Types of Protected Data
Applicants are now required to check for the existence of any relevant protected data with respect to their applications. Where relevant protected data exists, applicants will need to demonstrate that the necessary access to the protected data has been given. There are currently three types of protected data.
- Chemical Review
- Trade-Related Aspects of Intellectual Property Rights (TRIPS)
- Application Protected Data
As a result of Chemical Reviews undertaken by the APVMA, the following active constituents and products containing these active constituents have associated protected data:
Australia is a signatory to the World Trade Organisation agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). As a result, the APVMA provides five years protection to information provided with an application for approval of a new active constituent made between 1 April 1999 and 1 January 2005.
A list of the active constituents subject to TRIPS protection. When making an application to the APVMA for active constituent approval that is reliant on a reference active constituent, applicants are required to check if TRIPS data protection is relevant. If TRIPS does apply, prior to making the application to the APVMA applicants are required to arrange consent from the approval holder of the reference active constituent for the use of the protected information.
Application protected data is the APVMA term used for data protected under the scheme associated with the US Free Trade Agreement. The scheme commenced on 1 January 2005.
A list of any application protected data associated with a product (or active constituent) can be accessed via the ‘PUBCRIS' product search facility. The list includes the data reference details and specifies the number of the application to which it is related. Direct linkages from the data list to application Advice Summaries will be added during future PUBCRIS upgrades. However at the present time, should users wish to view a relevant Advice Summary, it is necessary to manually search the Advice Summaries list, by the product and application number. Advice Summaries are published where the APVMA relied on advice given by a person, body or Government that the APVMA consulted, to make a decision to grant an application.
When making an application to the APVMA that is reliant on a reference product (or active constituent*), 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). If protected data exists that is relevant to the application (for example, relevant to a use that is proposed to be imaged), prior to making the application to the APVMA, applicant’s are required to arrange consent for the use of the protected information. The contact details for the authorising party (the data owner) for each piece of data are included in the PUBCRIS data list. Consent for use letter templates are available from the Application Requirements page.
*only applicable to applications for new active constituents, referencing an existing active constituent approval.
For more information, please contact:
Application Management and Enquiries Team
Phone: +61 2 6210 4701
Fax: +61 2 6210 4721