This content is current only at the time of printing. This document was printed on 8 December 2019. A current copy is located at https://apvma.gov.au/node/11961
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Requirements for consent to rely on confidential commercial information for reference products
NOTICE: This document is no longer current and has been retained for historical purposes only
The APVMA has received a number of requests to further explain the requirements for obtaining consent for confidential commercial information (CCI) for reference products.
This note provides more background to the requirement and outlines alternatives for applicants if they don’t have consent to use CCI material.
Types of protected data managed by the APVMA
There are three types of data managed by the APVMA that is subject to some form of protection:
- CCI defined under Section 3 the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code)
- Limited Use Information which refers to information that is subject to limitations or restrictions on when and how APVMA officers may use the information under the Agvet Code. Specific limits are defined in a number of sections of the Agvet Code.
- Other confidential information under general law.
The requirement for consent for the APVMA to access CCI is independent of any consideration on Limited Use Information.
Consent for use of CCI
The action taken by the APVMA in recent weeks relates to the handling of CCI defined under Section 3 of the Agvet Code.
Examples of information that is generally considered to be CCI are:
- The formulation, composition, specifications and manufacturing process of a product
- Manufacturing details of the active constituent and its composition
- Details of the site of manufacture of a product.
For some application types, applicants are relying on saying their product is ‘closely similar’ to a product that is already registered (known as a reference product) in order to satisfy the safety, efficacy and trade criteria by which the APVMA must assess each application. Some applications rely on a comparison of the formulation for the product to be registered against a nominated reference product, with no other information provided.
Section 162 of the Agvet Code places clear restrictions on the direct disclosure (disclosing the actual CCI) and the indirect disclosure (disclosing information which effectively discloses the substance of the CCI) of CCI by the APVMA.
In line with the introduction of the new legislation from 1 July, 2014 and the ongoing implementation of the Government’s Protective Security Policy Framework, which requires agency heads to have systems to safeguard information held by government, the APVMA has clarified and updated the process for dealing with CCI.
Alternatives to consent
One option for applicants would be to obtain consent from the owner of the CCI for the APVMA to use and disclose the CCI in consideration their application, however, it is recognised this may not be possible.
Alternatively, there are ways of addressing the relevant statutory criteria which do not require access to the CCI of a reference product, including (but not limited to):
- Provide evidence that the information on which you are relying is in the public domain, for example on a website, in a MSDS or the APVMA register. If the information is available publicly, it is not CCI, and no consent is necessary.
- Submit data or other information to make a scientific argument as to why your product and the reference product are closely similar and meets the statutory criteria. This could involve a comparison of label uses.
- Establish bioequivalence between the two products. There are a number of international guidelines for bioequivalence that the APVMA will accept.
- Undertake independent data trials.
Over coming weeks, the APVMA will be issuing more detailed guidelines for different types of products.
For more information and assistance
If you have an application in the system that is impacted by the CCI requirements, you will have received, or will shortly receive, a letter from the APVMA outlining what you need to do and contact information should you wish to discuss the issue further.
If you decide to withdraw the application, you may request a refund of fees paid. Each request will be determined on a case-by-case basis.
If you are yet to submit an application, look at the information on our website or contact the APVMA using the Pre-application Assistance scheme. Until 12 December 2014, the APVMA will remit the initial $350 fee for applications for pre-application assistance relating to looking at alternatives to providing consent.
The APVMA has prepared guidance material on its approach to managing CCI.
Chief Executive Officer