Group has set up the Smart Track process for applications that require very limited regulatory appraisal. Based on simplicity and data appraisal required, the Group determines which applications are suitable for Smart Track. Applications that follow this route are processed more quickly and fees are greatly reduced.

Important points

• The Smart Track process will not normally be used for new registrations unless the product is identical to one currently registered.

• No new certificate will be issued unless a registration renewal is required. (A registration renewal will usually only be completed if either the applicant requests it or the registration is about to expire or is within 6 months of its expiry and all the appropriate information is provided.) Therefore, this means that the registration expiry is unchanged from that stated on the current certificate.

• A new product datasheet (PDS) does not need to be submitted unless:

- There have been changes in a number of other areas of the product datasheet apart from manufacturer. Changes in other areas need to be stated and, if necessary, approved when the application is submitted.

- The registration is due to be renewed or you wish to have it renewed and changes have been made to the PDS since the last renewal.

- A new registration certificate is required and changes have been made to the PDS since the last renewal.

• A copy of the label is not required unless there are proposed changes from the approved content.

Applicants who believe their application may be suitable for this route should complete the appropriate Smart Track form (see below for links). Even if the ACVM Group determines that the application is not appropriate for Smart Track, the supply of completed Smart Track forms should mean a more streamlined application process because less clarification will be needed during regulatory appraisal.

Smart Track fees

For approved creditors an invoice will be included with the decision advice letter. For non-approved creditors the fee must be included with the application request.

Fees are listed on the website (http://www.nzfsa.govt.nz/acvm/publications/fees/index.htm).

Multiple applications

Multiple applications refer to applications where the identical change is to occur for a number of registered products. If there are no additional areas of concern that need to be considered for individual products within the group and they require limited regulatory appraisal, then they may be considered appropriate for Smart Track.

For multiple applications the operational cost and the appraisal time will increase. The difference in charges will reflect the increase in time associated with processing a number of products under the one application. Given that the number of products under consideration may vary, there is no set fee. Therefore, if you are not an approved creditor you will need to contact us regarding the accompanying fee prior to submission of the application.

Guidance and forms for Smart Track applications

For Plant Compounds

For Veterinary Medicines

For Vertebrate Toxic Agents