This content is current only at the time of printing. This document was printed on 21 February 2017. A current copy is located at http://apvma.gov.au/node/11186
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Online services update
We are continually improving and enhancing our online systems to meet the needs of the people who use them. We welcome your feedback.
Enhancements and new features
Certificate of export fees change
From 17 February 2017 the Department of Foreign Affairs and Trade (DFAT) fee for a certificate of export will increase from $20 to $80. There will also be $5 courier fee charged for certificate of export applications that require DFAT authentication. For more information about the increase to DFAT’s notarial service fees, visit their website.
Minor updates to Information List editor
From 17 February 2017 a new version of the Information List Editor will be available. The new version brings the data—and sub data—lists to match those available on the online services list editor. Changes include:
- adding ‘General’ to the data type list and ‘Other Information’ to the Environment Fate data sub-type list.
- removing ‘Reproduction Studies’ from the Toxicology data sub-type list and ‘Field Dissipation Plants’ from the Environment Fate data sub-type list.
Minor updates to text
From 3 February 2017, minor updates to text will come into effect in online services regarding item 13 applications, the manage account access and pre-application assistance pages. The simple text changes will improve readability, but will not impact functionality.
Full fee payment option
From 25 November 2016, the APVMA will commence rolling out a full fee payment option, available at the time of submission for application. Payment methods include credit card, Electronic Funds Transfer and BPAY.
Further improvements include automatic generation of invoices and receipts, which will be emailed to a nominated address upon payment receipt. It will be available for download from your APVMA online services user account upon payment confirmation.
The full fee payment option for all application types will be progressively implemented over the upcoming months. A list of the items where a full fee payment option is available can be found via the Online Services Portal.
Please contact the APVMA enquiries team on +61 2 6210 4701 or by email should you require further information.
Annual return of actives 2015–16 update
Update 2 November 2016: The reporting of the annual return of actives was due to conclude at the end of September 2016. The period was initially extended until 21 October 2016. We will now be accepting annual returns until 30 November 2016. No further extensions will be granted beyond 30 November 2016. If you have any questions please email chemical review or for more information see the annual return of actives webpage.
Expanded list of notifiable variations
From 29 September 2016, an expanded list of notifiable variations will be available in online services. The APVMA has added five new changes for active constituents, products and labels, to the list of notifiable variations as an outcome of the Lower Regulatory Approaches to Registration Project. For more information see the expanded list of notifiable variations.
Applications: case manager feature for notifiable variations
From 25 August 2016, notifiable variation applications will have the name of the assigned case manager displayed on the online services dashboard. If you require assistance viewing the case manager name on the online services dashboard, please contact our enquiries team on +61 2 6210 4701 or by email.
Applications: case manager feature
From 12 August 2016, applications in evaluation will have the name of the assigned case manager displayed on the online services dashboard. This will assist the applicant to directly contact the relevant case manager, if required.
This functionality is not available for notifiable variation applications.
If you require assistance in viewing the case manager name on the online services dashboard, please contact our enquiries team on +61 2 6210 4701 or by email.
Item 8 fast-track assessment
From 29 July 2016, the APVMA is trialling a new system for fast track assessment of Item 8 applications, where the application meets the following criteria:
- repack registrations (Item 8)—where the proposed product and reference product are the same in all respects (except their name, distinguishing number and the name and business address of the applicant)
- the applicant is using their own product as the reference product
- there is no protected data associated with the reference product.
This is an initiative from the lower regulatory approaches to registration project.
Update to decision tree
From 22 July 2016, the APVMA will update the decision tree for product registrations to provide an option for an applicant to indicate they will not be providing consent for the APVMA to use confidential commercial information about a reference product. This change will now also be implemented for product variations, active approvals and active variations.
Annual reporting of active constituent data
From July 2016, the APVMA will resume the collection of data on amounts of active constituents imported, manufactured and exported each financial year—commencing with the financial year 2015–16. The online reporting module to support this data collection will be available on online services from 1 July 2016.
For more information, see Annual return of actives.
Changes to support legislative updates from 1 July
From 1 July 2016, the decision tree and application form has been changed to implement the legislative amendments to the Agricultural and Veterinary Chemicals Code Regulations 1995 which come into effect on 1 July 2016.
This change will:
- provide the ability to guide a user through decision tree to an item 13A application when the request is to substitute an excipient (non-active constituents) with another excipient (non-active constituent) in the product formulation
- restrict the permission to holder and nominated agents only, if Item 13A application submitted for or with excipient substitution.
View more information on legislative changes.
Overview documentation for secure email
On 22 June 2016, the APVMA released documentation that provides an overview of the secure mail system and answers some frequently asked questions about secure mail.
From 20 June 2016, cloning functionality for applications will be available through APVMA online services for the following applications:
- items 1–10, 10A
- items 11–18
- item 27
- items 8L, 8M, 8P
- data packages.
This functionality will allow the applicants to clone any of their previously submitted applications (for above items), when submitting a new application through the decision tree via APVMA online services. Application cloning allows previously submitted applications to be cloned in full, or selected sections may be chosen for cloning as needed.
Cloning functionality for other applications including notifiable variations, item 13A, permit items 19–23, technical assessment under item 25 and eLabels are not available at this stage.
If you require assistance in using the application cloning functionality, please contact our enquiries team on +61 2 6210 4701 or firstname.lastname@example.org.
View submitted applications and payment information
On 30 May 2016, a feature was added to online services to enable applicants to view and download their submitted applications, tax invoices and receipts in Portable Document Format (.pdf), following successful online submission of applications.
If you require assistance in viewing your submitted applications, please contact our enquiries team on +61 2 6210 4701 or email@example.com.
On 6 May 2016, a defect fix was implemented to address an issue where multiple labels could be incorrectly submitted with one application. Only one label can now be submitted per application.
This will affect applications for Item 1–10, Item 10A, Item 11, Item 12, Item 13, Item 14, Item 27 and Notifiable Variations.
If you require assistance with your label submission please contact our enquiries team on +61 2 6210 4701 or firstname.lastname@example.org.
From 2 May 2016, primary users of the APVMA online services will have the ability to view, assign and remove products and the below associated functions for an employee:
- manage products (authorised or nominated agent)—this allows the employee to manage the selected product (managing a product enables variation applications to be submitted)
- new application (authorised or nominated agent)—this allows the employee to submit applications for a new product.
To view these changes, go to APVMA online services, log in and click on the ‘Registration and permits’ tab, then select ‘Manage account access’.
Pre-application assistance enhancement
From 29 April 2016, your pre-application assistance will be linked to a company, meaning you will only see ‘Applications in Progress’ for the company you have selected to represent.
You can change the list of pre-application assistance ‘Applications in Progress’ by selecting a different company from the drop down list.
To view these changes, go to the APVMA online services portal, log in and click on the ‘Registration and permits’ tab, then select ‘Manage Account Access’.
From 3 March 2016, registered users of APVMA online services who have been granted permission by the holder of a registered product can see all applications that have been submitted for the company they represent.
To view this information, go to APVMA online services login and click on the ‘Registration and permits’ tab then select ‘Manage account access’.