The Australian Pesticides and Veterinary Medicines Authority (APVMA) has issued an amendment to its application standards for Item 6 and Item 7 applications, which include the registration of new chemical products that are “closely similar” to existing reference products. These APVMA Item 6 and 7 Registration Requirements is intended to improve regulatory efficiency by requiring the submission of full applications that fulfil all legislative requirements. 

Historically, applicants seeking registration of a new chemical product could use the “closely similar” approach to nominate a reference product, reducing the need to provide significant (Item 7) or any (Item 6) supporting technical data. The concept was that the APVMA could depend on data already available for the specified reference product. 

However, the APVMA is now clarifying its expectations for the data that supporting such applications. The Authority has expressly stated that it is revising its understanding of “what data must be held by the nominated reference product to meet our application requirements.” This explanation is crucial for applicants who plan to depend significantly on existing data from a reference product. 

Industry stakeholders are advised to review the updated requirements carefully and ensure their submissions align with the APVMA Item 6 and 7 Registration Requirements clarified expectations to avoid delays in the assessment process.  

These APVMA Item 6 and 7 Registration Requirements changes will go into effect immediately and will apply to all Item 6 and 7 applications currently with the APVMA.