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Changing an over-the-counter (OTC) medicine in the Australian Register of Therapeutic Goods

Guidance to change an ARTG registered over-the-counter (OTC) medicine.

Published
Last updated

Purpose

This guidance is for sponsors planning to change a registered over-the-counter (OTC) medicine listed on the ARTG.

It:

  • contains the OTC Changes table, which is a tool to help you obtain essential regulatory information about your change including:
    • whether prior approval is required to make the change
    • the section of the Therapeutic Goods Act 1989 (the Act) you are applying under
    • the relevant change codes; these are required to complete your application
    • the application level for the change.
  • explains how to use the OTC Changes table.

Legislation

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 Changes table so that you can:

  • determine whether prior approval is required
  • identify the change codes necessary to complete your application and determine the application level.

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

  • Check that you meet any conditions associated with the change, including those listed in the Changes Table under 'Assurance codes'.
  • If you cannot find your proposed change in the Changes table or you cannot meet the conditions for the change, see Changes not included in the Changes Table (below).

Example

If you are planning to delete an indication and a consequential change is also required to the directions for use, you must identify both the change to the indications and the change to the directions for use. There are several alternative changes to indications and directions for use described in the Changes Table, which have different conditions. You need to check which conditions apply in order to identify the correct change.

Determining whether prior approval is required

To determine if your proposed change requires prior TGA approval, check the status codes associated with each change in the Changes Table.

  • If the status code for a change is 'O', you can make the change without submitting an application for TGA approval.
    • Changes with status code 'O' cannot be selected when you complete an application in TGA Business Services as prior approval is not required.
  • If the status code is one of the following, you must obtain prior TGA approval before making the change. Follow the Process to change a registered OTC medicine to apply for approval to make the change.
    • SRR (safety related request). Application made under subsection 9D(2) of the Act.
    • SAR (self assessable request). Application made under subsection 9D(1) or 9D(3) of the Act.
    • N (notification changes). Application made under subsection 9D(2C) of the Act.
    • A (approvable changes). Application made under subsection 9D(3) or section 23 of the Act.
  • If the status code is NEW (new application required), you will need to apply for a new ARTG entry under section 23 of the Act. Follow the OTC medicine registration process.

Changes that create a separate and distinct good

Some changes may result in a medicine being treated as a separate and distinct good from the medicine currently included in the Australian Register of Therapeutic Goods (ARTG) under Section 16(1) of the Therapeutic Goods Act 1989 (the Act).

The 'new' good must be separately entered in the ARTG. However, 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 R number to be retained for the new medicine. Applications to which the 'Groups Order' applies are made under Section 23 of the Act and all require prior TGA approval (most are status code A).

If a new OTC 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 register a new OTC medicine and obtain a new AUST R number.

Determining change codes and application level

It is important that you identify all applicable change codes as you will need these to complete your application and to determine the application level. Each change that requires prior TGA approval corresponds to a particular application level based on risk (CN, C1, C2, C3 or C4).

The regulatory framework underpinning the application levels is described in the Application Categorisation Framework.

Making more than one change in a single application

If you are making more than one change to your medicine, the application level is determined by the change that attracts highest application level (CN being the lowest level and C4 the highest).

Example

You lodge an application where you change three aspects of the ARTG entry: two C1 level changes and a C3 level change. Submit the application as a C3 level application.

Changes not included in the Changes table

If the change you plan to make is not listed in the Changes table, contact OTC medicines because absence of a code does not mean you can make the change to the ARTG record without approval.

If we determine that prior approval is required and none of the change codes in the Changes table are relevant, we will send you an email that:

  • endorses the use of the appropriate 'other' change code i.e. OT1 (application level C1), OT2 (application level C2), OT3 (application level C3) or OT4 (application level C4)
  • advises you of the section of the Act that applies to the change.

In your application, you need to:

  • refer to this email in your letter of application (cover letter)
  • include our email in module 1.0.

Change table: Labelling (including package insert) and product detail changes

Labelling (including package insert) and product detail changes
Change codesLabelling (including package insert) and product detail changesStatus codesAssurance codesApplication levelApplicable section of the Act
GPN

Proprietary name (if grouping applies) where:

  1. the product name does not include an umbrella branded name or
  2. if it does contain an umbrella branded name, then the umbrella segment is not categorised as requiring a higher level of assessment
A1, 2C223
GPU

Proprietary name (if grouping applies) where:

  • the product name includes an umbrella branded name and where the umbrella segment is categorised as requiring a higher level of assessment; and/or
  • the product name has been amended to include a new 'fast acting' claim e.g. 'Farracet Rapid Tablets' on the basis of module 5 data
A1, 2C323
 Proprietary name (if grouping doesn't apply)NEW   
GINNew therapeutic indications (if grouping applies) where there is no requirement for supporting module 4 and/or module 5 data. For example, adding an indication for a 500mg paracetamol tablet from the list of representative indications in ARGOM's paracetamol guidelineA1, 3C223
GIDNew therapeutic indications (if grouping applies) where supporting module 4 and/or module 5 data or a justification for not providing the supporting data is required. For example, including an indication for a 500mg paracetamol tablet which is not included in the list of representative indications in ARGOM's paracetamol guideline.A1, 3C423
 New therapeutic indications (if grouping doesn't apply)NEW   
LIWTherapeutic indications or directions for use - change of wording without altering meaningA4, 5C29D(3)
LISTherapeutic indications - removal of sub-set of indications from labelSRR5C19D(2)
LIRTherapeutic indications - addition of registered indications to labelA5C29D(3)
GDSDirections for use - involves a reduction in the class of person for whom the goods are suitableSRR5C19D(2)
GDUDirections for use - changes to the dosage instructions (if grouping applies), other than changes described in GDS or LIW, where there is no requirement for supporting module 4 and/or module 5 data. For example, changes to the paediatric dosage recommendations for an ibuprofen oral suspension for infants and children 3 months to 12 years to be consistent with the directions in ARGOM's ibuprofen guideline.A1, 3C223
GDDDirections for use - changes to the dosage instructions (if grouping applies), where supporting module 4 and/or module 5 data or a justification for not providing the supporting data is required. For example, extending the patient population for an ibuprofen oral suspension to include use in neonates.A1, 3C423
 Directions for use (if grouping doesn't apply)NEW   
PSCRecommended storage conditions - more restrictive

N

See notifications guidance

5CN9D(2C)
PSTRecommended storage conditions - less restrictiveA5C29D(3)
LSR

Addition of more restrictive safety-related statements including:

  • reduction in the class of person for whom the goods are suitable e.g. changing a statement from "not recommended for children under 12 years" to "not recommended for children or adolescents under 18 years"
  • addition of a warning or precaution including a new RASML statement or an ARGOM warning statement (see also LRA)
SRR5C19D(2)
LRAChanges to the label to ensure compliance with RASML other than changes described in LSRSAR5C19D(3)
LNTChanges to bring a label into full compliance with TGO 92 - other than changes to the proprietary name. If changing proprietary name (and where grouping applies), also use code GPN or GPUA5C29D(3)
LSFChanges on label (signal headings, warning statements) in compliance with new SUSMP requirements, where the change in scheduling is from 'Prescription Only Medicine' (Schedule 4) to a lower OTC schedule, except where LSC appliesA5, 8C29D(3)
LSCChanges on label (signal headings, warning statements) in compliance with new SUSMP requirements, where the change in scheduling is from 'Prescription Only Medicine' (Schedule 4) to a lower OTC schedule where no such products have previously been approved as an OTC medicineA5, 8C39D(3)
LSUChanges on label (signal headings, warning statements) in compliance with new SUSMP requirements, other than LSF or LSCSRR/SAR5, 8C19D(2)/9D(3)
LLRAddition of a required representation to a label (Part 2 of Schedule 2 to the Therapeutic Goods Regulations)SRR5, 7C19D(2)
LCFColour, or type size change (no change in label copy), other than where LFT appliesSAR5C19D(3)
LFTFont or type size other than change to the type size on the main panel of the label. Does not include change in colour or label copy.

N

See notifications guidance

5CN9D(2C)
LGRIntroduction of new graphics/icons (other than as specified in change LSP & KSP)A5C29D(3)
RGRRemoval of a graphic (other than as specified in change LAB for removal of sponsor logo or RGN)SAR5C19D(3)
RGNRemoval of a graphic except where this relates to directions on how to use the product or the use of a measuring device or an applicator (see KMD and KMO)

N

See notifications guidance

5CN9D(2C)
LFOReformatting of pre-existing text (i.e. moving or duplication of blocks of text and not rewording - see LIW, LDT, LDD) and/or movement of graphics (other than specified in LGM)SAR5C19D(3)
LGMMovement of graphics provided it remains on the same panel of the label and there is no change to the size, shape or colour of the graphic and does not involve the reformatting of pre-existing text.

N

See notifications guidance

5CN9D(2C)
LLNIntroduction of a 'new' or a 'value pack' flash - see LAB for removal of a 'new' or a 'value pack' flash

N

See notifications guidance

5CN9D(2C)
LSSIntroduction of text and/or graphics pertaining to sponsorship of a campaign or organisation e.g. the Cancer Council's Pink Ribbon campaign or Surf Life Saving AustraliaA5C19D(3)
LDTDeletion or addition of text to the label (including rewording of pre-existing text) where there is no requirement for supporting module 4 and/or module 5 data (may entail the provision of quality data such as dissolution data to support a 'fast' claim), other than as specified in change LABA5C29D(3)
LDDDeletion or addition of text to the label where supporting module 4 and/or module 5 data or a justification for not providing the supporting data is required. For example, including a 'fast absorption' claim on the label on the basis of new clinical data.A5C39D(3)
KPIIntroduction of a package insert where there is no requirement for supporting module 4 and/or module 5 data. For example, including a CMI as a pack insert where the CMI is consistent with the product's approved Product Information.A5, 29C29D(3)
KPDIntroduction of a package insert where supporting module 4 and/or module 5 data or a justification for not providing the supporting data is required. For example, inclusion of a package insert with a section on absorption based on module 5 data which includes claims pertaining to 'fast' absorption.A5, 29C39D(3)
KRIRemoval of a package insertA5, 30C29D(3)
LSPChanges to sponsor details including name and/or logo (inclusion of a logo or change to an existing logo) except where LAB applies

N

See notifications guidance

5CN9D(2C)
 Changes to package insert: since the package insert is treated as part of the label, select the appropriate change code(s) from the 'Labelling (including package insert) and product detail changes' section of the Changes Table    
LAB

Minor label editorials that have no regulatory compliance impact (under the Therapeutic Goods Act 1989). The changes are limited to the following:

  • correction of misspelt words and/or deletion of a duplicated word - this does not involve rewording or the deletion of sentences or phrases;
  • removal of a 'new'/'new formulation' or a 'value pack' flash;
  • removal of details of sponsorship (in its entirety) of a campaign or organisation e.g. the Cancer Council's Pink Ribbon campaign or Surf Life Saving Australia
  • deletion of sponsor logo provided the name and address of the sponsor or supplier of the goods are included on the label
  • inclusion, removal or changes to:
    1. country of origin statement (e.g. 'Made in XX') including the statement "Made in Australia" or "Australian Made" or the Australian Made logo (gold kangaroo in a green triangle) in accordance with the requirements outlined by the Australian Made Company (refer www.australianmade.com.au - external site)
    2. sponsor address and/or contact details provided the information is consistent with the current approved product details and where the name and address of the sponsor or supplier of the goods are included on the label
    3. supplier or manufacturer's name, address and/or contact details provided the name and address of the sponsor or supplier of the goods is included on the label
    4. date of manufacture of a product
    5. website, QR code and/or bar code: applies only where the information included on the website (including any direct links from that website) or incorporated into the QR code or bar code (if either links to a website then any direct links from that website) is consistent with the information approved by the TGA for that product
    6. ABN/ACN
    7. product code number (or equivalent) or an overseas registration number
    8. recycle logo and associated text
    9. tamper evident seal - wording/graphics. See also KSL and KSX
    10. trade mark (™) or registration (®) symbols or similar or trademark statements e.g. Company XXY is a registered trademark of Company XXZ
    11. introduction, deletion or change of a graphic and/or text providing instruction on opening or closing a container
    12. anti-theft device (including directly associated wording) that does not impact on or affect the readability of other label wording.
O   
PSZAddition of a pack size for dosage forms other than liquids/semi-solids (see PLS) or metered dose aerosols (see PMZ) or as described in PSNSAR5, 6, 10C19D(3)
PSNAddition of a pack size for dosage forms other than liquids/semi-solids (see PLS) or metered dose aerosols (see PMZ) where the new pack size falls within the approved pack size range. See also PSZ.

N

See notifications guidance

5, 6, 10CN9D(2C)
PLSAddition of pack size - for liquids/semi-solids other than as described in PLNSAR5, 6, 10, 13C19D(3)
PLNAddition of pack size for liquids/semi solids where the new pack size falls within the approved pack size range. See also PLS.

N

See notifications guidance

5, 6, 10, 13CN9D(2C)
PMZAddition of pack size – for metered dose aerosolsA5C29D(3)
PSDPack size – deletion

N

See notifications guidance

5CN9D(2C)
 Dosage form (as defined in Other terminology)NEW   
PVIVisual identificationSAR5, 13, 19, 27C19D(3)
PSLShelf life - increase (other than in change PSP)A5C29D(3)
PSRShelf life - decrease

N

See notifications guidance

5CN9D(2C)
PSPShelf life - increase, where this is in accordance with a TGA approved protocol for self assessable shelf life extensions for that particular product (refer ARGOM Appendix 2, section 9.10 & 9.10.1)SAR5, 11, 20C19D(3)
PPRRequest for a stability testing protocol for self assessable shelf life extensions for a specific product (refer ARGOM Appendix 2, section 9.10)A5C29D(3)
PMISterility statusA5C29D(3)

Change table: Sponsor changes

For the transfer of a good in the ARTG from one sponsor to another contact the or see Notification of a change of sponsorship.

NB. For changes to sponsor details on the labelling see LAB and LSP; for changes to sponsor details in the PI see DAB and DAC.

Change table: Formulation changes - active ingredients

Changes to the formulation of the active ingredient, including change codes, the change that can be made using this code, the status of the code, the assurance code, the application level for the change and the section of the therapeutic goods act that applies to the change
Change codesFormulation changes - active ingredientsStatus codesAssurance codesApplication levelApplicable section of the Act
 Addition of active ingredientNEW   
 Deletion of active ingredientNEW   
 Amount of an active ingredient - see also 'Overages and ranges' in ARGOM Appendix 2, section 4.1NEW   
AOVOverage - decrease or removal

N

See guidance

5CN9D(2C)
AOAOverage - increaseA5C29D(3)
GPAReplacement of a proprietary ingredient which contains an active substance with another proprietary ingredient where the only difference between the two proprietary ingredients (other than name) is to the amount of an excipient(s) ingredient (if grouping applies)A1, 5C223
 Replacement of a proprietary ingredient which contains an active ingredient with another proprietary ingredient, other than as above in change GPANEW   

Change table: Formulation changes - excipient ingredients

Changes to the formulation of excipient ingredients, including change codes, the change that can be made using this code, the status of the code, the assurance code, the application level for the change and the section of the therapeutic goods act that applies to the change
Change codesFormulation changes - excipient ingredientsStatus codesAssurance codesApplication levelApplicable section of the Act
ERT

Removal of a fragrance, flavour, printing ink and/or colouring agent(s) if the total agent(s) are present at not more than 2% w/w or w/v (if grouping applies)

Note: this change may result in consequential changes to labelling (including the PI/CMI) and/or specifications (e.g. deletion from the label of declared ingredients or change to visual identification) which should also be addressed in accordance with the 'Changes Table'.

SAR1, 5, 13C123
GPIRemoval and/or addition of a fragrance, flavour, printing ink and/or colouring agent(s) (if grouping applies), other than change ERTA1, 5, 13C223
 Removal or addition of a fragrance, flavour, printing ink or colouring agent (if grouping doesn't apply)NEW   
GPRThe replacement of one proprietary ingredient with a different proprietary ingredient where the only difference between the two proprietary ingredients (other than name) is a change to the amount of an inactive component of the proprietary ingredient and/or manufacturing process (if grouping applies) other than ERT or GPIA1, 5, 13C223
 The replacement of one proprietary ingredient with a different proprietary ingredient other than GPI or GPRNEW   
 Addition or deletion of an excipient other than those above in change GPINEW   
GEX

Amount of excipient (if grouping applies) provided the content of the excipient is not higher than previously approved for the dosage form - if unsure, contact OTC Medicines

See also 'Batch to batch variations in quantities of certain excipients' ARGOM Appendix 2, section 5.3

A1, 5, 13C223
GED

Increase in the amount of an excipient (if grouping applies) where the content of the excipient is higher than previously approved for the dosage form - if unsure, contact OTC Medicines

See also 'Batch to batch variations in quantities of certain excipients' ARGOM Appaendix 2, section 5.3

A1, 5, 13C323
 Amount of excipient (if grouping doesn't apply) - see also 'Batch to batch variations in quantities of certain excipients' ARGOM Appendix 2, section 5.3NEW   
ESTType of starch (no change to quantity)

N

See notifications guidance

5, 12CN9D(2C)

Change table: Quality control changes - finished product specifications

Changes to the quality controls for finished product specifications, including change codes, the change that can be made using this code, the status of the code, the assurance code, the application level for the change and the section of the therapeutic goods act that applies to the change
Change codesQuality control changes - finished product specificationsStatus codesAssurance codesApplication levelApplicable section of the Act
QFXSpecification limits or requirements - more restrictiveO   
QFESpecification limits or requirements - less restrictive (except where QFA applies); where any supporting data provided consist only of module 3 (and not module 4) data.A5, 27C29D(3)
QFFSpecification limits or requirements - less restrictive; where supporting module 4 (preclinical / toxicological) data or a justification for not providing the supporting data is required. For example, a sponsor wishes to widen the limits for a related substance from the level normally applied of NMT 1% to NMT 3.5% and justifies the widening of the specification on the basis of a dossier which includes preclinical studies and published toxicology papers.A5, 27C39D(3)
QFTAddition of an extra testO   
QFUDeletion of an existing test where any supporting data provided consist only of module 3 dataA5, 27C29D(3)
QFDDeletion of an existing test where supporting module 4 data or a justification for not providing the supporting data is required. For example, a sponsor wishes to delete a particular test for a product that would normally be required but provides supporting data in the form of preclinical studies which support the sponsor's case for removal of the test from the specifications.A5, 27C39D(3)
QFIFrequency of testing - increaseO   
QFRFrequency of testing - reductionA5, 27C29D(3)
QFAChanges to the finished product specifications (test, test methods and limits / requirements) to comply with a standard as defined in the Therapeutic Goods Act 1989 (e.g. the BP or a Therapeutic Goods Order), other than as specified in change MST. No non-pharmacopoeial test / requirement is concurrently deleted from the specification.O   
QFBAnalytical method (does not include changes to tests and limits/requirements) - which has been demonstrated to maintain or improve analytical performance (accuracy, precision and / or specificity), other than as specified in change MSTO   
QFCAnalytical method - other than as specified in change QFA, QFB or MSTA5C29D(3)
QFP

Change from one default standard (as defined in the Therapeutic Goods Act 1989) to another (e.g. BP to USP) or from a 'company' or 'in-house' specification to a pharmacopoeial specification.

  • This includes deletion of the existing pharmacopoeial tests and limits.
  • This does not involve deletion of, or a change to, any current additional non-pharmacopoeial specifications e.g. residual solvents in the finished product or friability

N

See notifications guidance

5, 27CN9D(2C)

Change table: Quality control changes - starting material specifications

Changes to the quality controls for the starting materials specifications, including change codes, the change that can be made using this code, the status of the code, the assurance code, the application level for the change and the section of the therapeutic goods act that applies to the change
Change codesQuality control changes - starting material specificationsStatus codesAssurance codesApplication levelApplicable section of the Act
QSXSpecification limits or requirements - more restrictiveO   
QSESpecification limits or requirements - less restrictive (except where QSA applies); where any supporting data provided consist only of module 3 (and not module 4) data.A5, 27C29D(3)
QSFSpecification limits or requirements - less restrictive; where supporting module 4 data or a justification for not providing the supporting data is required. For example, a sponsor wishes to widen the limits for a related substance from the level normally applied of NMT 1% to NMT 3.5% and justifies the widening of the specification on the basis of a dossier which includes preclinical studies and published toxicology papers.A5, 27C39D(3)
QSTAddition of an extra testO   
QSUDeletion of an existing test where any supporting data provided consist only of module 3 data.A5, 27C29D(3)
QSDDeletion of an existing test where supporting module 4 data or a justification for not providing the supporting data is required. For example, a sponsor wishes to delete a particular test for a substance that would normally be required but provides supporting data in the form of preclinical studies which support the sponsor's case for removal of the test from the specifications.A5, 27C39D(3)
QSAChanges to the starting material specifications (test, test methods and limits/requirements) to comply with a standard as defined in the Therapeutic Goods Act 1989 (e.g. the BP or a Therapeutic Goods Order). No non-pharmacopoeial test/requirement is concurrently deleted from the specification e.g. a specification for particle size distribution.O   
QSBAnalytical method (does not include changes to test limits/requirements) - which has been demonstrated to maintain or improve analytical performance (accuracy, precision and/or specificity)O   
QSCAnalytical method - other than as specified in change QSA or QSBA5C29D(3)
QSMManufacturer of starting material (specifications unchanged)O   
QSSSupplier of starting materialO   
QSP

Change from one 'default standard' (as defined in the Therapeutic Goods Act 1989) to another (e.g. BP to USP) or from a 'company' or 'in-house' specification to a pharmacopoeial specification.

  • This includes deletion of the existing pharmacopoeial tests and limits
  • This does not include deletion of, or a change to, any current additional non-pharmacopoeial specifications e.g. particle size distribution.

N

See notifications guidance

5CN9D(2C)

Change table: Packaging changes

Changes to the packaging for OTC medicines, including change codes, the change that can be made using this code, the status of the code, the assurance code, the application level for the change and the section of the therapeutic goods act that applies to the change
Change codesPackaging changesStatus codesAssurance codesApplication levelApplicable section of the Act
 Container type (as defined in Other terminology)NEW   
KBT

Container material - if the container is a bottle, the goods are a solid dosage form (e.g. tablet) and the change in material is of a type described below:

  1. Polystyrene to PVC, polyethylene, polypropylene or glass;
  2. PVC to polyethylene, polypropylene or glass;
  3. Polyethylene to glass or polypropylene of density ≥ 0.89;
  4. From one density of polyethylene to a higher density; or
  5. Any change between glass, polyethylene of density ≥ 0.95, and polypropylene of density ≥ 0.89.

N

See notifications guidance

5, 13, 16 & 25CN9D(2C)
KGLContainer material - clear to coloured glassO   
KBL

Container material - if the container is a blister pack, the goods are a solid dosage form (e.g. tablet) and the change in material is of a type described below:

  1. PVC to PVC/PVDC or to PVC/PCTFE;
  2. PVC/PVDC to PVC/PCTFE;

or the change to the plastic component is to a material with demonstrated lower or equivalent water permeability than the existing material (see for example USP monograph '<671> Containers Permeation').

N

See notifications guidance

5, 13 & 25CN9D(2C)
KCIContainer - increase in container wall thicknessO   
KCTContainer - decrease in container wall thickness where the decrease in thickness is not considered to increase permeability of the container (e.g. a decrease in the wall thickness of a glass bottle) and where stability testing will continue for the full term of the products' shelf life and the TGA advised immediately of any batches not meeting specification.O   
KCDContainer - decrease in container wall thickness, except where KBT, KBL or KCT applyA5C29D(3)
KOTContainer material-other than in changes KBT, KGL, KBL, KCI, KCD or KCTA5C29D(3)
KCLClosure - other than changes in KCM or MDA

N

See notifications guidance

5, 13CN9D(2C)
KCMClosure, where the closure also serves as a metering component (other than MDA)A5C29D(3)
MDAChanges in pump or pump components of meter-dose aerosol (e.g. valve material)A5C29D(3)
KSLTamper evident seal - addition (including label notice to alert consumers to presence of seal). See also LABO   
KSXTamper evident seal - removal (including removal of label notice re seal). See also LABO   
KWAInert wadding material - addition, substitution or removal where stability is not affected by the actionO   
KDADesiccant - inclusion in containerA5C29D(3)
KDXDesiccant - removal from containerA5C29D(3)
KPP

Specifications of primary pack except where the primary pack is also the container

  • Does not include any other changes to the labelling such as text, graphics, colour, font, etc.

Note: primary pack is defined in subsection 3(1) of the Act as "primary pack, in relation to therapeutic goods, means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers"

O   
KSPIntroduction of a measuring device (e.g. spoon, cylinder) or applicator (e.g. finger cot). This change can include graphical representation (and associated wording where required) of the device on the label. A copy of current & proposed label must be supplied if the label is changedSAR5, 24C19D(3)
KMORemoval of a measuring device where other means of accurately measuring the dose are readily available. This change can include the deletion of graphical representation of the device (including associated wording) on the label. Does not include changes to the directions for use or any other changes to labelling such as reformatting. A copy of current & proposed label must be supplied if the label is changed.

N

See notifications guidance

5CN9D(2C)
KMDChanges to existing measuring device (e.g. spoon, cylinder) or applicator supplied with the goods or removal of an applicator, where other means of accurately administering the dose are readily available. This change can include changes to the graphical representation (and associated wording where required) of the device on the label. It can also include the addition or deletion of graphical representation (including associated wording) of the device on the label. A copy of current & proposed label must be supplied if the label is changed.SAR5, 24C19D(3)
KPA

Introduction of a primary pack (no new text or graphics)

Note: primary pack is defined in subsection 3(1) of the Act as "primary pack, in relation to therapeutic goods, means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers"

SAR5, 14C19D(3)
KPXRemoval of a primary packSAR5, 17C19D(3)
KRPIntroduction of a refill packA5C29D(3)
KRRRemoval of refill pack

N

See notifications guidance

5CN9D(2C)

Change table: Manufacturing changes - finished product

Manufacturing changes to the finished product, including change codes, the change that can be made using this code, the status of the code, the assurance code, the application level for the change and the section of the therapeutic goods act that applies to the change
Change codesManufacturing changes - finished productStatus codesAssurance codesApplication levelApplicable section of the Act
MMAAddition of a manufacturer (includes site of manufacture), other than for sterile products where MSS or MST applies

N

See notifications guidance

5CN9D(2C)
MMDDeletion of a manufacturer (includes site of manufacture).

N

See notifications guidance

5CN9D(2C)
AMSAddition of steps of manufacture, other than for sterile products where MSS or MST applies

N

See notifications guidance

5CN9D(2C)
MSDDeletion of steps of manufacture.

N

See notifications guidance

5CN9D(2C)
MPTManufacturing process: tightening of in-process limits and/or introduction of an additional in-process controlO   
MPRManufacturing process other than for 'higher risk' OTC products (see MPH or MPD) or for sterile products (see MSS or MST). See also MPTSAR5, 13C19D(3)
MPH

Manufacturing process for the following 'higher risk' OTC products:

  • microdose products (solid oral dosage forms where the active ingredient is present in an amount of less than 2mg or 2% w/w of the dosage form)
  • products with a sustained release characteristic (not including enteric coated products)
  • metered dose inhalers
  • nasal corticosteroids

where the changes have been demonstrated, for the product, to be equivalent to or superior to the approved manufacturing process

SAR5, 13C19D(3)
MPD

Manufacturing process for the following 'higher risk' OTC products:

  • microdose products (solid oral dosage forms where the active ingredient is present in an amount of less than 2mg or 2% w/w of the dosage form)
  • products with a sustained release characteristic (not including enteric coated products)
  • metered dose inhalers
  • nasal corticosteroids

except where MPH applies.

See also 'Manufacturing process validation' in ARGOM Appendix 2, section 5.2.1

A5, 13C29D(3)
MUPGMP clearance number update only. Involves no other change to the productSAR (fee exempt)5C19D(3)
MSS

For a sterile product:

  1. Addition of a manufacturer (includes site of manufacture) involving only one or more of the following steps: release for supply, secondary packaging or testing [chemical and physical or microbial]
  2. Addition of steps of manufacture involving only one or more of the following steps: release for supply, secondary packaging or testing [chemical and physical or microbial]

N

See notifications guidance

5, 9CN9D(2C)
MST

For a sterile product:

  1. Addition of a manufacturer (includes site of manufacture) other than where MSS applies
  2. Addition of steps of manufacture other than where MSS applies
  3. Change in the manufacturing process (see also 'Manufacturing process validation' in ARGOM Appendix 2, section 5.2.1)
A5C29D(3)

Change table: Consumer Medicine Information (CMI)

Changes to Consumer Medicine Information, including change codes, the change that can be made using this code, the status of the code, the assurance code, the application level for the change and the section of the therapeutic goods act that applies to the change
Change codesConsumer Medicine Information (CMI)Status codesAssurance codesApplication levelApplicable section of the Act
CPI

Introduction of a CMI for a 'Pharmacist Only Medicine' (Schedule 3) product registered after 4 July 1995 where the CMI complies with Schedule 13 to the Therapeutic Goods Regulations and is not to be included as a package insert.

Note: Change KPI or KPD applies where the CMI is to be included as a package insert.

O   
CPO

Changes to an existing CMI, where the changes are consistent with all previously approved product details and the CMI is not to be included as a package insert.

Note: Refer to the Labelling (including package insert) and product detail changes section for guidance on changes to a CMI where the CMI is to be included as a package insert (package inserts are treated as part of the label).

O   

Change table: Product Information (PI)

Changes to Product Information, including change codes, the change that can be made using this code, the status of the code, the assurance code, the application level for the change and the section of the therapeutic goods act that applies to the change
Change codesProduct Information (PI)Status codesAssurance codesApplication levelApplicable section of the Act
DPIIntroduction of a PI for an existing product where there is no requirement for supporting module 4 and/or module 5 data. For example, where the PI is essentially the same as the PI of the originator product.A5C29D(3)
DPDIntroduction of a PI for an existing product where supporting module 4 and/or module 5 data or a justification for not providing the supporting data is required. For example, where the PI includes information on clinical trials and module 5 data are provided to substantiate the information included in the PI.A5C39D(3)
DAB

Minor editorial changes that have no regulatory compliance impact (under the Therapeutic Goods Act 1989). The changes are limited to the following:

  • correction of misspelt words and/or deletion of a duplicated word - this does not involve rewording or the deletion of sentences or phrases;
  • deletion of sponsor logo provided the name and address of the sponsor is included in the PI;
  • inclusion, removal or changes to:
    1. country of origin statement (e.g. 'Made in XX')
    2. sponsor address and/or contact details provided the information is consistent with the current approved product details and where the name and address of the sponsor of the goods is included in the PI
    3. supplier/manufacturer name, address and/or contact details
    4. ABN/ACN
    5. product code number (or equivalent) or an overseas registration number
    6. trade mark (™) or registration (®)symbols or similar or trademark statements e.g. Company XXY is a registered trademark of Company XXZ
O   
DAC

Updating the PI to reflect the currently approved product details or changes consequential to other changes made in the same application. Changes are limited to the following:

  1. storage conditions
  2. sponsor details including sponsor name and/or logo (inclusion of a logo or change of an existing logo) except where DAB applies
  3. container or pack size details
  4. visual identification
  5. dosage form
  6. route of administration
  7. formulation details
  8. poisons schedule
  9. proprietary name
  10. indications (where the wording is identical to that included on the ARTG or that proposed for the ARTG as part of the same application)

Does not include changes to the directions for use

SAR5C19D(3)
DRS

Addition of more restrictive safety-related statements including:

  • reduction in the class of person for whom the goods are suitable e.g. changing a statement from 'not recommended for children under 12 years' to 'not recommended for children or adolescents under 18 years'
  • addition of a warning or precaution including a new RASML statement or an ARGOM warning statement

(See also LSR for consequential changes to labelling)

SRR5C19D(2)
DOTChanges (including addition or deletion of text or the rewording or reformatting of existing text) where there is no requirement for supporting module 4 and/or module 5 data, other than as specified in change DAB, DAC or DRS.A5C29D(3)
DODChanges other than the addition of more restrictive safety-related statements where supporting module 4 and/or module 5 data or a justification for not providing the supporting data is required. For example, updating the section on Clinical Trials where the changes made are supported by module 5 data.A5C39D(3)
DRPRemoval of a PI where the PI is not required under section 25AA of the Act. For example, removal of a PI for an unscheduled paracetamol 500mg tablet.A5C29D(3)

Change table: Other

Other changes to OTC medicines, including change codes, the change that can be made using this code, the status of the code, the assurance code, the application level for the change and the section of the therapeutic goods act that applies to the change
Change codesOtherStatus codesAssurance codesApplication levelApplicable section of the Act
CTACorrection of ARTG record in accordance with section 9D(1) of the Therapeutic Goods Act 1989. Evidence to support the change is included with the applicationSAR5, 21C19D(1)
CAOCorrection of ARTG record in accordance with section 9D(1) of the Therapeutic Goods Act 1989. An application using this change code must include written advice from the TGA advising the use of this change code for the requested change to the productSAR (fee exempt)5, 21, 31C19D(1)
OT1'Other' changes - application level C1. An 'other' code is used only when no other code applies. An application using OT1 must include written advice from the TGA advising the use of this change code for the requested change to the productASK31C1Specified in advice from TGA
OT2'Other' changes - application level C2. An 'other' code is used only when no other code applies. An application using OT2 must include written advice from the TGA advising the use of this change code for the requested change to the productASK31C2Specified in advice from TGA
OT3'Other' changes - application level C3. An 'other' code is used only when no other code applies. An application using OT3 must include written advice from the TGA advising the use of this change code for the requested change to the productASK31C3Specified in advice from TGA
OT4'Other' changes - application level C4. An 'other' code is used only when no other code applies. An application using OT4 must include written advice from the TGA advising the use of this change code for the requested change to the productASK31C4Specified in advice from TGA
IHNUpdate of ingredient name/s on labelling/Product Information in accordance with the TGA's International Harmonisation of Ingredient Names (IHIN) project.SAR (Fee Exempt)5C19D(1)

Status codes

Status codes relating to the type of application needed to make a change to a registered OTC medicine, including the status code, whether TGA approval is needed before the change can be made and the type of application needed either an application for an new ARTG entry or to change the existing entry
CodePrior TGA approval required?Description
AYesA change made under section 9D or section 23 of the Act.
SRRYesSafety Related Request: a change made under section 9D(2) of the Act.
SARYesSelf Assessable Request: a change made under section 9D(1) or section 9D(3) of the Act.
NYesNotifications: a change made under section 9D(2C) of the Act. TGA approval is made automatically upon lodgement and payment of the application.
NEWYesNew application for registration required.
ONo

The TGA does not need to be informed of changes subject to status code 'O' - no application is submitted.

Nb. 1. Change codes for 'O' status changes are not included in the application portal.

Nb. 2. Changes with status 'O' have been included for clarity and completeness and do not imply that this information is required for evaluation of an equivalent new product.

ASKYesThis applies only where one of the 'other' change codes (OT1, OT2, OT3 or OT4) is used. Refer to the Changes not included in the Changes Table for guidance.

Assurance codes

Assurances code relating to the assurances that need to be made for the types of changes to be made to an OTC registered medicine, including the code and the assurance the sponsor needs to make regarding the change to be made
CodeDescription
1.The 'new' goods are intended to replace the existing goods in use.
2.The only difference between the 'new' goods and the existing goods is the name.
3.The only differences between the 'new' goods and the existing goods are related to the indications for use and/or the directions for use.
4.No additional indications have been introduced or directions for use altered (other than change to wording).
5.No aspects of the labelling, PI, CMI, pharmaceutical data or other product details (including manufacturing process), have been changed or are to be changed, other than changes nominated in this application and those made in conformity with the Changes Table.
6.The labelling for the new pack size is unchanged, other than to indicate the new pack size number/volume.
7.The only changes made are those which bring the label into compliance with requirements of the Labelling Order, or Schedule 2 to the Therapeutic Goods Regulations 1990.
8.The change is in compliance with a requirement introduced in the most recent version or amendment of the SUSMP.
9.The nominated manufacturer is licensed to manufacture goods of this type.
10.The container type (as defined in TGA Approved Terminology for Medicines) is unchanged and container material is unchanged.
11.A stability testing protocol has been approved for this product and a copy of the approval letter is attached.
12.
  1. Neither the existing nor the new material is a modified starch; and
  2. The changeover has been validated; and
  3. At least 6 month's stability data have been generated at the maximum recommended storage temperature on product manufactured using the new type of starch, or 3 month's data at a temperature at least 10°C higher than the maximum recommended storage temperature; and
  4. Stability testing will continue for the full term of the product's shelf life and any batches not meeting specifications will be withdrawn from the market immediately and the TGA notified immediately.
13.
  1. The changeover has been validated* and the Sponsor is satisfied that the change will not adversely affect the stability of the product; and
  2. Stability testing will continue for the full term of the product's shelf life and the TGA advised immediately of any batches not meeting specifications.

*Note: Validation data will be provided during a GMP inspection or upon request by the TGA within 3 months following the request (also see Guidelines on quality aspects of OTC applications)

14.No new text or graphics have been introduced.
15.This code is intentionally blank.
16.The new container/closure system has demonstrated equal or better moisture protection in the USP test for Containers - Permeation (water vapour transmission) to that of the existing container/closure system.
17.The information on the container label is not less than the information on the primary pack.
18.This code is intentionally blank.
19.Manufacturing method and specifications, other than visual identification, have not been changed.
20.Two production batches have been tested according to the approved stability protocol and all results fall within the acceptance criteria, as specified in the approved stability protocol.
21.The changes are in accordance with s.9D(1) of the Act.
22This code is intentionally blank.
23This code is intentionally blank.
24Where a measuring device is being introduced or changed, it includes calibrations exclusively in metric units and will allow all the doses shown on the label to be measured accurately.
25The container type (as defined in TGA Approved Terminology for Medicines) is unchanged.
26This code is intentionally blank.
27A copy of the current specification plus a copy of the new specification, with the changes highlighted, have been supplied.
28This code is intentionally blank.
29A copy of the current label of the goods together with a draft copy of the new package insert have been supplied.
30A copy of the current label and package insert of the goods have been supplied.
31A copy of the written advice from the TGA advising the use of this change code for the requested change to the product has been supplied.
Topics

Page history

Show all page updates (8)

Title changed from 'Changing an OTC medicine: using the Changes Tables' to 'Changing an over-the-counter (OTC) medicine in the Australian Register of Therapeutic Goods' as part of migration to new 'Guidance' content type:

  • Consistent ‘Purpose’ heading.
  • ‘Legislation’ section to clearly show which laws the Guidance relates to.
  • ‘Page history’ section replaces document version history.
  • New page navigation features.
  • Updated page summaries.
  • Complex images include long descriptions.
  • New ‘Save as PDF’ feature.

(v2.4) authored by the OTC Medicines Evaluation Section / Scientific Operations Management Section.

Update to change codes to include further notifications, commencing 4 December 2017.

(v2.3) authored by the OTC Medicines Evaluation Section / Scientific Operations Management Section.

Update to change codes (PSC, LLN, LSP, PSR, AOV, EST, QFP, QSP, KBT, KBL, KCL, KRR, MMA, MMD, AMS, MSD) to reflect the new notification process commencing 1 July 2017.

(v2.2) authored by the OTC Medicines Evaluation and Management & Operations Section, COMB.

Addition of two new codes (identified in table as New), amendment of an existing code (identified in table as Amended) and deletion of a redundant code (LLO).

 

(V2.1) authored by the Management & Operations Section, Complementary and OTC Medicines Branch. 

  • Add new code - IHN

(V2.0) authored by theOTC CMB and Regulatory guidance team.

  • Guidance reformatted, restructured and redrafted as web pages
  • Added new codes (identified in the tables as NEW)
  • Removed duplicated and redundant change codes and consolidated other change codes for clarity
  • Amended change codes to include examples where necessary
  • Combined the 'Label changes (including package insert)' and 'Product detail changes' sections
  • Updated the 'Assurance codes' table and updated the assurance codes within the Changes Table accordingly

(V1.0) Original publication, authored by the OTC Medicines Regulatory Guidance team.

(V1.1) authored by the OTC Medicines Regulatory Guidance team.

  • Clarified requirement for analytical validation summary forms and included hyperlink
  • Clarified requirement for applications to be in common technical document (CTD) format
  • Included reference to 'different strength or size' in the Groups Order - Summary section
  • Changed references from SUSDP to SUSMP
  • Added new change codes (previously referred to as TBD)

Title changed from 'Changing an OTC medicine: using the Changes Tables' to 'Changing an over-the-counter (OTC) medicine in the Australian Register of Therapeutic Goods' as part of migration to new 'Guidance' content type:

  • Consistent ‘Purpose’ heading.
  • ‘Legislation’ section to clearly show which laws the Guidance relates to.
  • ‘Page history’ section replaces document version history.
  • New page navigation features.
  • Updated page summaries.
  • Complex images include long descriptions.
  • New ‘Save as PDF’ feature.

(v2.4) authored by the OTC Medicines Evaluation Section / Scientific Operations Management Section.

Update to change codes to include further notifications, commencing 4 December 2017.

(v2.3) authored by the OTC Medicines Evaluation Section / Scientific Operations Management Section.

Update to change codes (PSC, LLN, LSP, PSR, AOV, EST, QFP, QSP, KBT, KBL, KCL, KRR, MMA, MMD, AMS, MSD) to reflect the new notification process commencing 1 July 2017.

(v2.2) authored by the OTC Medicines Evaluation and Management & Operations Section, COMB.

Addition of two new codes (identified in table as New), amendment of an existing code (identified in table as Amended) and deletion of a redundant code (LLO).

 

(V2.1) authored by the Management & Operations Section, Complementary and OTC Medicines Branch. 

  • Add new code - IHN

(V2.0) authored by theOTC CMB and Regulatory guidance team.

  • Guidance reformatted, restructured and redrafted as web pages
  • Added new codes (identified in the tables as NEW)
  • Removed duplicated and redundant change codes and consolidated other change codes for clarity
  • Amended change codes to include examples where necessary
  • Combined the 'Label changes (including package insert)' and 'Product detail changes' sections
  • Updated the 'Assurance codes' table and updated the assurance codes within the Changes Table accordingly

(V1.0) Original publication, authored by the OTC Medicines Regulatory Guidance team.

(V1.1) authored by the OTC Medicines Regulatory Guidance team.

  • Clarified requirement for analytical validation summary forms and included hyperlink
  • Clarified requirement for applications to be in common technical document (CTD) format
  • Included reference to 'different strength or size' in the Groups Order - Summary section
  • Changed references from SUSDP to SUSMP
  • Added new change codes (previously referred to as TBD)

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