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Guidance on product changes in ELF3 (2008)

28 August 2008
note

Note

The Changes Tables included in this document should not be considered an exhaustive list and will be updated by the TGA from time to time.

The tables refer to changes using the same terminology that is designated in the ELF 3 system. For further information on the types of changes detailed, sponsors should make reference to the terms defined in Section 9.5 - Terminology Used to Describe the Changes of the Australian Regulatory Guidelines (ARCGM) Part II - Listed Complementary Medicines.

This document supersedes the September 2004 changes document.

Product changes

Following the inclusion of a product as a Listed medicine in the Australian Register of Therapeutic Goods (ARTG), sponsors may need to update certain product details. For example, developing marketing strategies may prompt changes to product details or manufacturer details may need to be updated. This document has been developed to provide assistance to sponsors so that they are able to determine the regulatory impact and cost that making changes may have to currently Listed medicines.

This guidance applies only to medicines Listed on the ARTG for supply in Australia. It does not apply to Registered medicines or medicines Listed in the ARTG for Export Only.

All changes required to be made to existing Listed medicines are to be undertaken via the Electronic Listing Facility Version 3 (ELF 3) system.

When a change to the product record is made, ELF 3 will, upon validation, recognise the type of change made in accordance with the changes described in the following tables. These changes have been determined by the legislative requirements of the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods Regulations 1990 (the Regulations) and Therapeutic Goods (Groups) Order No.1 of 2001 (the Groups Order). A summary of fees charged by the TGA for Listed medicines is available on the TGA website.

For more information on product changes (the Grouping Order, types of changes etc), sponsors should refer to Section 9 of Part II - Listed Complementary Medicines of the Australian Regulatory Guidelines for Complementary Medicines (ARGCM).

Types of changes

The types of changes are:

  • New
  • Group / Grouping
  • Vary / Variation
  • Correction of ARTG Record (ARTG).

Definitions for these terms are included below.

New:

The intended change creates a separate and distinct good, as defined under the Act, therefore a unique (new) AUST L number will be issued. An application fee equivalent to a new product is payable.

Group / Grouping:

The intended change is permitted under the Groups Order, therefore certain restrictions and conditions are applied to the application. A grouping application is only appropriate when the goods are intended to replace the currently supplied goods. The existing AUST L number is maintained. An application fee equivalent to a new product is payable.

Vary / Variation:

A minor change to a product's details. The current AUST L number is maintained. An application fee is payable.

Correction of ARTG Record:

Two types of change are possible:

  1. A minor change to a product's details. The change is made by the sponsor through an ELF application. No application fee is payable.
  2. Section 9D change: A change under Section 9D of the Act is made after a successful application to the Director of the Listing and Operations Section (LOS) of the Office of Complementary Medicine (OCM), who acts as the delegate of the Secretary. The change is only considered if the current listing has omissions or mistakes that were made while listing the product. The application can be in the form of a letter, fax or email to the Director of the LOS. The applicant must demonstrate how the omission or mistake was made and what measures will be taken in the future to prevent similar omissions or mistakes recurring. The current AUST L number is maintained. An application fee is payable upon approval of the Section 9D application.

Terminology used to describe changes

The terms used to describe changes are:

  • Change
  • Update addition
  • Update deletion
  • Addition
  • Deletion

Definitions for these terms are included below.

Change:

Generally applies to changes made to a product's ARTG record as a result of sponsor initiated changes, e.g. change of manufacturer or changes to indications or ingredients (changes to the manufacturer details do not attract a fee). A change to an ARTG listing may attract a fee.

Update addition:

This generally applies when information is required to be entered into a mandatory field in ELF 3 when the field was previously empty. Update addition changes are generally due to system changes (e.g. the data model changes between the new and old ARTG and updated versions of ELF). They also provide for changes to the rules, such as the addition of mandatory warning statements. An update addition to an ARTG listing usually does not attract a fee.

Update deletion:

Applies when there is a deletion of information from a non-mandatory field. An update deletion to an ARTG listing usually does not attract a fee.

Addition:

Applies when there is an addition of information to the product's record, e.g. addition of an ingredient or export name. An addition to an ARTG listing may attract a fee.

Deletion:

Removal of information from the product ARTG record. A deletion to an ARTG listing may attract a fee.

Glossary

AAN - Australian Approved Name

ABN - Australian Biological Name

Active ingredients - the therapeutically active ingredients that are responsible for a physiological action.

AFN - Australian Food Name

AHN - Australian Herbal Name

AHS - Australian Herbal Substance: An AHS name is defined by a reference pharmacopoeial monograph or a compositional guideline and the AHS is prepared using the part plant and preparation method stated in the reference. Essential oils are often in this category.

Carrier - an excipient ingredient that is usually added to an active ingredient in the final dosage form and which assists with delivery of the active ingredient.

Claims - are the possible therapeutic uses of the product e.g. the product 'may help maintain wellbeing'. Claims and indications are mistakenly used interchangeably. Compare to Indications.

Code Stock - a stock formulation that can be sold to a number of sponsors, who then sell the product under their own brand name.

Component - a therapeutically active substance in an active ingredient. The component can be standardised or non-standardised to the active ingredient. Where the component is standardised to an active ingredient there must be compliance with the reference monograph or compositional guideline.

Excipient ingredients - ingredients that are not therapeutically active and perform the functions of binding, colour, flavouring, filler etc.

HCN - Herbal Component Name

Indications - are the specific therapeutic actions of the product e.g. if one of the ingredients has a tradition of use for pain relief (as an anodyne), the indication could be 'may help reduce pain'. Claims and indications are mistakenly used interchangeably. Compare to Claims.

Maximum Recommended Daily Dose (MRD) - the total dose recommended to be taken in one day. The MRD is required if the formulation contains ingredients that are restricted by the daily dose.

Maximum Recommended Single Dose (MRS) - the MRS is required if the formulation contains ingredients that are restricted by a single dose.

Proprietary Ingredients (PI) - active pre-mixed ingredients or excipient pre-mixed ingredients that perform certain functions, such as film coating, or an empty capsule shell.

Changes tables

A. Product details change

Product Details Type of Change Fee Payable
1. Code Stock
Change to code stock container type. ARTG No
Update addition or update deletion to code stock type container closure, volume or unit or container type. ARTG No
Change to the code stock container closure, code stock container volume or code stock container volume unit. Vary Yes
2. Coded Warning
Change, update addition, addition or deletion of coded warning. ARTG No
3. Confidentiality Flags
Change to the confidentiality flags (e.g. 'Can this product be used as a code stock, Will excipient ingredients be confidential from agents') ARTG No
4. Container
Change, update addition or update deletion to container type. ARTG No
Change, update addition or update deletion to the type of container closure, volume or volume unit. ARTG No
Change to the type of container closure, volume, volume unit. Vary Yes
5. Daily Dose
Update addition or update deletion to the quantity or unit of the maximum recommended daily dose (MRD) when the formulation does not contain an ingredient restricted by MRD. ARTG No
Update addition to the MRD quantity or unit when the formulation contains an ingredient restricted by MRD. ARTG No
Change to the MRD quantity or unit when the formulation contains an ingredient restricted by MRD. Group Yes
Change to the quantity or unit of the MRD when the formulation does not contain an ingredient restricted by MRD. Vary Yes
6. Dose - Single Recommended
Change to the maximum recommended single dose (MRS) quantity or unit when the formulation contains an ingredient restricted by MRS. Group Yes
Change to the quantity or unit of MRS when the formulation does not contain an ingredient restricted by MRS. Vary Yes
Update addition or update deletion to the quantity or unit of the MRS when the formulation does not contain an ingredient restricted by MRS. ARTG No
Update addition to the MRS quantity or unit when the formulation contains an ingredient restricted by MRS. ARTG No
7. Dosage Form – including maximum and minimum weights
Update addition to the dosage form. ARTG No
Change to the dosage form. New Yes
Change or update addition to the minimum weight of divided dosage form quantity or unit when the formulation contains an ingredient restricted by concentration. ARTG No
Change, update addition or update deletion to the quantity or unit of the minimum weight of divided dosage form and the formulation does not contain an ingredient restricted by concentration. ARTG No
8. Formulation Name
Update addition of Medicine formulation name. ARTG No
Addition or deletion of Medicine formulation name. New Yes
Change to Medicine formulation name. Vary Yes
9. Indications
Change, addition or deletion to indications. Group Yes
10. Manufacturer Details
Change of manufacturer location. ARTG No
Change, addition or deletion of manufacturer name. ARTG No
Change, addition or deletion of manufacturer steps. ARTG No
Update addition of manufacturer location. ARTG No
11. Medicine kit
Change, addition or deletion of a medicine from a Medicine kit. New Yes
12. Product type and name
Change to the product type. ARTG No
Update addition to the product type. ARTG No
Change to product name. Group Yes
Change, addition or deletion to product export names. Group Yes
13. Route of Administration
Change, addition or deletion to the route of administration. Vary Yes

B. Active ingredient formulation changes

Product Details Type of Change Fee Payable
1. Animal content in a product
Change or update addition to animal part, animal preparation or animal type. ARTG No
Change or update to the country of origin for an ingredient of animal origin. ARTG No
Change or update deletion to the Pre-clearance Number for an ingredient of animal origin. ARTG No
Change to the 'Is this ingredient of human or animal origin' field when the ingredient type is an AAN. ARTG No
2. Carrier Details
Change to the carrier quantity or carrier unit when the carrier is restricted. Group Yes
Change, addition or deletion of a carrier when the ingredient type is an AHN. New Yes
Change to the quantity of a non restricted carrier. Vary Yes
3. Component Details
Update addition of a restricted component. ARTG No
Update addition to the field 'component standardised on this ingredient'. ARTG No
Update addition to the quantity or unit of a restricted component. ARTG No
Update addition to the quantity or quantity unit of a non-restricted mandatory component. ARTG No
Update addition of a mandatory unrestricted component. ARTG No
Change, addition or deletion to a standardised component of an active ingredient when the ingredient type is an AHN. ARTG No
Change to the quantity or units of a standardised component when the ingredient type is an AHN. New Yes
Change to the final preparation ratio amount or type when the ingredient type is an AHN, the component is not standardised and the equivalent preparation quantity has changed. New Yes
Change to the equivalent quantity or unit when the ingredient is AHN and the component is not standardised. New Yes
Change to the ingredient quantity or units when the ingredient type is an AHN, the component is not standardised and the equivalent preparation quantity has changed. New Yes
Change to the component when the component is restricted. ARTG No
Change to the quantity or unit of a restricted component. New Yes
Change to the final preparation ratio amount or type when the ingredient type is an AHN, the component is not standardised and the equivalent preparation quantity has not changed. New Yes
Change to the ingredient quantity or unit when the ingredient type is an AHN, the component is not standardised and the equivalent preparation quantity has not changed. New Yes
Change to the 'component standardised on this ingredient' field when the ingredient type is an AHN. Vary Yes
Change to the quantity of an unrestricted mandatory component. Vary Yes
Change to a mandatory unrestricted and non-standardised component. Vary Yes
Change, update addition or update deletion to the component quantity or component unit when the component is unrestricted, non-mandatory and non-standardised. Vary Yes
Change to the equivalent quantity or unit when the ingredient type is AHN and a component is standardised and the standardised component quantity has not changed. Vary Yes
Change to the ingredient quantity or unit when the ingredient type is AHN and a component is standardised and the standardised component quantity has not changed. Vary Yes
4. Equivalent Preparation, Equivalent Quantity or Equivalent Unit details
Update addition or update deletion to the equivalent preparation when the ingredient type is an AHN. ARTG No
Update addition to the equivalent preparation when the ingredient type is an AHN and the equivalent is restricted. ARTG No
Update addition or update deletion to the equivalent preparation, equivalent quantity or equivalent unit when the ingredient type is an AHS. ARTG No
Change to the equivalent preparation, equivalent quantity or equivalent unit when the ingredient type is an AHS. Vary Yes
5. Homoeopathic product
Addition to the potency of an active homoeopathic ingredient ARTG No
Update addition to the ingredient quantity or ingredient unit when the ingredient role is active homoeopathic. ARTG No
Addition to the diluent quantity or unit of an active homoeopathic ingredient when the diluent is not restricted. ARTG No
Update addition in the 'Label name' field of an active homoeopathic. ARTG No
Addition to the percentage of diluent of an active homoeopathic ingredient. ARTG No
Addition to the diluent quantity or diluent unit when the diluent is restricted and the ingredient role is active homoeopathic. ARTG No
Update addition or update deletion to the equivalent preparation, equivalent quantity or equivalent unit of an active homoeopathic when the ingredient type is an AHN or an AHS. ARTG No
Update addition or update deletion in the field 'Diluent Not Present' when the role is active homoeopathic. ARTG No
Change to the percentage of diluent of an active homoeopathic ingredient. Group Yes
Change to the diluent quantity or diluent unit when the diluent is restricted and the ingredient role is active homoeopathic. Group Yes
Change to the potency of an active homoeopathic ingredient. New Yes
Change to the diluent quantity or unit of an active homoeopathic ingredient when the diluent is not restricted. Vary Yes
Change in the 'Label name' field of an active homoeopathic Vary Yes
Change to the equivalent preparation, equivalent quantity or equivalent unit of an active homoeopathic when the ingredient type is AHN or AHS. Vary Yes
6. Ingredient Type – AAN, ABN, AHN, AHS
Update addition to the ingredient quantity or ingredient unit when the ingredient type is AAN, ABN, AHN or AHS. ARTG No
Change, addition or deletion of an active ingredient. New Yes
Change in the quantity or concentration of an active ingredient. New Yes
Change to the final preparation ratio type when the ingredient type is AHN. New Yes
Change to the equivalent quantity or unit when the ingredient type is AHN and the standardised component quantity has changed. New Yes
Change to the equivalent preparation when the ingredient type is AHN. New Yes
Change to the ingredient quantity or units when the ingredient type is AHN and the component is standardised and the standardised component quantity has changed. New Yes
Change to the final preparation ratio amount when the ingredient type is AHN. New Yes
7. Plant Part or Preparation of an ingredient that is an AHN
Addition to plant part or preparation when the ingredient type is an AHN. ARTG No
Change to plant part or preparation when the ingredient type is an AHN. New Yes
8. Solvent
Addition of a solvent when the ingredient type is an AHN. ARTG No
Addition of the percentage of solvent when the ingredient type is an AHN. ARTG No
Update addition to the solvent residue quantity or solvent residue unit when the solvent is restricted and the ingredient type is an AHN. ARTG No
Update addition of solvent residue when the solvent is restricted and the ingredient type is an AHN. ARTG No
Update addition or update deletion to the solvent residue quantity or solvent residue unit when the solvent is unrestricted and the ingredient type is an AHN. ARTG No
Change to the solvent residue quantity or solvent residue unit when the solvent is restricted and the ingredient type is an AHN. Group Yes
Change of a solvent when the ingredient type is an AHN. New Yes
Change to the percentage of solvent when the ingredient type is an AHN. New Yes
Change, addition or deletion of residual solvent when the solvent is not restricted and the ingredient is an AHN. Vary Yes
Change to the solvent residue quantity or solvent residue unit when the solvent is not restricted and the ingredient type is an AHN. Vary Yes
9. Step in Preparation
Addition of a step in preparation when the ingredient type is an AHN. ARTG No
Addition to the preparation step ratio or preparation step ratio type when the ingredient type is an AHN. ARTG No
Change or deletion of a step in preparation when the ingredient type is an AHN. New Yes
Change to the preparation step ratio or preparation step ratio type when the ingredient type is an AHN. Vary Yes

C. Excipient ingredients formulation changes

Product Details Type of Change Fee Payable
1. Animal content in a product
Change, addition or deletion to the Pre-clearance Number from an AAN or an ABN ingredient type of animal origin. ARTG No
Change or update addition to animal part, animal preparation or animal type. ARTG No
Change or update to the country of origin for animal part, animal preparation or animal type. ARTG No
Change to field 'Is this ingredient of human or animal origin' when the ingredient type is an AAN Vary Yes
2. Carrier Details
Change in the carrier quantity or carrier unit when the carrier is restricted and the ingredient type is an AHN. Group Yes
Change, addition or deletion of a carrier when the ingredient type is an AHN. New Yes
Change to the quantity of an unrestricted carrier. Vary Yes
3. Component Details
Update addition of a restricted component. ARTG No
Update addition of a mandatory unrestricted component. ARTG No
Update addition to the component quantity or component unit when the component is restricted. ARTG No
Change to the component quantity or component unit when the component is restricted. Group Yes
Change, addition or deletion of an unrestricted non-mandatory component. Vary Yes
Change, addition or update deletion to the quantity or unit of an unrestricted non-mandatory component. Vary Yes
Change, update addition or update deletion to the quantity or unit of an unrestricted mandatory component. Vary Yes
4. Equivalent preparation, equivalent quantity or equivalent unit
Change to the equivalent preparation when the ingredient type is an AHN or an AFN and the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
Change to the equivalent preparation when the ingredient type is an AHN or an AFN and the ingredient purpose is not as a colour, fragrance, flavouring, or printing ink. New Yes
Update addition or update deletion to the equivalent preparation and the equivalent is not restricted and the ingredient type is an AHN or AFN. Vary Yes
Change to the equivalent quantity or equivalent unit when the equivalent is not restricted and the ingredient type is an AHN. Vary Yes
Change, addition or update deletion of equivalent quantity or equivalent unit when the equivalent is not restricted and the ingredient type is an AFN. Vary Yes
Change to the equivalent preparation, equivalent quantity or equivalent unit the ingredient type is an AHS. Vary Yes
Update addition to the equivalent preparation when the equivalent is restricted and the ingredient type is an AFN or an AHN. ARTG No
Update addition to the equivalent quantity or equivalent unit when the equivalent is restricted and the ingredient type is an AFN. ARTG No
Update addition or update deletion to the equivalent preparation, equivalent quantity or equivalent unit the ingredient type is an AHS. ARTG No
Change to the equivalent quantity or equivalent unit when the equivalent is restricted and the ingredient type is an AHN or an AFN. Group Yes
5. Step in preparation or step ratio
Addition of a step in the preparation of an AHN when the ingredient purpose is not as a colour, fragrance, flavouring, or printing ink. ARTG No
Addition of a step in the preparation of an AHN when the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. ARTG No
Addition to the preparation step ratio or preparation step ratio type when the ingredient type is an AHN. ARTG No
Change or deletion of a step in the preparation of an AHN when the ingredient purpose is not as a colour, fragrance, flavouring, or printing ink. New Yes
Change or deletion of a step in the preparation of an AHN when the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
Change to the preparation step ratio or preparation step ratio type when the ingredient type is an AHN. Vary Yes
Change or deletion of a step in the preparation of an AHN when the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
6. Plant part or Plant preparation
Addition to the plant part or plant preparation when the ingredient type is an AHN and the ingredient purpose is not as a colour fragrance, flavouring, or printing ink. ARTG No
Addition to the plant part or plant preparation when the ingredient type is an AHN and the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. ARTG No
Change to the plant preparation when the ingredient type is an AFN and the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
Change to the plant preparation when the ingredient type is an AFN and the ingredient purpose is not as a colour, flavouring, fragrance or printing ink. New Yes
Change to the plant part or plant preparation when the ingredient type is an AHN and the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
Change to the plant part or plant preparation when the ingredient type is an AHN and the ingredient purpose is not as a colour, flavouring, fragrance or printing ink. New Yes
Update addition of solvent when the ingredient type is an AHN. ARTG No
Update addition of residual solvent when the solvent is restricted and the ingredient type is an AHN. ARTG No
Update addition to the solvent percentage when the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink and the ingredient type is an AHN. ARTG No
Update addition to the solvent residue quantity or solvent residue unit when the solvent is restricted and the ingredient type is an AHN. ARTG No
Change or deletion of a solvent when the ingredient type is an AHN and the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
Change or deletion of solvent details for ingredients that are not a colour, fragrance, flavouring, or printing ink. New Yes
Change to the solvent percentage when the ingredient type is an AHN and the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
Change to the solvent residue quantity or solvent residue unit when the solvent is restricted and the ingredient type is an AHN. Group Yes
Change to the percentage of solvent when the ingredient type is an AHN and the ingredient purpose is not as a colour, fragrance, flavouring, or printing ink. New Yes
Change, addition or deletion of residual solvent when the solvent is not restricted and the ingredient is an AHN. Vary Yes
8. Ingredient Details
Change, addition or deletion of an excipient when the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
Change, addition or deletion of an excipient when the ingredient purpose is not as a colour, fragrance, flavouring, or printing ink. New Yes
Change to the ingredient quantity or ingredient unit when the ingredient is restricted. Group Yes
Update addition to the ingredient quantity or ingredient unit when the ingredient is unrestricted. ARTG No
Change, addition or update deletion to the ingredient quantity or ingredient unit when the ingredient is unrestricted. ARTG No
9. Final preparation ratio
Change to the final preparation ratio amount or type when the ingredient type is an AHN and the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
Change to the final preparation ratio amount or type when the ingredient type is an AHN and the ingredient purpose is not as a colour, fragrance, flavouring, or printing ink. New Yes
Change to the final preparation ratio amount or type when the ingredient type is an AHN or an AFN. New Yes

D. Proprietary ingredients (PI) formulation changes

Product Details Type of Change Fee Payable
Addition, deletion or change to ingredient name when the PI purpose is film coating or coating solutions. Group Yes
Change, addition or deletion to the PI name when the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
Change to PI quantity or ingredient unit when the ingredient is restricted and the PI is not an active pre-mix. Group Yes
Addition or deletion of PI name when the ingredient purpose is as a cream base, oral base, empty capsule shell, preservative pre-mix, excipient pre-mix or sweetener. New Yes
Update deletion to PI quantity or ingredient unit when the ingredient is not restricted and the PI is not an active pre-mix. ARTG No
Change, addition or deletion to the PI name when the purpose is active pre-mix. New Yes
Change, update addition or update deletion to PI quantity or ingredient unit when the ingredient is not restricted and the PI is not an active pre-mix. Vary Yes

About the Therapeutic Goods Administration (TGA)

  • The TGA is part of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices.
  • The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.
  • The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.
  • The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. The TGA investigates reports received by it to determine any necessary regulatory action.
  • To report a problem with a medicine or medical device, please see the information on the TGA website.

© Commonwealth of Australia 2008

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