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/20416
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Annual reporting of actives—frequently asked questions
Where do I report this information?
To lodge your annual actives information please log into your online services account using your APVMA user ID. Go to ‘registrations and permits’ and select annual reporting of actives from the left hand navigation list.
What period do I need to report?
You need to report amounts of actives for the year 1 July 2015 to 30 June 2016 ie financial year 2015–16.
Who can access the annual active reporting system for a business?
Anyone in your business who already has access to the APVMA online levies and fees system such as:
- primary user for the business
- nominated and authorised agents.
Can I ask the APVMA to give someone access to the online reporting system if they don’t have it?
For the 2015–16 year we are unable to offer access which is specific to the annual reporting system. The current access is linked to being a primary user and/or having access to the APVMA online levies and fees system which means that if you add somebody this year they will also be able to see all the financial information you provide to the APVMA.
Do I need to report on actives, or actives in products which a third party—such as a local importer/distributor—imports, exports or manufactures on my behalf?
No, please only report on actives or actives contained in products, that you were directly involved in importing, manufacturing or exporting. Do not report on import, export or manufacture of actives, or actives contained in products, where you were not directly involved.
If you cannot log in to report, please see ‘Who can access the annual active reporting system for a business?' above.
Can I give the list to someone else to fill out?
Yes, click on the Excel icon in the reporting list to generate a full list of your products and actives which you can then save and distribute as required for completion.
Please note: when you have collected all your data in the spreadsheet, it will need to be entered into the online reporting system for submission to the APVMA. You can generate a final spreadsheet for your records from the reporting system.
I’m an overseas holder, can I log in to report or does my nominated agent need to do this for me? Can I give my nominated agent permission to do this?
Your nominated Australian agent can log in to report if they already have access to the APVMA online levies and fees system. Otherwise you can generate an excel spreadsheet and send it, or parts of it, to them to complete.
Please note: data collected into spreadsheets will need to be entered into the online system and submitted to the APVMA.
I have more than one active approval for the same active, can I just report it once under one of the active approvals?
Yes, data about individual actives will be aggregated so we only need the total amount of each active.
I buy formulated product from an Australian source and relabel their containers but I’m not the registrant or active approval holder. What do I need to report?
If you are not the approval holder or product registrant you do not need to report anything and it will not appear on the list we generate from the database.
What do I do if there are active approvals and/or products on the list which don’t belong to me?
Please email details to APVMA enquiries and select nil return for that item.
If I import actives that I then use to manufacture products do I need to report on both the active and the active used in product?
Yes. Where you are both the product registrant and approval holder you are required to report the amount of active you imported, exported and/or manufactured this financial year as well as the amount of active used in products that were imported, exported and/or manufactured by you in the same year.
Please note that the active approvals and product registrations are listed together in alphabetical order. So you may need to search to find the active listing.
In the listing, for your active approvals, report only the amounts that are imported or exported in the form of pure active (not formulated into products). Also report how much active was manufactured.
In the listing, for your product registrations, report how much active was imported or exported in the form of formulated product. Also report how much active was used to manufacture that product in Australia.
I have a veterinary product where the active and the product were both approved at the same time and the active does not have a separate approval number. How do I report import, export and manufacture of this active if it is not on my list?
There are some veterinary actives which do not have a separate approval number where the active was approved at the same time as product registration. While the APVMA is actively working with industry to allocate a separate approval for each of these actives, some still don’t have a separate number.
For the 2016–17 reporting year the APVMA expects to have allocated separate approval numbers for all veterinary actives which will then appear on your list for reporting purposes.
To reduce confusion for the 2015–16 year, where an active does not have a separate approval number you will only see the product in your list. Please just report activities relating to the product’s import, export or manufacture and do not attempt to reconcile the active and the product as one entry.
For example, if you imported 200 kg of active X in 2015–16 and also imported 100 kg of active X in formulated product in 2015–16, please just report the 100 kg in the product itself under the ‘imported’ heading.
Or if you manufactured 100 kg of active X and used 80 kg of active in manufacturing formulated product, please just report the 80 kg you used in the product—please do not add them together.
What if the active does not appear in the listing for my veterinary product?
In some cases above, when there is no separate number for the veterinary active, it may not appear as an active ingredient in the product listing either.
In that case, just report on those actives that are listed under that product for this 2015–16 reporting year.
Won’t there be double-counting if I report active I import which I then sell to a product registrant who reports it in product they manufacture?
No, your data will be reflected in the imported active data and the product registrant will record it as active used in manufacture.
If I import actives which I then use for manufacture do I need to report the net amount—won’t I be double counting?
No, just report the active amounts against each activity ie what you imported and what you used in manufacture or exported.
The imported or manufactured amount of active are reported in the active approvals entries in your listing.
The amount of active used to make a product is then reported in the manufactured column of the product registration entries in your listing. This accounts for how much of the active was used to make that product.
I import active that is 90 per cent pure, do I report 90 per cent of the weight?
If you import 100 kg of active please just report 100 kg of active. There is no need to adjust for purity.
How is the commercial value of this information protected?
The APVMA will ensure that data passed on to the Department of Agriculture and Water Resources does not identify holders or disclose commercial information. In situations where information on an active constituent relates to five or fewer holders of active approvals and product registrations, the quantity will be aggregated into a larger group of actives. For example, if there are less than five holders for active X, or any products made from active X, the information will be aggregated into the parent compound group.