This content is current only at the time of printing. This document was printed on 26 June 2021. A current copy is located at http://www.plural-consulting.com/node/18686
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END product FAQs
1. Applications and registrations
Can the APVMA tell me whether my ingredient is on one of the recognised lists of excluded nutritional or digestive (END) products?
- No. This is a matter for industry—as the owner of an agvet chemical product you intend to supply to the market you need to do this yourself by referring to the lists.
Can the APVMA tell me whether the data I hold is sufficient to support my product claims?
Can I keep my END product registered even though it doesn’t need to be registered?
- No. You would need to submit an application to vary your product’s registration so it would no longer be considered an END product.
What if the self-assessment tool says I should register my product but I don’t?
- Supplying an unregistered chemical product is an offence and the APVMA will undertake enforcement actions.
If I want to cancel my registration, will the APVMA check it is an END product first?
- No. Checking if it is an END product?is the responsibility of industry.
In a supply chain, do all manufacturers/processes at each step need to hold information to substantiate the product is an END product?
- As this issue relates to an excluded product, it will be up to the stockfeed and pet food industry to work out the best approach to ensure all parties are provided the assurances they need.
Can I retain my GMP license even if I no longer produce registrable products?
- Possession of GMP license satisfies one of the four tests.
- If you manufacture products that are registrable, then you will still need to have a GMP license to continue manufacturing registrable products.
- If you are an existing manufacturer and only produce END products, you aren’t required to maintain your manufacturing license. However, if you intend to manufacture registrable products in the future, you may want to maintain your license.
- If you are a new manufacturer only producing?END products you should not apply for a GMP license. There are other industry quality and assurance (QA) systems and manufacturing requirements you can operate under.
Do END products require claims to be put on the label?
No. Claims do not need to be displayed on the label—except under limited circumstances.
The regulations require that if a claim is being put on a label, then the product owner must be able to support the claims with the relevant scientific studies or information.
Will the APVMA undertake compliance on whether END products meet the ingredients, claims, manufacturing or labelling requirements?