This content is current only at the time of printing. This document was printed on 26 June 2021. A current copy is located at http://www.plural-consulting.com/node/26701
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Access to information
This section of the application is relevant to applicants who are referring to an existing Australian Pesticides and Veterinary Medicines Authority (APVMA) registered product in their application.?This is known as a reference product.
A reference product may be referred to if information that is relevant to the reference product is also relevant to the current application. This means that the applicant believes the APVMA’s satisfaction for the reference product for some or all of the safety, trade or efficacy criteria should apply equally to their proposed product.
Limitation of use period
Chemical database records identify if there is protected information or limits on use of information associated with a product.
Some registered products have limits on use of information associated with them. Applicants referencing another product to support their application will need to determine if any limits on use of information exist before making the reference. If there are limits on use of the information and it is relevant to the application, the applicant will need to obtain written consent from the authorising party (this is usually but not always the owner of the information – see below) for that information to be used by the APVMA in assessing the application.
There are other categories of information which could have some protection covering its use. These include:
- the information provided in connection with certain active constituent applications is afforded protection under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). More information on this is available on the APVMA website
- protected information as defined in section 3 of the Agvet Code which is information that has been obtained because of a trial or laboratory experiment and given in response to a notice issued by the APVMA either in the context of a reconsideration of a registration of a chemical product or approval of an active constituent or label or a possible suspension or cancellation of the same. This information is protected for an 8 year period
- our?PubCRIS database can be used to identify if there are limits on use of information/protected information associated with a product.
The authorising party is usually the owner of the data you are referencing in your application. If there is more than one authorising party, use the plus button located on the right of the screen to add additional authorising parties. More information about the role and responsibilities of authorising parties is available from the authorising party webpage.
Confidential commercial information (CCI)
We have a legal obligation to ensure there is no unauthorised disclosure of confidential commercial information (CCI) associated with a reference product and take reasonable precautions to ensure that?our staff do not directly or indirectly release such information. Please see advice for applications involving reference products for more information.
While not a requirement, applicants may opt to provide written consent from the authorising party when referencing a product or chemical that contains CCI. However, a consent letter is required if there are limits on use on the information as outlined above.
- A consent letter needs to identify:
- the authorising party – who owns the protected information
- the applicant – who is being given consent to access or use that information
- the product, chemical or approval for which use is permitted
- what the holder is granting consent to use or reference and any limits to that consent.
- This consent letter needs to be provided to the APVMA prior to making an application or within seven days of submission.
- Applicants and authorising parties are encouraged to ensure any commercial arrangements between them are negotiated prior to submitting the application.
- Once consent is given to use information which has limits on use, the APVMA is able to use the information even though the authorising party withdraws the consent or later states it has not consented.
- If information is 'protected information' as defined under section 3 of the Code, then the APVMA can only use this information if you have reached an agreement with the authorising party on the appropriate compensation for use of the protected information and have notified the APVMA of that agreement in writing.