Companies seeking to register a new pesticide or veterinary product in Australia should note the new guidelines published by the Australian Pesticides and Veterinary Medicines Authority (APVMA) which relates to the access and use of information held by the APVMA. This is particularly the case if they wish to rely on an already registered product as a “reference product” in order to satisfy the application criteria.
All agricultural products and veterinary medicines must be registered in Australia by the APVMA. As part of the application process, applicants are required to provide information to satisfy the APVMA that the statutory criteria has been met (including the safety criteria, the efficacy criteria and the trade criteria). Much of the information provided by applicants will have various statutory protections against further use and/or release by the APVMA, including information which falls within the definition of “confidential commercial information” (CCI).
The APVMA has recently published new guidelines about how it will identify, use and disclose information held by it, including information that may be CCI.
The changes to the APVMA’s practice impact upon new applications which seek to satisfy the statutory safety, efficacy or trade criteria by relying on that product being similar, closely similar or the same as an already registered or approved product (reference product).
Applicants seeking to nominate a reference product, and rely on material related to that reference product, in order to register a new product must now either:
- obtain and provide to the APVMA consent from the holder of the registration or approval for the reference product (or the party which “owns” the relevant information, such as the manufacturer); or
- provide all information necessary to establish that the relevant aspects of their product are similar, closely similar or the same as the nominated reference product (for example, by providing further copies of the reference product material properly obtained from the owner of the material, or by providing new, independently sourced material); or
- provide evidence to the APVMA which demonstrates the material held by the APVMA about the reference product is not CCI (for example, because it is available in the public domain).
The form of consent will be important. Companies seeking consent should ensure that it is in writing, identifies the information in question and expressly allows the APVMA to access, use and disclose that information. On the other hand, companies who receive a request to provide their consent should ensure that it specifies any limitations that apply to the consent (for example, the consent may only allow the use and disclosure of the information to the APVMA to the extent that it is necessary to determine the application in question or may allow use by the APVMA but prevent disclosure of the material to the applicant).
Applicants should refer to the guidance available on the APVMA’s website to ensure they are in line with the updated requirements and review the changes before lodging any application which seeks to rely on material related to a nominated reference product. Click here for further details.