New fast-track registration system

The Australian Pesticide and Veterinary Medicine Authority (APVMA) has developed a new fast track registration system to quickly process applications of low regulatory concern. The system aims to reduce regulatory burden by: accelerating approvals; reducing the number of detailed assessments; and increasing capacity for applications that require more detailed consideration. This system is being rolled out as a ‘pilot’ for repack (item 8) applications where the applicant is referencing their own product. Following the pilot study, it is expected that this fast track capability will be expanded over time. The pilot will be available from 29 July 2016 until 31 December 2016. After the pilot period, an implementation plan identifying the applications that will be included in the next phases of the system will be developed. Scope of the pilot The pilot includes applications that meet the following criteria: repack registrations (Item 8)—where the proposed product and reference product are the same in all respects; the applicant is using their own product as the reference product; there is no protected data associated with the reference product. Process for applications submitted through the pilot The fast-track system involves streamlining current application requirements and internal processes to reduce the time taken to assess simpler applications. If all required information is provided (including correct manufacturer declarations and identical labels) the application will be progressed through the new registration process and given a processing time frame of 21 days. It is important that labels submitted are: identical in respect of the use pattern, including: host crop or animal species; application or dose rate; application method or route of administration; withholding periods, and include; label claims and use instructions (including precautionary or safety instructions). If the proposed product label is not identical to the reference product or the declarations are incorrect, fast tracking an application will not be possible and the current Item 8-time frame (3 months) will apply. How to apply If your application meets the above criteria, the decision tree will direct you to the fast-track process. The fee and application requirements will remain the same for an application submitted through this process as a current repack (item 8) application. All information must be submitted with a fast-track application. This includes the full application fee, proposed label and relevant declarations from manufacturers and applicants. The 28-day period to supply supporting documentation does not apply to fast-track applications.

APVMA, 29 July 2016 ;http://www.apvma.gov.au ;