Changing a listed or an assessed listed medicine in the Australian Register of Therapeutic Goods (ARTG)

Applications to change existing listed and assessed listed medicines must be made via the listed medicine and assessed listed medicine forms in TGA Business Services (TBS) system.

Identifying all planned changes in the table

Before you make a change to your medicine, you will need to locate each planned change in the Change table so that you can:

• determine whether prior approval is required
• identify the change necessary (including consequential changes) to complete your application and determine the application type.

Ensure that you identify all changes that you intend to make, including changes that are consequential to the primary change.

Example: changing the maximum recommended daily dose (MRDD) on the ARTG entry may result in changes to the directions for use and medicine label.

Changing the MRDD when the medicine does not contain any ingredients that are restricted by the MRDD, is considered a C1 level change.

However, changing the directions is a C2 level change. Therefore, if the changing the MRDD also results in a change to the directions for use, a C2 level application will be required for both changes as L(A)C2 is higher than L(A)C1.

If you cannot find your proposed change in the change tables, contact us for assistance.

We have identified some of the common consequential changes and flagged them in the Change Tables, however please note this is not exhaustive.

Related information and guidance

• Listed and assessed listed medicines: Application and submission user guide
• Assessed listed medicines evidence guidelines
• General guidance for listed medicines
• CTD Module 1: Administrative information for assessed listed medicines

To amend their ARTG entry, sponsors must make a request under the provisions of section 9D of the Act. The following requestions can be made under section 9D:

• Subsection 9D(1) allows sponsors to request an update to an ARTG entry that is incomplete or incorrect
• Subsection 9D(2) allows sponsors to request safety-related variations to an ARTG entry. A variation is safety-related if it reduces the patient population, or has the effect of adding a warning or precaution
• Subsection 9D(3) allows sponsors to request other variations to an ARTG entry where the change does not reduce the quality, safety or efficacy of the medicine.

Most section 9D variations will be made under subsection 9D(3) of the Act.

Correction to an ARTG entry - subsection 9D(1) requests

A correction to an entry in the ARTG is generally a minor change to correct or complete information that was recorded incorrectly or omitted from the ARTG entry during the initial application to list the medicine.

Sponsors of listed and assessed listed medicines can request corrections to ARTG entries under paragraph 9D(1)(a) of the Act. Alternatively, the Secretary may make corrections to ARTG entries under paragraph 9D(1)(b) of the Act, at his or her initiative.

Examples of subsection 9D(1) corrections might include:

• correcting errors in product name
• correcting typographical errors in quantities of excipients
• correcting ingredient names.

For listed medicines, a request will only be considered if the current entry has omissions or mistakes that were made while listing the medicine. For Assessed listed medicines that are pre-market evaluated prior to their inclusion in the ARTG, some corrections could impact previous assessment(s) for listing or varying the medicine and may not be accepted as 9D(1) corrections. Contact us for assistance if you are unsure about a 9D(1) correction for an Assessed listed medicine.

When requesting a correction to the ARTG record, the change level shown in the Change Tables for that change does not need to be considered as the change code in Table F is used. For example, if an active ingredient for a listed medicine was not added to the ARTG entry at the time of listing, but was always included in the medicine and shown on the finished product specification at the time of listing, this may be approved as a subsection 9D(1) correction, despite that change being listed in the Change Tables as requiring an application for a new medicine with a new listing number.

You must submit:

• details of the correction or additional information to substantiate that a mistake was made
• relevant justification and documentary evidence that shows that the manufactured medicine has not changed. For example, a finished product specification that was signed and dated at the time of listing
• confirmation that the only changes being made to the ARTG entry are those identified in the request.

A TGA delegate of the Secretary will review the request to assess whether the request is valid and adequate justification has been provided.

The current ARTG number (AUST L or AUST L(A) number) is maintained. A processing fee is payable for subsection 9D(1) requests.

Some changes may result in a listed or assessed listed medicine being treated as a separate and distinct good from the medicine currently included in the ARTG under subsection 16(1A) of the Act.

In these circumstances, the 'new' good must be separately entered in the ARTG and sponsors must apply to the TGA under s. 23 of the Act for approval of a new listed medicine.

Retaining an existing AUST L or AUST L(A) number

Depending on the nature of the change, the provisions of the Therapeutic Goods (Groups) Order No. 1 of 2001 (‘the Groups Order’) may allow the AUST L or AUST L(A) number of the existing medicine to be retained for the new medicine.

A ‘grouping’ is appropriate when the new medicine is intended to replace the currently supplied medicine, enabling the transition of one product to another.

Once the ARTG entry is changed, the new product automatically becomes active and the supply of the old product must cease.

New AUST L or AUST L(A) number

If a new listed or assessed listed medicine is separate and distinct from the existing medicine and the provisions of the Groups Order do not apply, you will need to submit an application to list a new medicine. For these applications, application type is indicated as ‘New’ in the Listed and assessed listed medicines change tables on this page. A separate application for a new medicine will be required.

• For listed medicines, this is automatically detected by the system on validation. A new and unique AUST L number will be issued.
• For assessed listed medicines, you will need to select an application type for a new medicine (L(A)1-L(A)3 application). Following evaluation, a new and unique AUST L(A) number will be issued. For further information on the appropriate application level for a new medicine, see the Assessed listed medicine guidelines.

If you do not intend to continue to supply the old product after approval of the new medicine, you will need to Request to cancel the ARTG entry for the old product. This will not occur automatically.

A summary of fees charged by the TGA for listed medicines and assessed listed medicines is available on our website.

Application types

There are three application types for changes to listed medicines as described below.

Determining the application type for changes to listed medicines

When a change to the product record is made, the system will, upon validation, recognise the type of change made in accordance with the changes described in the Listed and assessed listed medicines change tables below.

If you are making more than one change to your medicine, the overall application type is determined by the change that attracts highest application level (ARTG Record Update being the lowest level and Grouping the highest).

Subsection 9D(1) requests

Some changes to listed medicines can be requested with a correction to an ARTG entry in a single application.

ARTG record updates and variations can be requested at the same time as a 9D(1) request.

Grouping changes cannot be submitted at the same time as a 9D(1) request (unless the Grouping level change also meets the criteria for a correction to an ARTG entry.

Finalising your application

After an application is successfully submitted and the fees are processed, a computer program automatically makes the approval for the Secretary (except subsection 9D(1) requests).

After an application for a subsection 9D(1) request is successfully submitted and the fees are processed, a delegate will review the information provided and decide to correct the ARTG entry for the medicine.

• If approved, an acknowledgement email is then sent that informs the sponsor that a decision has been made to vary the medicine as requested.
• If the decision is not to vary the entry in the ARTG as requested, the decision letter will include both a statement of the reasons for the decision and information on your rights to appeal the decision. See Guidance for requesting reconsideration of an initial decision.

Application types

Applications to change an ARTG entry for an assessed listed medicine are categorised into four levels as outlined below. Applications in lower levels require less supporting information, have lower fees and have reduced timeframes compared to applications in higher levels.

Determining the application level for changes to assessed listed medicines

Before you make a change to your medicine, you will need to locate each planned change in the change tables and determine the application level. You will need this to complete your application. Ensure you identify all changes that you intend to make, including changes that are consequential to the primary change.

If you are making more than one change to your medicine, the application level is determined by the change that attracts highest application level (Exemption Update being the lowest level and L(A)C2 the highest).

Supportive documentation for assessed listed medicines changes

L(A)C1 and L(A)C2 applications

For most L(A)C1 and L(A)C2 applications you will need to submit supporting documentation. To determine the information necessary to support the change, you will need to identify and understand the relevant requirements outlined in the Assessed listed medicines evidence guidelines.

When compiling your dossier:

• follow Parts A to D of the General dossier requirements
• compile your dossier according to the Common Technical Document (CTD) format.

Your application dossier needs to identify all proposed changes and include relevant supporting information.

Ensure that your application cover letter includes the information described in the guidance on preparing a cover letter in CTD Module 1: Administrative information for assessed listed medicines.

L(A)CN and Exemption update applications

You do not need to provide a cover letter or submit a dossier for L(A)CN or Exemption update application, unless specified in the change tables.

L(A)CN and Exemption update applications may be reviewed to ensure they are valid notifications.

Where the change results in a change to the medicine label (refer to Table E of the change tables, the label should be attached to the application. Labels may be reviewed to ensure that the change is consistent with the changes outlined in the application.

Evaluating and requesting information

Evaluation of an application to change an assessed listed medicine will follow the application and approval processes outlined in the Assessed listed medicines evidence guidelines.

The TGA may request additional information under section 31 of the Act, about a proposed variation or to clarify information provided.

Requests processed as notifications (L(A)CN and Exemption update applications) are not evaluated.

Timeframes and fees for applications to change assessed listed medicines

Most applications for changes to assessed listed medicines attract an application fee. For certain applications a separate evaluation fee is also payable – refer to current fees.

Regulations 16GG and 16GH of the Regulations provide for legislated timeframes for applications to change assessed listed medicines. There are different timeframes for each of the application levels. While the TGA is required to complete the assessment within the specified timeframes, applicants should not implement the change until they are advised of the formal outcome of an application. The timeframes for evaluation of changes to assessed listed medicines are provided below.

Within 40 working days of receiving a valid application¹ for an L(A) C1 or C2 level application, the TGA delegate of the Secretary will notify the applicant in writing, whether the application has passed preliminary assessment.

After the applicant is notified that the application has been accepted, the TGA delegate will have an additional evaluation timeframe to make a final decision on the change. The legislated evaluation timeframe:

• commences once an application is accepted for evaluation and applicable evaluation fee has been paid
• applies to working days only and excludes public holidays and weekends
• excludes the time when the evaluation clock has stopped (for example: the time taken by the applicant to provide responses to formal requests for information; or when the applicant and TGA agree to a mutual stop clock).

Finalising your application

If the decision is to change the entry in the ARTG for your assessed listed medicine, you will receive the decision letter. For changes processed as notifications (L(A)CN and Exempt update applications), this decision letter will be generated once payment has been processed.

If the decision is not to vary the entry in the ARTG, the decision letter will include both:

• a statement of the reasons for the decision
• information on your rights to appeal the decision. See Guidance for requesting reconsideration of an initial decision.

Terminology used in the Change Tables

The following terms are used to describe changes include:

• Change/Replacement: This generally applies to changes made to existing information in a product’s ARTG record. A change to an ingredient refers to a replacement of an ingredient with a different ingredient name, unless a certain characteristic of the ingredient has been identified (for example, ingredient quantity).
• Update addition: This generally applies when information is entered into a field that was previously empty. Update addition changes are generally due to system or legislative changes or where the sponsor is adding optional information. They also allow for changes to the rules, such as the addition of mandatory warning statements.
• Update deletion: Applies when there is a deletion of information from a non-mandatory field containing an unrestricted value.
• Addition: Applies when there is an addition of information to the product’s record that is restricted or the change creates a separate and distinct good. For example, addition of an ingredient or export name.
• Deletion: Removal of information from the product ARTG record that is restricted or the change creates a separate and distinct good.

The Change 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 terminology that is consistent with the listed medicines and assessed listed medicine online application system.

For further information about listed and assessed listed medicines, refer to the Australian Regulatory Guidelines for Complementary Medicines (ARCGM) and the Assessed Listed Medicines Evidence Guidelines.

Some consequential changes have been noted in the change table. These notes should not be considered an exhaustive list.

1. An application is considered ‘valid’ when it has been received by the TGA on the approved form and the relevant fees have been paid.
2. Consider consequential changes to indications. Where the product name implies a therapeutic indication, the implied indication in the name would need to be included in and consistent with existing approved indications.
3. Consider consequential changes to ingredient quantities. See the Table B, Table C and Table D.
4. Consider consequential changes to label. For example, reformatting and resizing of text on label, pack size. See label changes in Table E.
5. Consider consequential changes to directions for use and label. See the ‘Directions for use’ and label changes in Table E.
6. An ‘update addition’ is only acceptable for assessed listed medicines when the information being included on the ARTG entry is consistent with previously approved details.
7. Consider consequential changes to label. For example, addition/removal of indication to label, reformatting and resizing of text on label. See label changes in Table E.
8. Consider consequential changes to label. See label changes in Table E.
9. Consider consequential changes to label and formulation. See all tables.
10. Consider consequential changes to label and formulation. For example, change to plant preparation where there are no standardised components. See formulation changes in Table B and label changes in Table E.
11. Consider consequential changes to final preparation ratio and solvent details. See Table B.
12. There is currently a system limitation and in some circumstances this change needs to be processed manually by the TGA. When preparing an application, if it is not functioning correctly, a request should be made to nonprescriptionmedicines@health.gov.au.
13. Where the combined changes to the quantity or concentration of the ingredient in the medicine differs from the original medicine by no more than 2% w/w or w/v of the formulation, the application is permitted as a C1 level change.
14. Consider consequential changes to label and formulation. See label changes in Table E and formulation changes in Table C.
15. Where the combined changes to the quantity or concentration of the ingredient in the medicine differs from the original medicine by no more than 2% w/w or w/v of the formulation, the application is permitted as a C1 level change.
16. Where the combined changes to the quantity or concentration of the ingredient in the medicine differs from the original medicine by no more than 2% w/w or w/v of the formulation, the application is permitted as a C1 level change.
17. Where the combined changes to the quantity or concentration of the ingredient in the medicine differs from the original medicine by no more than 2% w/w or w/v of the formulation, the application is permitted as a C1 level change.
18. Where the combined changes to the quantity or concentration of the ingredient in the medicine differs from the original medicine by no more than 2% w/w or w/v of the formulation, the application is permitted as a C1 level change.
19. For information on proprietary ingredient mixtures that do not clearly specify the purpose of the mixture see Streamlining proprietary ingredient categories.
20. For information on proprietary ingredient mixtures that contain an active ingredient see Streamlining proprietary ingredient categories.
21. Where the combined changes to the quantity or concentration of the proprietary ingredient in the medicine differs from the original medicine by 2% w/w or w/v or less of the formulation, the application is permitted as a C1 level change.
22. The applicant must provide the formulation details for the proprietary ingredient that shows that the formulation has not changed since the medicine was listed.
23. Consider consequential changes to the MRDD or MSD. See the ‘Maximum daily dose’ and ‘Maximum single dose’ sections of Table A.