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Gazette APVMA 9, 6 September 2005 page 29
NOTICEData Protection Requirements
Chemistry Data and Data Lists
From 1 September 2005, the APVMA intends to not require details of any chemistry data provided to the APVMA to be listed in the ‘data list’ as per the ‘data protection application requirements’.
The Agvet Code limits the APVMA from using information provided in one application to be satisfied to grant another application, apart from where certain exceptions apply. The APVMA recognises this data by assigning protection status to it. Currently, the APVMA requires applicants complete a data list for all applications where data is provided. This allows the APVMA to record the data electronically and use a database to manage and search on protected data.
For applications which contain chemistry data this is seen as a waste of resources for both applicants and the APVMA due to:
- Chemistry data is required for most product registration applications and therefore, there will not be a need for another applicant or the APVMA to refer to the chemistry data provided with a previous application. The only exceptions are:
- for repack (category 8) applications where the APVMA already requires written support from the reference product registrant/formulator; or
- for closely similar (category 7) applications where no chemistry data is required due to the simple nature of the formulation and so would not need to reference chemistry data from another product.
- The APVMA is currently recording ‘information’, ie data, when it is presented in the form of a report. This allows the information to be easily identified in accordance with the regulations. Most chemistry data is often not provided in a separate report, but buried in the chemistry volume amongst other chemistry information. This makes it very difficult to identify and causes significant confusion with both applicants and the APVMA with respect to what should and shouldn’t be recorded and therefore ‘protected’.
Therefore, applicants are no longer required to include chemistry data (ie only data as per Volume 3, Part 2 of the APVMA’s Manual of Requirements and Guidelines (MORAG)) in data lists for any applications. Where other types of data are also included in an application to the APVMA, applicants are still required to include reference to this data in the data list.
For further details regarding data protection and associated matters, please see the Data Protection page of the APVMA website (http://www.apvma.gov.au/registration/data_protection.shtml).
For enquiries please contact:
Gavin Hall
Manager, Insecticides
Pesticides Program
Ph - 02 6272 3152
gavin.hall@apvma.gov.au