In July 2014, the APVMA’s surprise changes to its product registration requirements brought some sections of the agchem industry to its knees. Six months later I am pleased to explain why confidence in product registration has returned.
Confidential Commercial Information (CCI)
Over the last six months Eureka! has written scientific arguments to support product registration for more than 30 applications. To date, not one of our arguments has failed!
A tip from Eureka! is to concentrate on using Item 10 applications. The key is that Item 10 does not require applicants to reference any other product and so bypasses the need for the reviewer to consult confidential information from another company’s application. Our clients have been pleasantly surprised that this alternative registration approach will not add as much cost or time as they feared. It is important to remember that although the changes in the APVMA’s definition of CCI may have increased the cost of registration, by increasing the barrier to entry, the value of product registrations has increased too.
Technical Grade Active Constituents (TGACs)
Additional changes by the APVMA have added value to TGAC registrations. The address of the approved factory will no longer be listed on the APVMA’s website. In the past anyone could find details of an approved factory on the website and could approach them directly to supply the technical material. This unfairly cut out the TGAC holder from the business opportunity they had paid to create. Now that the factory disclosure is not published the intrinsic value of TGACs has increased. We have already heard of new tactics being used to keep factory information secret. For example, the registration of a TGAC requires the submission of data from five production batches. Some factories that have been asked to supply these batches by the company applying for a TGAC, have approached other companies and told them that they will be an approved source. To counter this companies are asking for samples from a number of factories but submitted the data from only one. We have heard of other tactics too. Under these new rules of non-disclosure, companies submitting product registration applications without the support of a TGAC registration may well find it harder.
One industry concern with TGAC applications was the fear that the new CCI definition would be enforced when the APVMA compared impurities in the proposed source with those of the pioneer product. Had this been the case then new applicants may have been required to supply toxicological and other data on each impurity in their sample. However, the APVMA has apparently chosen not to use the impurity data in this way.
Home Garden and DIY
Other recent changes by the APVMA have improved the confidence of those of our clients who are developing new products for the home garden and DIY market segment. The APVMA removed the need for efficacy data where a proposed product has the same active ingredient (a.i.) at equivalent concentrationand formulation type as an existing registered product. These changes have made it much easier to register improved products in this segment.
Eureka! has noticed that clients selling into the organic, home garden and DIY areas often forget that their ideas might involve an a.i. that is on, or suitable to, the “active constituents not requiring evaluation” list. It is rare to see new actives added to this list. However, the APVMA’s latest gazette proposes to add ‘clove oil’ to this list. If you have found a “soft” chemical that you would like to develop a product from you should be talking to us about how best to turn it into a product.
Lastly, a short word of thanks and commendation, to the 10 or so registration consultants we have worked with over the last six months to ensure that our collective clients can register their new products. The Australian agrochemical industry is blessed to be supported by so many good consultants!
If you have products requiring registration or product ideas that are stalled due to confusion about the new APVMA requirements, please contact Anthony Flynn
Written By: Anthony Flynn
© 2015 Eureka! AgResearch Pty Ltd