APVMA Nominated Agent

 

In Australia, Agricultural and Veterinary chemical products, or additives, are regulated by the APVMA (Australian Pesticide and Veterinary Medicines Authority).   The regulations extend widely to manufacturers, suppliers, wholesalers, retailers and those advertising agricultural and veterinary products.

What is the APVMA?

APVMA regulations are intended to protect the safety and health of people, animals, plants and the environment.  They also help Australia’s trade interests.

The owner of chemical products or additives is the Holder of a permit or licence issued by APVMA.  The holder’s responsibilities are broad ranging under the AgVet Code of responsibilities.   Holders may appoint an agent – called a Nominated Agent – to act on behalf of the Holder.  Nominated Agents take on all the responsibilities of a Holder.

Foreign Holders must appoint an Australian Nominated Agent in order to maintain their registration, which is a pre-condition to making sales in Australia.

RSA can act as your Nominated Agent for APVMA requirements.  

APVMA also recognise that regulatory consultants will be needed to deal with the technical complexity of the Agvet Code requirements.  They are called Authorised Agents in APVMA speak

 

What does APVMA do?

APVMA registers holders and agents of holders.  They licence holders to sell products and additives in Australia and define a range of compliance responsibilities on holders and those in the supply chain of products from manufacture to market.  Advertisers are also caught by the Agvet Code responsibilities.

APVMA rules place the onus on Holders to comply with the regulations, including payment of an annual levy based on the value of sales.   From 2020 APVMA has added an audit function to ensure the levy is corrected calculated.  

Why use RSA as your APVMA Nominated Agent?

APVMA regulations make it a requirement for a foreign licence Holder to have an Australian Nominated Agent.   

RSA is different to other APVMA Nominated Agents.   We are not primarily a technical regulatory consultant (an Authorised Agent in APVMA terminology), although we offer those services too.   We are not a distributor and have no other potential conflict of interest, though we can help you find the right distributor.  We are not based internationally.  We are Australians, living and mainly working in Sydney, Australia. 

Above all, we are business people focussed on making sure you get accurate and impartial advice to help you make the right decisions to give your product(s) and your business the best chance of succeeding. 

You will almost certainly need a regulatory consultant to help you deal with technical matters associated with APVMA.  As with medicines and industrial chemicals, regulatory consultants play an important role interpreting the regulations to find the right category that defines a product.  Semantics are important - a change of wording and claims made about a product can significantly change the regulatory burden for a Holder.

Many of our clients come to us through a regulatory consultant who has recommended us.  We work with many regulatory consultants across Australia.  If you don’t have one, we will recommend one or more consultant for you to speak to, based on your product(s) and their expertise. 

You may also need to find a distributor, or you have sales channels already organised and need importing, warehousing and despatching services.  We can help you in these areas as well.

If your best option is to establish a legal presence in Australia, we can help you all the way.  We can create a company for you, which will become the AICIS Agent.  It needs an Australian as a director.  We can provide that person.  

We’ll help you with accounting, tax and company secretarial services.  More than that, we can help with strategy, local management, business development, marketing, sales, recruitment and operations assistance.  That’s where RSA stands out from others – we have been CEO’s of businesses overseeing all these responsibilities.  We understand how to bring them all together to make it easy for you, as a foreign manufacturer, to feel comfortable that your local operations are being overseen by experienced business executives like yourselves.

If you choose us as your APVMA Nominated Agent we stay close to you and work with you to make sure you avoid regulatory issues with your product(s), packaging or marketing.   

We can also help you in many other ways to structure and grow your business effectively.

Next steps?

We want to talk to you about your product(s), your company, your international sales elsewhere in the world and your aspirations for the Australian market.  We ask you what contacts you already have in our markets – a distributor, for example.  Do you need more information about the local markets or are you ready to get going?  

And we tell you about us – who we are, our experience and our services.

So what does it cost you to use RSA as your APVMA Nominated Agent?  Our pricing is competitive.  We keep it simple, and fair.  We provide an informal cost estimate after we know which services you need, following by a formal proposal if you are happy to proceed.

We treat all information received as confidential but we will sign a NDA at any time.  To formalise arrangements we enter a contract with you setting out all the services contracted, pricing and general terms and conditions.