Record Record Call-Ins
The APVMA conducts desk-based audits of the records it requires under the Conditions of Registration.
The APVMA will issue a notice requesting registrants to provide all relevant records for auditing. Registrants will have a minimum of 10 days (or sufficient time as negotiated) to collect and supply records for inspection.
These notices are issued on the basis of information received by the APVMA including adverse experience reports and non-compliance reports.
Record monitoring will only be conducted on records that are submitted. No further documents will be sought or considered. Once an audit is completed the APVMA will notify registrants in writing of the outcomes and any escalation of compliance action resulting from non-compliance.
Where the records provided by the registrant do not satisfy the Conditions of Registration, the APVMA will consider the nature of the failure, its significance, and what risks the failure may present.
Any non-conformance measures will be based on the significance of the failure and may include warning letters or the need for submission of applications to update particulars with the APVMA. In more significant matters the APVMA will consider product recall, testing orders, product suspension or prosecution.
When supplying records for record auditing registrant’s must advise the APVMA if they intend to rely on an analytical method and related validation data previously submitted to the Authority.
This advice must include the relevant APVMA file reference. It should also include:
- the analytical method number (if any) or title, OR
- the date of submission, OR
- the APVMA application number.
Where the information was provided by a third party, release from that party to access the information for the purpose of audit must be obtained.