About July 2014 the Australian Pesticide and Veterinary Medicines Authority’s (APVMA) introduced severe restrictions on the use of confidential commercial information (CCI) required to access new product registration. This has caused uproar throughout the Australian agchem and veterinary medicine industry. Eureka! AgResearch probably has as much involvement with the APVMA as any company in Australia.  At any one time about 30 or more products we have developed are in the process of being registered by our clients. Data and quality scientific arguments have become far more valuable. We have often been complimented by APVMA staff on the quality of the scientific arguments that we compile to support registration applications. With our considerable experience in the use, application, formulation and mode of action of these chemicals, it is little wonder that we can construct convincing arguments.

In short, the new changes at the APVMA to the use of CCI may be confusing but we can recommend alternative pathways to support your product registrations.

The treatment of CCI has long been a difficult balance for the APVMA. On the one hand they must consider the rights of companies that provide confidential data. On the other hand, there are the legitimate rights of companies wanting to take advantage of registering a product that meets the definition of being “similar” to a registered product.

In the past, an application under Categories 5, 6 or 7 referenced a registered product that it claimed to be similar to. The APVMA allowed their examiners to review confidential data submitted in support of the original product’s registration to determine whether the application was sufficiently similar to meet the criteria of the Category. If it was essentially identical it was Category 7 if it was less similar then it would drop back to a Category 6 or even 5. If it was not similar enough for a Category 5 it usually ended up as a Category 10.

The APVMA will no longer consult any confidential data without the approval of the owner of that data. Whilst most of our clients understand the arguments behind the change some are furious about how the changes were made without previously informing the industry.

Our phones and those of registration consultants around the country have been running hot as companies try to comprehend these changes and decide what to do. Eureka! has guidelines to assist our clients.

If you do not have access to a letter of support from the owner of CCI when applying for registration of a similar product then you are not likely to succeed with an Item 6 or 7 application (formerly a Categories 6 or 7).  However, there are two options still available. It has always been an applicant’s right in an Item/Category 10 application 

Dyno LabMill

Figure 1. A chemist from Eureka! formulates a 5L batch of suspension concentrate in our Dyno® LabMill, pilot plant.  This sample will be used to generate the data required in a Chemistry and Manufacturing data pack for the APVMA.

to bring the reviewers attention to the fact that the proposed product is similar to a number of reference products. Should this application be approved the applicant does not know which dossiers, if any, were inspected by the reviewer and so no confidential information can be claimed to have been divulged. To some extent a similar argument can be used with an Item 5 application. Both the Item 10 and Item 5 applications are likely to require Chemistry and Manufacturing data packages. This presents no problems to us at Eureka! as we have the extensive range of laboratory equipment and pilot plants needed to collect this data.

Although we can write compelling scientific arguments it is important to emphasise that we are not registration consultants. Australia and New Zealand are particularly fortunate in the quality of their registration consultants and you should seek their advice on APVMA issues. We are always happy to work closely with consultants to ensure that our mutual clients are looked after.

If you have products requiring registration or product ideas that are stalled because you are confused about the new APVMA requirements, please Anthony Flynn 

Written By: Anthony Flynn
© 2014 Eureka! AgResearch Pty Ltd