Standard Conditions of Registration

Conditions of Product Registration related to QA of Agricultural Actives and Products

This Chemical Product has been registered on the condition that:

Analysis Results

The Registrant must not supply the chemical product or cause it to be supplied unless the registrant has in its possession prior to the supply of each batch of the chemical product, batch analysis results that show:

  1. the active constituent contained in the chemical product complied with the APVMA Standard for that active constituent
  2. if there is an APVMA Standard for a constituent in the chemical product that is not an active constituent, the constituent complied with the APVMA Standard for that constituent
  3. the batch number of the active constituent contained in the chemical product;

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Records

The registrant must, at or prior to the supply of a batch of the chemical product by the registrant or by another person on behalf of the registrant, make or have in its possession, a Record that contains the following information:

  1. the name of the Chemical Product
  2. the APVMA product number of the Chemical Product
  3. if the Chemical Product was imported into Australia by another person on behalf of, or pursuant to an arrangement with the Registrant, the name and address of that person
  4. if the Chemical Product was manufactured in Australia by another person on behalf of, or pursuant to an arrangement with the Registrant, the name and address of that person
  5. the date of importation into, or manufacture in, Australia as the case may be
  6. the Batch Number of the Chemical Product from which the Supply was made
  7. the quantity of the Chemical Product that constitutes the Batch
  8. the Batch Number, and name and address of the manufacturer of the Active Constituent contained in the Chemical Product.

The Registrant must produce, or cause to be produced, to the APVMA any Batch Analysis Results or Record within 10 working days of the request having been made by the APVMA, or other such period as determined by the APVMA.

The Registrant must keep, or cause to be kept, any Batch Analysis Results or Record for two years after any Batch Analysis Results or Record is made.

Possession of Batch Analysis Results and Records

For the purposes of these conditions, Batch Analysis Results or Records are in the possession of the Registrant if Batch Analysis Results or Records are

  1. in the possession of the Registrant; or
  2. in the possession of another person pursuant to an arrangement with the Registrant.

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Compliance with the Standard

For the purposes of these conditions, a constituent complies with the APVMA Standard if the constituent, when measured using a validated analytical method:

  1. does not contain less than the minimum purity and/or content of the constituent as set out in the APVMA Standard for the Constituent, and
  2. does not contain more than the maximum level of any impurity as set out in the APVMA Standard.

Definitions and Interpretation

In these conditions the following words have the following meanings:

“APVMA Standard” means the standard determined by the APVMA to which a constituent contained in chemical products must comply and which is published on the APVMA website.

“Batch” means a defined quantity of material produced in a single series of operations.

“Batch Number” means that a distinctive combination of numbers and/or letters that specifically identifies a batch and from which the production history can be determined.

“Batch Analysis Results” means the results of analysis from each Batch of the Constituent that include:

  1. the name of the manufacturer and the manufacturing site address;
  2. the date of the analysis;
  3. the Batch Number and date of manufacture of the Batch;
  4. the analysis result(s) for the constituent purity and/or content and/or isomer ratio and/or the specified impurities as per the APVMA Standard for the constituent;
  5. full details and validation data for the analytical method(s) used for the determination of the constituent purity (linearity and precision) and/or the content and/or the isomer ration and/or the specified impurities (linearity, precision, accuracy and limit of quantitation if relevant)

Note: If analytical methods and validation data have been previously provided to the APVMA, a reference to that submission will suffice.

“Record” means a document in written or electronic form that contains the particulars set out in paragraph 3 and which is readily accessible for the purposes of Part 9 of the Agvet Codes (Enforcement).

“Supply” has the same meaning as given to it in Section 3 of the Agvet Codes and includes the doing of those things through, or pursuant to an arrangement with, another person.

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Conditions of Active Constituent Approval related to QA of Agricultural Actives and Products

This Active Constituent has been approved on the condition that:

  1. A person must not Supply the Active Constituent, or cause it to be supplied, unless the Active Constituent:
    1. complies with the APVMA Standard for that Active Constituent;
    2. was manufactured at a site of manufacture listed in the Record of Approved Active Constituents.
  2. A person must at the time of Supply of a Batch of the Active Constituent to another person also supply details of the Batch Number of the Active Constituent to the person to whom the active constituent was supplied.

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