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AgVetLink: Number 63, August 2007

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.

Quicker, cheaper...

Applications that follow this route are processed more quickly and fees are greatly reduced. The development of this process recognises the concerns expressed by registrants that minor variations to registrations resulted in a disproportionate cost and effort compared with major applications.

The new process allows suitable applications to be dealt with during the existing pre-screen, which occurs on the receipt of an application.

Not normally for new registrations

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

A new registration certificate will not be issued unless a registration renewal is required. A registration renewal will usually only be completed if the applicant requests it or the registration is about to expire (or is within six 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.

Information required

For any simplified system to work effectively it is important that the basic information required is submitted the first time.

Forms have been developed for each application type to assist with the processing of the application and to make it easier to identify the information required. Applications that are not made on the standard forms will be processed, but this may result in extra time and costs.

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

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

b. 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

c. 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.

The complete details on the process and application forms are available on the ACVM website.