Electronic Application and Registration System (EARS) - Frequently Asked Questions
Is the EARS enrolment mandatory?
Registering for EARS is not mandatory; however it is encouraged.
Who may apply?
Any Approved Person who is authorised to sign and transact on behalf of the applicant/registrant who is an entity that has the status of a person in law – either a natural person who may or may not have a registered business name, or one created by law to conduct commercial business (eg: body corporate incorporated in Australia).
Who can make transactions with EARS?
All Approved Persons wishing to securely conduct business with the APVMA using the Internet either on their own behalf or on behalf of someone else may register to make transactions via EARS. This would include Approved Persons who are as follows: Applicants/Registrants to register an Agricultural or Veterinary chemical product Registrants to vary a registered Agricultural or Veterinary chemical product Approved persons authorised to represent registrants and applicants.
What is the role of the Approved Person?
The Approved Person is an individual residing in Australia or a body corporate incorporated in Australia, who is duly authorised to sign on behalf of the Applicant/Registrant. Once the enrolment is complete, the Approved Person can conduct EARS transactions with the APVMA.
What if our company has more than one Approved Person?
It is recommended that each Approved Person register to use EARS, to obtain their own individual username and password for the company.
What if I am an Approved Person but not an employee of the Applicant/Registrant (eg: a regulatory consultant), can I use EARS?
Yes, you can use EARS through version 2. To get access to EARS you will need to complete the EARS Approved Person Access Lodgment Form for your own business/company. When your enrolment is complete, and you have received your Company Code and UserID you will need to provide this information to the company/s you are an authorised Approved Person. The Primary EARS User for those respective companies can set up your access.
The companies you are an Approved Person for, must have also registered with the APVMA to use EARS and have a Primary EARS User assigned. What is a Primary EARS User and what is their role?
A Primary EARS User must be an Approved Person who is an officer or employee of the company authorised to sign and transact on behalf of the company. Only one Primary EARS User may be assigned for each company. As a Primary EARS User, functions are available to them under the Access Management module of the EARS software version 2. The Primary EARS User, via Access Management, will be able to authorise, set up, amend and remove the access of Approved Persons who are not employees of the company but are authorised to sign and transact on behalf of the company. The Primary EARS User can also deactivate EARS access for Approved Persons employed within the company.
How do I get started?
You will need to complete the EARS Approved Person Access Lodgment Form.
Can I complete the EARS Access Lodgment form on-line?
Due to the requirement of submitting originals of the Lodgment Form enrolment may not be carried out on-line.
Where do I send my enrolment request?
Submit the completed enrolment request by mail or courier to the following address:
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604
What will I need to run the application?
What follows are suggested settings to run the application:
- Microsoft Windows 2000 or above
- 15MB HDD for installation
- CD-ROM or DVD drive for CD installation
- Internet access – Broadband (recommended)
What happens once I am registered to use EARS?
The APVMA will supply you with your username and password. The EARS software can either be downloaded from the APVMA website OR the APVMA can supply a CD with the EARS software on request.
For Approved Persons who are employees of the Applicant/Registrant you will have access to submit applications for Category 7, 8, 10, 12, 13 and 14 and view the status of submitted applications for your company. For Approved Persons who are not employees of the Applicant/Registrant (eg: regulatory consultants), your ability to submit applications and view application status through EARS will be determined by the access provided by the respective Primary EARS User of the company/s for which you are an authorised Approved Person.
How do I access EARS?
Once you have installed the EARS software on to your PC, you will need to use your Username and Password to login and access the application software.
I am a registration consultant and as the Approved Person have submitted an application for a company for which I have EARS access to view the status for a limited list of applications, but I cannot see the application status for the new application I submitted, why not?
As your EARS access has been set to view the status for a limited list of current applications submitted to the APVMA. When you submit a new application for the registration or variation of a product, this will not be in the current list of applications that you can view through EARS. However the applicant will be able to see any new applications once they are uploaded into the APVMA internal application tracking system. To view any new applications you’ve submitted on behalf of an applicant you will need to request them to amend your access to be able to view the nominated application/s via EARS and let you know when this action has been done. Once this is done, to view the application you need simply logout of EARS and login again to update the application status information.
How do I submit payment for an application submitted using EARS?
For applications submitted using EARS, the payment invoice generated from EARS provides you with three payment options, BPAY, Credit Card or Cheque;
- Paying by BPAY: Using the APVMA Biller Code and the EARS application reference number on the invoice, contact your bank, credit union or building society to make this payment directly from your saving, cheque or credit card account.
- Paying by Credit Card: Print out the payment invoice and complete the credit card details and fax the invoice to (02) 6210 4874
- Paying by Cheque: Print out the payment invoice and send your cheque with a copy of the invoice to:
Application Management and Enquiries
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604
What security measures are in place?
- Data encryption: The ability to encrypt (128 bit encryption) and decrypt electronic file attachments.
- Transmission over secure sockets layer (SSL) Internet connection.
- Electronic signature: The means to electronically sign data and documents to ensure the identity and intent of the sender of information as well as ensuring the integrity of the data that is received.
- Non-repudiation: A means to defend against a claim of denial of making a transaction in EARS. Involves the use of techniques such as timestamp, transaction logs and storing the transaction data for future reference.
What are the EARS Personalised Identification Questions (PIQ’s)?
The EARS PIQs are used to validate and authenticate the identity of an account holder. Should you forget your UserID and/or Password details the APVMA use the PIQs to confirm your identity before your login information can be reset.
Where do I call if I need assistance with various aspects of EARS?
All EARS requests should be directed to the Application Management and Enquiries unit by calling 02 6210 4701 or by email to our EARS support team.
How often is EARS data updated?
EARS is updated nightly.
How do I create a Data List in EARS?
Version 2 of the EARS client includes an additional software program called the Data List Editor. The Data List Editor can be opened from within EARS. This program allows you to create a data list for the submission data related to an application being made to the APVMA.
Can I only create Data Lists for an application submitted via EARS?
You can use the Data List Editor to create a data list for any application you are preparing to submit to the APVMA that has submission data associated with it and a data list is required. For EARS a data list can be attached with a category 10 or 14 application.
Can I attach labels to my application? What is the maximum size for attachments?
Yes, you can attach labels to an EARS application. The size limit for attachments is 10MB. This may be made up of several PDF file attachments or a single PDF file up to 10MB.
Can I attach the submission data for my category 10 or 14 application in EARS?
No, the total size limit for attachments in EARS is 10MB, and data submissions, often consisting of many studies, for Parts 2 through to 10 of an application can be very large (> 10MB). However for an application under category 10 or 14, where there is submission data that would accompany the application you can attach the data list (generated using the Data List Editor). The actual submission data must be submitted separately to the APVMA. When sending the data submission include a letter stating the reference number or a copy of the EARS application invoice to ensure it can be matched up with the EARS application.
Can I attach file types other than PDF to my EARS application submission?
For product labels and various other documents that can be attached with an application in EARS, such as a covering letter, formulator declaration, consent for access to protected data. The document must be in PDF file format this is the currently accepted file type for electronically submitted documents (eg: labels).
Attaching a data list with your EARS category 10 or 14 application, the file must be in XML format. Use the Data List Editor in EARS to create your data list as the file is saved as XML. This is the preferred file type for providing the data list details to the APVMA. As the structured format of an XML file allows easy extraction and importation of the information in to the relevant APVMA databases.
Can I submit labels or other information via EARS for an existing application that is with the APVMA?
No. EARS is for submitting new applications to the APVMA under the available categories 7, 8, 10, 12, 13 and 14. If you have additional information to provide for an application already submitted to the APVMA, it cannot be submitted via the use of EARS.
What is XML?
The Extensible Markup Language (XML) is a general-purpose specification for creating custom markup languages. It is classified as an extensible language because it allows its users to define their own elements. Its primary purpose is to facilitate the sharing of structured data across different information systems, particularly via the Internet, and it is used both to encode documents and to serialize data.
EARS uses the XML file format in this way to create a structured file of the information entered when preparing an application in EARS. Applications when submitted via EARS to the APVMA contain a copy of the XML file and any attached PDF files. When received, application information in the XML file is extracted and uploaded into the APVMA application tracking system, creating a record of the application received, replacing the need to manually enter application information.
When installing EARS version 2 what should I do with version 1.1?
It is recommended that you uninstall the version 1.1 of EARS before you install version 2, as it will not automatically override the previous version.
Can I use an application I have created again?
In EARS version 2, at the time you submit an application you will always be asked to save the file. This will allow you to save the file under a different name, so that the template application file that you want to re-use is not locked and available for use in the next application for that product.
What application categories can I submit via EARS V2?
In EARS version 2 you can submit applications for Category 7, 8, 10, 12, 13 and 14.
Can I view all applications submitted?
The EARS software provides registrants with the ability to view the status of all their applications, for those currently in progress, from preliminary assessment up to the finalisation. When an application has been finalised (eg: granted, or approved), it will no longer be visible in EARS Application Status.
The EARS registration form asks for an ACN. Is this the same as an ABN?
A company with an ACN will also have an ABN. The ABN is the same as the ACN, with two additional numbers at the front of the ACN.
Can more than one person work on the same application?
If the application has been saved on a network drive, more than one person can work on it, however only one person can work on it at a time.
Can I spell check the information I put into EARS for an application?
EARS does not have a spell or grammar checking facility available.
When selecting a product from the product list or searching in the reference product list, I get the following message: “no products were found”. What does this mean?
This message will appear when the EARS ‘localdb’ file has not downloaded completely during log in and is missing information needed by the EARS application during use. The ‘localdb’ file should be approximately 1500KB or greater in size. To correct this problem it is necessary to delete the ‘localdb’ file from where the EARS program is stored on your computer. To delete the ‘localdb’ file first close the EARS software application. Then open My Computer and go to the drive where the EARS program is stored (eg: C: drive) and go into the APVMA Electronic Applications Submissions folder. Locate the ‘localdb’ file in the folder and delete only this file from the APVMA Electronic Application Submissions folder. Once deleted open the EARS application and log in as normal, the localdb file will be downloaded in the normal process during logging in.
If the problem remains after completing the above action, contact the EARS support team for further assistance.
Can I copy text information from a Word document into the EARS fields?
Yes, you can copy and paste from Word into the various EARS fields that are open to free text entry. The only exceptions to note when copying and pasting from a word document is that all apostrophes/single quotation (‘) and double quotation (“) marks and bullets (●, and other non – letter or number bullets) and hyphen special characters (–) must be replaced or removed once the text is pasted into EARS. Also any Copyright (©), Registered (®) and Trademark (™) symbols must be removed from text pasted into EARS text entry fields. These special characters and symbols when pasted directly from a Word document are not recognised when an application is saved to XML. This will prevent a completed application from being submitted to the APVMA, as validation on the XML file will fail.
When I try to submit my application, it fails to submit successfully, the following message is shown: “An error occurred whilst processing your application. The document was not received by the APVMA. Error Detail: The document contains invalid characters”. What does this mean?
This error message indicates the XML file contains one or more of the following special characters or symbols that has been copied and pasted from a Word document into one of the EARS text entry fields:
- ‘ Apostrophe/single quotation marks
- “ Double quotation marks
- © Copyright symbol
- ® Registered symbol
- ™ Trademark symbol
- ● Bullets used for dot points (non – letter or numbered bullets)
- – Hyphen special character, inserted by Microsoft Word when typing a word/space/-/space/ word/space (eg; example – test ). Normal hyphens are accepted, when typing word/-/word, (eg; example-test)
To remove these characters you will need to go back through the EARS entry fields and remove them from wherever they occur. To help you find them, go to the directory folder the XML file is saved, double click on the file to open it in your internet browser. The window will open and say “The XML page cannot be displayed”. However under this heading it will indicate where the first invalid character was found
<Field name="purpose" id="25603">test
This example the invalid character is in the text of the Purpose of Application and Description of Use. In the EARS client, once you identify the character, remove it and click the save button. Then in your internet browser window with the XML file open, click the refresh button. When no further invalid characters are found the XML file will be displayed. If there are more invalid characters another message similar to above will be shown for the next invalid character found.
Once you have removed all the invalid characters try to submit the application again, if the submission still fails contact the EARS support team for further assistance.