Is your ‘Approved’ source of active constituent still Approved?

Dr Sharon Gossage

Each source (manufacturing site) of an active constituent must be separately approved by the APVMA.  There are some active constituents exempted from the requirement for approval (list of exempted actives).

However, did you know that a change to the location of an approved manufacturing plant requires a new approval? Product registrants must be sure that their formulated products only contain active constituent from an approved manufacturing site for that active constituent.

For active constituent approval holders, the Notice of Approval includes:

Conditions of approval of the active constituent:

Agricultural Active Constituents must meet Quality Assurance Requirements

a. A person must not Supply the Active Constituent, or cause it to be supplied, unless the Active Constituent:

i. complies with the APVMA Standard for the Active Constituent; and

ii. was manufactured at a site of manufacture listed in the Record of Approved Active Constituents.

It is an offence in Australia, with penalties, to supply of approved active constituents in contravention of conditions of approval. The Australian approval holder or nominated agent is responsible. A change in manufacturing plant will require a new approval application with a new 5 batch analysis report from the new manufacturing plant.

For product registration holders, a condition of your product registration is as follows:

Agricultural Products must meet Active Constituents Quality Assurance Requirements

Manufacture of Active Constituent

The Registrant must not Supply the Chemical Product, or cause it to be supplied, unless the Active Constituent contained in the Chemical Product:

a. complies with the APVMA Standard for that Active Constituent; and

b. was manufactured at a site of manufacture listed in the Record of Approved Active Constituents.

It is an offence in Australia, with penalties, to supply of registered chemical products in contravention of conditions of registration. Therefore, it is an offense to supply a registered agricultural or veterinary product using an active constituent manufactured at a different location to the one in the Record.

It is your responsibility as the Australian registration holder or Nominated Agent to ensure that your records are up to date with an acceptable Certificate of Analysis (COA) for each batch of active used in your formulated product.  If the manufacturing address has changed, you need to check with your supplier that this new site is approved, as you may be using an unapproved source of active in your formulated product!