Gazette APVMA 11, 1 November 2005 - Page 30
NOTICEData Protection
Protected Data Information for Individual Products (and active constituents)
For applications received from 1 January 2005, the APVMA is required to publish a summary of the advice received from a person, body or the Government that the APVMA has relied on in granting an application (‘Advice Summaries’). The summary must include a list of the information considered in providing the advice. Advice Summaries are available from the data protection - Page on the APVMA website (visit www.apvma.gov.au and click on "Application/Advice Summaries and DATA PROTECTION" from the menu on the left).
The APVMA has recently redesigned the product search facility ‘PUBCRIS’. This facility is available on the APVMA website (visit www.apvma.gov.au and click on "Search for a product" from the menu on the left). The new PUBCRIS provides the ability to view a list of any application protected data associated with a product (or new active constituent (1) ) . 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, accessed from the Data Protection web - Page, by the product and application number.
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 (2) associated with the reference product (or active constituent (3)). 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 data protection - Page (click on “Data Protection Application Requirements”) on the APVMA website.
For further details on any data protection matters, please visit the APVMA’s data protection webpage.
1. Note: Application protected data is only applicable to applications received from 1 January 2005.
2. Applicant’s should also be aware of Chemical Review and TRIPS data protection. For further information, please refer to the data protection - Page (click on “Current Protected Data Information”) on the APVMA website.
3. Only applicable to applications for new active constituents, referencing an existing active constituent approval.