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Gazette APVMA 12, 6 December 2005 page 27
NOTICEData Protection Presentation of Data
The APVMA has recently had experience with information (specifically studies and experimental reports) being submitted with applications for approval, registration or variation, with sections of the information obscured or blanked out. It is understood that the purpose of the blanking out (obscuring) is to allow certain information contained within a report to be provided at a later date and to gain protection in its own right at that time. The purpose of this notice is to communicate the APVMA’s policy on this practice.
The APVMA does not consider that the blanking out of details within a study or report is acceptable as it has no way of determining if the hidden information is relevant to its consideration of the study or report. Additionally, the obscuring of information may affect the APVMA’s confidence in the study, or ability to understand and interpret the study, potentially to the point where the study is not able to be relied on in making a regulatory decision (meaning the study would not gain protection).
With regard to the title nominated in the application data list for the items of information provided, it is the APVMA’s position that this must be the original unedited title given to the item of information by the author. This is standard citation convention.
Where studies, reports or alike are submitted with sections of information obscured, the APVMA intends (being aware that other information may exist) to exercise it’s discretion under section 159 of the Agvet Code to require the applicant (or interested person) to provide the full study text, in order to be satisfied that the obscured information is not relevant to the application at hand, or to it’s assessment of the study.
It is appreciated that the objective of obscuring certain information contained within a report may be to hold back information related to other formulations or compounds, for which registration may be sought at some time in the future (to enable a fresh protection period for the previously obscured information). For the reasons outlined above this is not practicable. Applications containing studies or reports with obscured information will be treated as deficient until the complete document is provided.
For further details on any data protection matters, please visit the APVMA’s data protection web page at http://www.apvma.gov.au/registration/data_protection.shtml. Comments on any data protection matter can be forwarded to:
Dr John Paul
Manager, Data Protection Unit
Legal and Governance Program
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604
Phone: (02) 6272 4405
Fax: (02) 6272 5811
Email: john.paul@apvma.gov.au