Operational notices regarding Data Protection

Since 1 January 2005 when the Data Protection provisions came into effect, the APVMA has published a number of operational notices regarding data protection. These notices are intended to clarify and provide additional guidance on specific aspects of the data protection requirements.

Protected data information for individual products (and active constituents)

Information on how to search for protected data using the PUBCRIS database
(Gazette APVMA 11, 1 November 2005, Page 30)

Presentation of data

The APVMA’s position on the presentation of information with sections of text blanked out or hidden.
(Gazette APVMA 12, 6 December 2005, Page 27)

Applications for repacks submitted under Category 8

How formulators' declarations may provide consent for use of protected data where the formulator is the authorising party for that data.
(Gazette APVMA 6, 6 June 2006, Page 26)

Demonstrating consent for use by resubmission of data

Potential consequence of resubmitting protected data for subsequent ‘image’ applications to demonstrate consent for use.
(Gazette APVMA 6, 6 June 2006, Page 27)

Chemistry data and data lists

The inclusion of chemistry data in data lists.
(Gazette APVMA 9, 5 September 2006, Page 22)

Identifying previously submitted information in data lists

Enhancements to APVMA data lists to allow registrants to identify information that has previously been submitted to the APVMA.
(Gazette APVMA 3, 6 March 2007, Page 32)

 

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