Gazette APVMA 6, 6 June 2006 page 27

NOTICE

Data Protection

Demonstrating consent for use by resubmission of data

Data protection is applicable to information provided to the APVMA in connection with applications made after 1 January 2005 for registration or approval, or to vary an existing registration or approval, if the information is required and subsequently relied on to grant the application. Further, the APVMA must be satisfied that it does not hold identical information whose use is not limited. Information that is provided in connection with an application that is not required by the APVMA for the purposes of assessing the application, or is not relied on to grant the application* is not eligible for protection under the current provisions. Consequently the use of such information is not limited **.

The APVMA has recently had experience with information being resubmitted in connection with non-technical ‘image’ type applications. These applications can be made under categories 6, 7, 8 and 12 and involve the copying or ‘imaging’ of claims from an approved reference label. The data has been resubmitted to demonstrate consent for use of the information, instead of providing a consent for use letter from the authorising party for the information. As the purpose of most non-technical ‘image’ type applications is not to conduct a technical assessment of any new data but rather to copy a claim between ‘similar’ or ‘same’ products, the information resubmitted in connection with the subsequent image application is not required for the purpose of the application. The impact of this is that the copy of the information that has been resubmitted with the subsequent image application is not eligible for protection and its subsequent use by the APVMA is not limited, ie it can be referenced without consent. Whilst it is apparent that this is not the intent of the applicant, it is the effect of the current legislative provisions.

To avoid unintentional effects on the protection status of information, the APVMA advises authorising parties to exercise care when providing information to third parties to be submitted in connection with an application to ensure that the information is only submitted where it is required for the application. Once the APVMA holds a copy of a particular piece of information whose use is not limited, data protection is no longer applicable to that information, even if it was required and relied on previously.

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

* Including information submitted in connection with applications that are refused or withdrawn
** Refer to sections 34C and 34D(5) of the Agvet Code