Answers to common questions received by the APVMA as part of the annual reporting of actives

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 for completion.

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. 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.

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 kilograms of active X in 2017–18 and also imported 100 kilograms of active X in formulated product in 2017–18, please just report the 100 kilograms in the product itself under the ‘imported’ heading.

Or if you manufactured 100 kilograms of active X and used 80 kilograms of active in manufacturing formulated product, please just report the 80 kilograms 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, only report on those actives that are listed under that product for this 2017–18 reporting year.

Won’t there be double-counting if I report on the active I import which I then sell to a product registrant who reports it in the 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 i.e. 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 kilograms of active please just report 100 kilograms of active. There is no need to adjust for purity.

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