Consent for Use of Protected Information
Where reference products or active constituents are relevant to an application, applicant’s are required to use the PUBCRIS facility to check if there is any application protected data associated with the reference product or active constituent. Where relevant protected data exists applicants must ensure the APVMA receives the required consent for use from the appropriate authorising parties to allow the APVMA to access the protected data for the application at hand.
The following templates must be used to authorise the APVMA to use protected information in its evaluation of applications.