This content is current only at the time of printing. This document was printed on 29 March 2017. A current copy is located at http://apvma.gov.au/node/581
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Data handling by the APVMA
The Australian Government Protective Security Policy Framework requires the APVMA to classify the information it receives. How that information is classified determines how it will be disclosed or accessed as well as how it is to be stored or disposed of.
Information received with an application (for example details provided in dossiers) is generally classified as sensitive—confidential commercial information. This classification requires us to securely store application information, and when using an external reviewer, send the information using commercially approved couriers who are responsible for its carriage and safekeeping or by secure email transmission.
Confidential commercial information
Section 162 of the Agvet Code prohibits the APVMA (or any member of its staff) from disclosing confidential commercial information. Confidential commercial information in relation to an active constituent or a chemical product is defined in section 3 of the Agvet Code to mean:
- a trade secret relating to the active constituent or chemical product or other information about them that has a commercial value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed; or
- information that concerns the lawful commercial or financial affairs of a person, organisation or undertaking and relates to the manufacture, distribution or supply of the active constituent or chemical product that if disclosed could unreasonably affect the owner of the information in an adverse manner.
The definition of confidential commercial information under the Agvet Code does not include information associated with making a permit application for the use of an active constituent or a chemical product, if the use proposed in the application is for minor or emergency use and includes the information prescribed by regulation 3C of the Agvet Code Regulations.
The APVMA takes reasonable precautions to ensure that its staff does not release or enable access to classified information by unauthorised people.
Separate to the concept of information being confidential commercial information some information associated with applications to the APVMA attracts protection under the Agvet Code. There are a number of different types of protection:
- Information where use is restricted under limits on use of the information under Division 4A of Part 2 of the Agvet Code (‘limits on use of the information’)
- Information where use is restricted under Part 3 of the Agvet Code (‘protected information’)
- Information where use is restricted under Part 7B of the Agricultural and Veterinary Chemicals (Administration) Act 1992
- Information protected by section 14B.
It is very important to remember that any one piece of information can be covered by more than one set of restrictions on use.
The documents or samples provided to the APVMA for any purpose under the Agvet Code do, by section 169 of the Agvet Code, become the property of the APVMA including information of any application that has been refused or withdrawn. Despite this, the information may remain confidential commercial information indefinitely.
The APVMA, as a commonwealth authority, is required to keep all documentation (paper and electronic) in accordance with the Archives Act 1983 (the Archives Act) that is administrated by the National Archives of Australia (the NAA).