This content is current only at the time of printing. This document was printed on 24 March 2017. A current copy is located at http://apvma.gov.au/node/19756
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Interpreting timeframe performance
On 1 July 2014, the APVMA adopted new legislation which changed the way we calculate and interpret regulatory timeframe performance within the agency. These changes mean it is inappropriate to compare timeframe performance for 2015–16 with results prior to 1 July 2014.
Caution is also needed when comparing 2015–16 results to 2014–15 data because 2014–15 included applications from both sets of legislation. In contrast, from 1 July 2015, all applications are subject to the new requirements (regardless of when they were received by the APVMA) and timeframe performance is to be calculated and interpreted in the manner required of the changes listed below.
The main changes relevant to the reporting of timeframe performance in the APVMA are:
- Adoption of a 100 per cent target for most regulatory decisions. Previously this was 90 per cent for product registration.
- An increase in the length of the legislated assessment period (listed in Part 2—Table of fees and assessment periods of the Agricultural and Veterinary Chemicals Code Regulations 1995) to make regulatory decisions on products, actives and permits, except for non-technical applications whose assessment period remained at three months. The assessment period varies depending on the type or item number of the application.
- Timeframe performance is now determined by a perpetual clock which measures elapsed time. For example, if a request for an item 7 application is received it must be completed within three consecutive months of it commencing evaluation and an appropriate due date is set. The application is considered within timeframe if it is completed on or before the set due date (some exceptions apply, see last bullet point). Under the previous legislation, a stop-clock was used to measure timeframe performance. With this method, the APVMA could stop the clock at any time during an assessment while we waited for the return of additional information requested from the applicant. For example, an item 7 application was considered to be within timeframe if the work took three months or less to complete (calculated as clock time), regardless of the actual elapsed time.
- The creation of two conditions which allow the APVMA to vary or extend the assessment period:
- Recatergorisation from one item number to another may be made once in the life of the application under section 70(B) Agvet Code Regulations 1995.
- The APVMA may apply one extension under section 159 of the Agvet Code. An extension of 1.33 times the original assessment period (rounded) plus one month.