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Gazette APVMA 9, 5 September 2006 Page 22
Back to Gazette APVMA 9
Data Protection Requirements
Chemistry Data and Data Lists
In September 2005 the APVMA published a notice in the Gazette to inform applicants that from 1 September 2005, the APVMA would not require details of any chemistry data to be listed in the ‘data list’ which applicants must provide to the APVMA with an application.
The purpose of this current notice is to advise applicants that from 1 October 2006, applicants must include details of any chemistry data in the ‘data list’ which applicants provide to the APVMA with an application.
Background
The omission of chemistry data from data lists was trialed as a means of gaining efficiencies in the administration of the data protection provisions of the Agvet Codes. Ordinarily the use of chemistry data is limited to the product for which it was submitted, because of its specificity to individual formulations. The APVMA envisaged that no situation would arise where another applicant, or the APVMA would rely on chemistry data provided with a previous application to support an application for registration of a subsequent product.
Experience since 1 September 2005 has shown that situations can arise where there is potential for certain chemistry data submitted with one application to be referred to (relied on) in the assessment of another application. In addition, the APVMA has received strong representations from sectors of the chemical industry that the details of chemistry data should be included in application summaries (for transparency) and subsequently listed as protected data against individual products (where relied on) to reflect the value and intellectual property of the information.
The APVMA has reviewed the situation with regard to its administration of the data protection and transparency provisions of the Agvet Codes and has decided that in order to comply with the Agvet Codes, chemistry data submitted for each application must be recorded and subsequently identified as protected data (if relied on to grant the application) against each product. Therefore, from 1 October 2006 the APVMA will require that applicants must include details of any chemistry data in the ‘data list’ which applicants provide to the APVMA with an application.
Management of chemistry data lists
For applications received after 1 September 2005 (without chemistry data being included in a data list) that have been granted relying on chemistry data supplied with the application, the APVMA will where appropriate add a default data entry to the protected data record for the product, using the supplier of the information as the authorising party, and flagging the presence of protected chemistry data. The default entry will be:
“Chemistry data received in conjunction with an application made between 1/9/05 and 1/10/06”.
Each entry will have a unique APVMA data number. Should the authorising party for chemistry data subsequently wish to grant consent for use of that data to another party it will be necessary to quote the APVMA data number listed for the product in the ‘consent for use letter’. A template for this letter is available from the data protection page of the APVMA website.
This will also apply to those applications received between 1 September 2005 and 1 October 2006, that have not yet been granted, but for which chemistry data were supplied and relied on, unless the applicant elects to supply a data list in the required format, listing the chemistry data supplied with the application.
Should an applicant wish to exercise this option they should contact the APVMA product evaluator managing the application.
The ‘Instructions for using APVMA data list’ available from the data protection page of the APVMA website, states that information considered to be ‘data’ for the purposes of a data list includes:
- a report describing one or more tests, analyses, trials or studies
- a report summarising information necessary to meet APVMA data requirements
- a description of a method of analysis
- expert opinion on a data requirement provided by someone other than the applicant
With respect to chemistry data this will include reports of stability studies, analytical methods, validation data, batch analysis and manufacturing process (including quality control during manufacture).
This information should be presented in report form and it is the details of these reports (for example title, author, authorising party) that must be included in the data list in accordance with the ‘Instructions for using APVMA data list’.
Information such as specification sheets, certificates of analysis, MSDSs, formulation details, product specifications, container specifications will not be considered ‘data’ for the purposes of a data list and should not be included as individual items on a data list.
A guideline specific to chemistry data will be made available from the data protection page of the APVMA website.
For further details on any data protection matters, please visit the APVMA’s data protection web page at http://www.apvma.gov.au/registration/data_protection.shtml.
Comments on any data protection matter can be forwarded to:
Martin Holmes
Program Manager, Veterinary Medicines
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604
phone: (02) 6272 3471
fax: (02) 6272 3195
email: martin.holmes@apvma.gov.au