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4.1E Veterinary Biologics Program Service Standards (Response Times)

The response times shown below are the target response times for processing submissions within the Canadian Centre for Veterinary Biologics (CCVB). Response times are in calendar days and are calculated from the date complete applications are received. The CCVB's performance target is to process 90% of submissions within the timeframes defined for each application type.

Review of a new product licensing submission

Licensing submissions must conform to the CCVB's requirements, as specified in Guideline 3.1: Guidance for Preparation of New Product Licensing (Registration) Submissions for Veterinary Biologics. Submissions with major omissions will not be reviewed.

The target to complete the initial review of a licensing submission and prepare a response is 150 days (regardless of country of origin).

The target to review supplemental data and prepare a response is 42 days.

Issuance of permits, licences and export certificates

The target for issuing export certificates or permits to import veterinary biologics for investigational or emergency use is 14 days from receiving the completed application, fees and supporting documentation.

The target for renewing annual import permits, product licences and establishment licences is that the renewal will be done before the expiry date if the renewal application is received at least 14 days prior to expiry.

Note

Annual import permits expire on April 30. Annual product and establishment licences expire on May 31. If appropriate, these are renewed before the expiry date each year.

Serial release

If serial or batch samples are not tested, the target for review of test results and serial release is set at 14 days.

If serial or batch samples are tested, the target for review of test results and serial release is to be determined at the time of submission of the serial for testing.

Labelling review, major changes (with supporting data)

The target to review label revision submissions when there is a major change to the label is 70 days. Major changes generally require the review of supporting data, such as data to support a new label claim or a change to the directions for use.

Labelling review, no major changes

The target to review label revision submissions when there are no major changes to the label is 28 days.

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