Related Information

Standard Conditions for Applications

This page provides a list of the standard conditions commonly applied to notices of active constituent approval, product registration, label approval or variation of registration. It serves as a reference document to be used in conjunction with the Advice Summaries.

On this page:

  • Conditions of Product Registration
  • Conditions of Product Label Approval for Agricultural Products
  • Conditions of Product Label Approval for Veterinary Products
  • Conditions of Active Constituent Approval
  • Agricultural Active Constituents must meet Quality Assurance Requirements

Conditions of Product Registration

Containers meet AgVet Code Regulation 18

This product can only be supplied in a container that must:

  • be impervious to, and incapable of chemical reaction with, its contents when under conditions of temperature and pressure that are likely to be encountered in normal service, and
  • have sufficient strength and impermeability to prevent leakage of its contents during handling, transport and storage under normal handling conditions, and
  • if it is intended to be opened more than once - be able to be securely and readily closed and reclosed, and
  • have sufficient excess capacity to prevent it from breaking if its contents expand during handling, transport or storage, and
  • enable all or any part of its contents to be removed or discharged in such a way that, with the exercise of no more than reasonable care, the contents cannot:
    • harm any person, or
    • have an unintended effect that is harmful to the environment

Shelf Life - Label Contains an Expiry Date

This product can only be supplied if the approved label contains an expiry date not greater than <expiry_date> after the date of manufacture of the product.

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:

  • complies with the APVMA Standard for that Active Constituent, and
  • was manufactured at a site of manufacture listed in the Record of Approved Active Constituents.

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:

  • the active constituent contained in the Chemical Product complied with the APVMA Standard for that active constituent
  • 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
  • the Batch Number of the Active Constituent contained in the Chemical Product.

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:

  • the name of the Chemical Product
  • the APVMA product number of the Chemical Product
  • 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
  • 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
  • the date of importation into, or manufacture in, Australia as the case may be
  • the Batch Number of the Chemical Product from which the Supply was made
  • the quantity of the Chemical Product that constitutes the Batch
  • 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:

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

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:

  • does not contain less than the minimum purity and/or content of the constituent as set out in the APVMA Standard for the Constituent;
  • 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 ratio and/or the specified impurities (linearity, precision, accuracy and limit of quantitation if relevant)
      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.

Product must not be Supplied Without Meeting GMP Requirements

  • The Registrant must not supply the chemical product, or cause it to be supplied, unless the chemical product has been manufactured according to the NRA/APVMA Manufacturing Principles and associated Codes of GMP, or those of a Recognised Authority deemed to be equivalent by the APVMA.
  • 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 the chemical product has been manufactured according to the NRA/APVMA Manufacturing Principles and associated Codes of GMP, or those of a Recognised Authority deemed to be equivalent by the APVMA.
  • The Registrant must produce, or cause to be produced, to the APVMA any record within 10 working days of the request having been made by the APVMA, or other such period as determined by the APVMA.
  • d) The Registrant must keep, or cause to be kept, any record for one year after the expiry date of any batch that is made.
  • e) For the purposes of these conditions, records are in the possession of the Registrant if records are:
    • in the possession of the Registrant, or
    • in the possession of another person pursuant to an arrangement with the Registrant.

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Conditions of Product Label Approval for Agricultural Products

Label must Contain a Date of Manufacture and Batch Number (Ag only)

The approved label affixed to containers must be supplied with a Date of Manufacture and Batch Number and where:

  • The Date of Manufacture and Batch Number must be either printed on the container or affixed by way of a sticker to either:
    1. the base of the main or ancillary panel of the approved label; or
    2. to the container.
  • The Date of Manufacture and Batch Number must comprise of numbers or letters, or a combination of numbers and letters and be in English.
  • Suitable prefixes may be used for the Date of Manufacture and Batch Number. These must be distinguishable from one another. For example, Date of Manufacture may include the prefix 'DOM', and Batch Number the prefix 'BN'. These details must be presented on the label or container (in accordance with (a) above) adjacent to one another and not in a position to be confused with any other numerical codes.

Label must Contain a Date of Manufacture (DOM), Batch Number and Expiry Date no Greater than 2 years after the DOM (Ag only)

The approved label affixed to containers must be supplied with a Date of Manufacture, Expiry Date and Batch Number.

  • The Date of Manufacture, Expiry Date and Batch Number must be either printed on the container or affixed by way of a sticker to either:
    • the base of the main or ancillary panel of the approved label, or
    • to the container.
  • The Date of Manufacture, Expiry Date and Batch Number must comprise of numbers or letters, or a combination of numbers and letters and be in English.
  • Suitable prefixes may be used for the Date of Manufacture, Expiry Date and Batch Number. These must be distinguishable from one another. For example, Date of Manufacture may include the prefix 'DOM', Expiry Date may include the prefix 'EXP' and Batch Number the prefix 'BN'. These details must be presented on the label or container (in accordance with (a) above) adjacent to one another and not in a position to be confused with any other numerical codes.
  • The Expiry Date must reflect a date no greater than two years from the Date of Manufacture.

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Conditions of Product Label Approval for Veterinary Products

Label must Contain an Expiry Date and Batch Number (Vet only)

The approved label affixed to containers must be supplied with an Expiry Date and Batch Number.

  • The Expiry Date and Batch Number must be either printed on the container or affixed by way of a sticker to either:
    • the base of the main or ancillary panel of the approved label, or
    • to the container
  • The Expiry Date and Batch Number must comprise of numbers or letters, or a combination of numbers and letters and be in English.
  • Suitable prefixes may be used for the Expiry Date and Batch Number. These must be distinguishable from one another. For example, Expiry Date may include the prefix 'EXP' and Batch Number the prefix 'BN'. These details must be presented on the label or container (in accordance with (a) above) adjacent to one another and not in a position to be confused with any other numerical codes.
  • The Expiry Date must reflect a date no greater than <enter period> months from the Date of Manufacture.

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Conditions of Active Constituent Approval

Agricultural Active Constituents must meet Quality Assurance Requirements

  • A person must not Supply the Active Constituent, or cause it to be supplied, unless the Active Constituent:
  • 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.
  • For the purposes of these conditions a constituent complies with the APVMA Standard if the constituent, when measured using a validated analytical method:
    • does not contain less than the minimum purity and/or content of the constituent as set out in the APVMA Standard
    • 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 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
  • “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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