ARGOM: Guidelines on changes to OTC medicines

V1.1, April 2013

29 November 2015

This guidance has been updated and this webpage will be archived on 1 March 2016.

Please go to Process to change a registered OTC medicine for the updated guidance which you can commence using.

Picture of the cover of this publication

This interim guideline on changes to OTC medicines is based largely on ARGOM's Changes to OTC medicines (version 1.3 published October 2012). It has been updated to accommodate the new process for the pre-market evaluation of OTC medicines in Australia.

The guideline will be updated and revised as needed throughout the staged implementation of the new process.

Version history

Version Description of change Author Effective date
V1.0 Original publication OMA - OTCME 15/04/2013
V1.1

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)

OMA - OTCME 15/04/2013

Copyright

© Commonwealth of Australia 2013
This work is copyright. You may download, display, print and reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted under the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to <tga.copyright@tga.gov.au>.

Introduction

V1.1, April 2013

This interim guideline on changes to OTC medicines is based largely on ARGOM's Changes to OTC medicines (version 1.3 published October 2012). It has been updated to accommodate the new process for the pre-market evaluation of OTC medicines in Australia. The guideline will be updated and revised as needed throughout the staged implementation of the new process.

Where the sponsor of a registered OTC medicine wishes to make a change to the product, it is a condition of registration (under Section 28 of the Therapeutic Goods Act 1989 (the 'Act')) that, with limited exceptions, the change(s) requires prior TGA approval.

The 'Changes Table' provides guidance on the types of application required when a sponsor wishes to change the details of their registered OTC medicine. With the exception of changes requiring a 'new' application, the selection of a 'change code' will be linked to an application level - C1, C2, C3, or C4. This will determine the level of the application.

Where more than one change type is being proposed within a single application, the application level is determined by the highest application level (with C1 being the lowest level and C4 the highest).

What if the proposed change is not in the Changes Table?

V1.1, April 2013

If the proposed change is not described in the Changes Table, contact the staff of the OTC Medicines Evaluation Section. The absence of the proposed change from the Changes Table does not imply that the sponsor may proceed without requesting prior approval from the TGA.

If it is determined, following consultation with the OTC Medicines Evaluation Section, that none of the specific change codes are relevant to the proposed change, then the change code 'OTH' (other) will be used. The OTC Medicines Evaluation section will provide written confirmation to the sponsor, typically in the form of an email, endorsing the use of the 'OTH' change code and advising the application level (C1-C4) appropriate for the particular change. The application level will be determined in accordance with the OTC application categorisation framework for changes to approved medicines.

In general, if the proposed change is a quality related change or a change to the labelling that doesn't require the provision of safety or efficacy data, the application level is likely to either be C1 or C2. If the proposed change relates to the labelling or other product documentation (such as the product information) and it requires supporting safety or efficacy data but is not a change involving a new indication or directions for use, then it is likely to be in C3.

Written advice from the TGA confirming use of the OTH change code must be included with the application as an attachment to the cover letter and should be explicitly referred to in the cover letter.

Does the change make the therapeutic goods 'separate and distinct'?

V1.1, April 2013

Some changes may render the changed therapeutic goods separate and distinct from the present goods. Section 16 of the Act lists those criteria which make goods separate and distinct.

Where the Therapeutic Goods (Groups) Order (the 'Groups Order') applies, the sponsor of an OTC medicine can replace the existing product in the ARTG with a new OTC medicine. An example of this is when a sponsor changes the name of an existing OTC medicine in the ARTG. For a summary of the provisions of the Therapeutic Goods (Groups) Order, refer to the Groups Order - summary.

However, if a new OTC medicine is separate and distinct from the existing medicine and the Groups Order does not apply, the sponsor will need to submit a new application for registration of the medicine.

Applications to register separate and distinct OTC medicines (regardless of whether the Groups Order applies or not) do so under the provisions of Section 23 of the Act.

What data/information do I need to include with my application?

V1.1, April 2013

Once the sponsor has identified the correct application level for their application (refer Pre-market application and evaluation process), the sponsor can then refer to the OTC dossier documents matrix and appendices 1–5 of ARGOM to ascertain the data requirements for their application. Applications which include new or changed analytical procedures and associated validation data also need to include completed OTC analytical validation summary forms.

Submitting the application

V1.1, April 2013

Applications are submitted in the common technical document (CTD) format through the electronic business services (eBS) portal. The sponsor should refer to Pre-market application and evaluation process, the OTC dossier document matrix and to appendices 1–5 of ARGOM to ascertain the applicable data requirements for the application.

Other aspects of the product (that are not being changed)

V1.1, April 2013

Generally, only the requested change(s) will be reviewed at the time of application. However, some changes naturally impact on other aspects of the product which may require further clarification. If a problem is detected which is unrelated to the requested change, it may be followed up as a separate issue, but will generally not hold up processing of the application.

Sponsors should be aware that sometimes a proposed change might involve additional consequential changes (e.g. removal of a colouring agent may also require change to visual identification). In such cases, each of the relevant changes should be specified in the application.

The same change for many products?

V1.1, April 2013

A sponsor can submit an application to make an identical change(s) to multiple OTC products. This type of application applies only when the change does not require separate assessment for individual products or when there is no change unique to one particular product within the group that requires separate assessment.

An example of an acceptable application of this type is where a sponsor requests a change to the same principal licensed manufacturer for a range of registered products. However, if the sponsor wants to make an additional change to one out of the group of products (e.g. the addition of an additional Australian manufacturing site), then that product should not be included with the multiple change application. The changes for that product should be submitted as a standalone application.

Each ARTG entry included in the application must contain current and complete details for the entire submission to pass validation in eBS. If the application fails validation, then the ARTG entries require individual updating through eBS to include the new change(s) and correct the records. Individual applications require individual payment of the relevant fees for each submission made to the TGA.

Sponsors of applications involving more than one product should submit separate, individual product-specific copies of the relevant supporting documents for each Australian Registration (AUST R) number that the change applies to, for product-specific record-keeping purposes.

Applications involving 'Groupable' changes cannot be submitted as part of an application involving more than one product; 'Groupable' changes require a separate application (see 'Groups Order - summary') for each product.

Change to an entry in the ARTG

V1.1, April 2013

Section 9D of the Act refers to how the Secretary (or Secretary's Delegate, the 'Delegate') may vary entries in the ARTG.

Applications for changes to medicines that require minimal assessment by the Delegate are denoted by the 'Status Codes' "SRR" (safety related request) or "SAR" (self assessable request) in the Changes Table. The Safety Related Requests (SRR) are approved by the Delegate under section 9D(2) of the Act; the Self Assessable Requests (SAR) are approved by the Delegate under section 9D(1) or section 9D(3) of the Act. These types of changes are included in application level C1 and only require the payment of an application fee and do not require payment of evaluation fees.

All other changes denoted by 'A' as the status code in the Changes Table made under Section 9D of the Act require significant assessment by the Delegate and therefore require payment of evaluation fees as well as application fees. The applications for some change types denoted by 'A' as the status code are made under section 23 of the Act.

All applications under section 9D or section 23 of the Act require approval before the sponsor can proceed with the change. Should the application be unsuccessful, the TGA will provide a rejection letter which contains details of procedures for review of the decision. 

Groups Order - summary

V1.1, April 2013

The 'Groups Order' specifies the circumstances in which a 'separate and distinct' therapeutic good can be 'grouped' in the same ARTG entry (i.e. under the same AUST R number). In this case, a new OTC medicine can replace the existing product in the ARTG. The Groups Order explains when this is acceptable.

Section 16 of the Act sets out the criteria which make goods 'separate and distinct'. These are:

  • a different name or
  • different indications or
  • different directions for use or
  • a different type of container or
  • a different dosage form or
  • a different formulation or composition or
  • a different strength or size (disregarding pack size).

When the Groups Order does not apply, the changed goods must have a separate ARTG entry and bear a separate AUST R number. If this is the case, the sponsor should apply for registration of the changed goods as if it were an entirely new product.

The provisions of the Groups Order (as applied to non-prescription medicines) may be summarised as follows.

Name change

Goods may be grouped when the only difference between the new goods and the existing goods is the proprietary name and when the new goods are to replace the existing goods in use.

Change in the amount of an excipient

Goods may be grouped when the formulation of the new goods is to be changed only by increasing or decreasing the amount of an excipient (but not adding or deleting an excipient) and when the new goods are to replace the existing goods in use.

Removal or addition of a fragrance, flavour, printing ink or colour

Goods may be grouped when the formulation is changed only by the addition or removal of a fragrance, flavour, printing ink or colouring agent and when the new goods are to be registered in place of the existing goods.

Revised indications and/or directions for use

Goods may be grouped when only the indications and/or directions for use are changed and the new goods are to be registered in place of the existing goods.

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Changes Table - codes

V1.1, April 2013

Sponsors must select a change code(s) from the Changes Table which describes the proposed change(s) to the medicine. More than one change code can be selected in an application. Selecting these codes will determine the assurances required and the application level (C1-C4) applicable for the selected change.

It is the responsibility of the sponsor to ensure the accurate selection of the change codes so that the assurances and application level categories pertaining to each change code are correct.

Where a description of the proposed change cannot be found in the Changes Table, contact the staff of the OTC Medicines Evaluation section (refer What if the proposed change is not in the Changes Table?).

Status codes

The status codes appear in the Changes Table to provide sponsors with simple guidance on the type of application required when changing their existing good.

Code Description
A An approvable change made under section 9D or section 23 of the Act.
SRR Safety Related Request: an approvable change made under section 9D(2) of the Act.
SAR Self Assessable Request: an approvable change made under section 9D(1) or section 9D(3) of the Act.
NEW New application for registration required.
O No prior approval required. Changes with status 'O' have been included for completeness and do not imply that this information is required for evaluation of an equivalent new product
ASK This applies only where the 'OTH' (other) change code is used. The sponsor must contact the OTC Medicines Evaluation section before submitting an application with this change code (refer What if the proposed change is not in the Changes Table?).

Documentation and assurance codes

Code Description
E Evidence to support the change where an ARTG entry is to be corrected.
L A copy of the current label of the goods plus a draft copy of the new label, with the relevant changes highlighted have been supplied.
PI A copy of the current Product Information (PI) of the goods plus a draft copy of the new PI, with the relevant changes highlighted, have been supplied.
P The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) schedule level for the new pack size(s) has been selected on the application form.
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 Office of Medicines Authorisation.
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 ARGOM Appendix 2 Guidelines on quality aspects of OTC medicines).

14. No new text or graphics have been introduced.
15.

The change of material is one of the following:

  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.
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.

The change to the plastic component is one of the following:

  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').

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.

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Changes Table

V1.1, April 2013

Label changes (including package insert)

Change codes Label changes (including package insert) Status A/D* Appln level Applicable 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
A 1, 2, L C2 23
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 A 1, 2, L C3 23
Proprietary name (if grouping doesn't apply) NEW
GIN New therapeutic indications (if grouping applies) where there is no requirement for supporting data A 1, 3, L C2 23
GID New therapeutic indications (if grouping applies) where supporting data or a justification for not providing supporting data is required A 1, 3, L C4 23
New therapeutic indications (if grouping doesn’t apply) NEW
LIW Therapeutic indications or directions for use - change of wording without altering meaning A 4, L C2 9D(3)
LIS Therapeutic indications - removal of sub-set of indications from label SRR 5, L C1 9D(2)
LIR Therapeutic indications - addition of registered indications to label A 5, L C2 9D(3)
GDU Directions for use - e.g. dosage instructions (if grouping applies) where there is no requirement for supporting data. (See also LIW) A 1, 3, L C2 23
GDD Directions for use - e.g. dosage instructions (if grouping applies) where supporting data or a justification for not providing supporting data is required. (See also LIW) A 1, 3, L C4 23
Directions for use (if grouping doesn’t apply) NEW
PSC Recommended storage conditions - more restrictive SAR 5 C1 9D(3)
PST Recommended storage conditions - less restrictive A - C2 9D(3)
LSR Addition of more restrictive safety-related statements SRR 5, L C1 9D(2)
LSF Changes 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 schedule A - C2 9D(2) / 9D(3)
LSU Changes on label (signal headings, warning statements) in compliance with new SUSMP requirements, other than LSF SRR / SAR 5, 8, L C1 9D(2) / 9D(3)
LLO Changes to bring a label into compliance with the Labelling Order - other than changes to the proprietary name, indications or directions for use SRR / SAR 5, 7, L C1 9D(2) / 9D(3)
LLR Addition of a required representation to a label (Part 2 of Schedule 2 to the Therapeutic Goods Regulations) SRR 5, 7, L C1 9D(2)
LCF Colour, font, type size only (no change in label copy) SAR 5, L C1 9D(3)
LGR Introduction of new graphics/icons (other than as specified in change SSP & KSP) A - C2 9D(3)
RGR Removal of a graphic (other than as specified in change SSP) SAR 5, L C1 9D(3)
LFO Reformatting of pre-existing text (ie. moving of blocks of text and not rewording - see LIW, LRT) SAR 5, L C1 9D(3)
LRT Rewording of pre-existing text without altering meaning (other than indications or directions for use - see LIW) A - C2 9D(3)
LDT Deletion or addition of text to the label (e.g. addition or removal of claims such as clinically proven, fast/rapid action; general claims regarding the product, its nature, mechanism of action, qualifying statements, etc.) where there is no requirement for supporting data A - C2 9D(3)
LDD Deletion or addition of text to the label (e.g. addition or removal of claims such as clinically proven, fast/rapid action; general claims regarding the product, its nature, mechanism of action, qualifying statements, etc.) where supporting data or a justification for not providing supporting data is required A - C3 9D(3)
COO Addition or deletion of a country of origin statement e.g. 'Made in xx' SAR 5, L C1 9D(3)

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Sponsor changes

Change codes Sponsor changes Status A/D* Appln level Applicable section of the Act
SSP Sponsor name/logo/sponsor address (same sponsor of goods) and/or change to manufacturer/supplier details on label SAR 5, L C1 9D(3)

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Product detail changes

Change codes Product detail changes Status A/D* Appln level Applicable section of the Act
PSZ Pack size - other than liquids/semi-solids (see PLS) or metered dose aerosols (see PMZ) (see also KBT, KGL, KBL and KOT) SAR 5, 6, 10, L, P C1 9D(3)
PLS Pack size - liquids/semi-solids SAR 5, 6, 10, 13, L, P C1 9D(3)
PMZ Pack size - metered dose aerosols A - C2 9D(3)
Dosage form (as defined in TGA Approved Terminology for Medicines) NEW
PVI Visual identification SAR 5, 13, 19 C1 9D(3)
PSL Shelf life - increase (other than in change PSP) A - C2 9D(3)
PSR Shelf life - decrease SAR 5 C1 9D(3)
PSP Shelf life - increase (in accordance with an approved stability testing protocol for that product) SAR 5, 11, 20 C1 9D(3)
PPR Approval of a stability testing protocol for a specific product A - C2 9D(3)
PSC Recommended storage conditions - more restrictive SAR 5 C1 9D(3)
PST Recommended storage conditions - less restrictive A - C2 9D(3)
PMI Sterility status/technique A - C2 9D(3)

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Formulation changes - active ingredients

Change codes Formulation changes - active ingredients Status A/D* Appln level Applicable section of the Act
Addition of active ingredient NEW
Deletion of active ingredient NEW
Amount of an active ingredient - see also 'Overages and ranges' in ARGOM Appendix 2, section 4.1 NEW
AOV Overage - decrease SAR 5 C1 9D(3)
AOA Overage - increase A - C2 9D(3)
GPA Change to amount of an excipient ingredient within a proprietary ingredient which contains an active substance (e.g. a direct-compression paracetamol mix) (if grouping applies) A 1 C2 23
Change to a proprietary ingredient which contains an active ingredient, other than as above in change GPA NEW

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Formulation changes - excipient ingredients

Change codes Formulation changes - excipient ingredients Status A/D* Appln level Applicable section of the Act
GPI Removal and/or addition of a fragrance, flavour, printing ink or colouring agent (if grouping applies), other than change ERT A 1, 13 C2 23
Removal or addition of a fragrance, flavour, printing ink or colouring agent (if grouping doesn't apply) NEW
ERT

Removal of 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 (eg. deletion from the label of declared ingredients that are no longer relevant; change to visual identification and finished product specifications) which should also be addressed in accordance with the 'Changes Table'.

SAR 5 C1 23
Addition of excipient other than those above in change GPI NEW
Deletion of excipient other than those above in change GPI NEW
GEX Amount of excipient (if grouping applies) A 1 C2 23
Amount of excipient (if grouping doesn't apply) – see also 'Batch to batch variations in quantities of certain excipients' ARGOM Appendix 2, section 5.3 NEW
EST Type of starch SAR 5, 12 C1 9D(3)
EWI Change to ingredients within a proprietary ingredient which is a flavour, fragrance, printing ink or colour (proprietary ingredient has same name) SAR 5, 13 C1 9D(3)
EWA Change to ingredients within a proprietary ingredient which is an excipient (other than above in change EWI) A - C2 9D(3)

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Quality control changes - finished product specifications

Change codes Quality control changes - finished product specification Status A/D* Appln level Applicable section of the Act
QFX Specification ranges - more restrictive O
QFE Specification ranges - less restrictive A - C2 9D(3)
QFT Addition of an extra test O -
QFU Deletion of an existing test A - C2 9D(3)
QFA Analytical method - to comply with amendments to a standard (e.g. the BP or a Therapeutic Goods Order) O
QFB Analytical method - which has been demonstrated to maintain or improve analytical performance (accuracy, precision and/or specificity) O
QFC Analytical method - other than as specified above in change QFB A - C2 9D(3)
QFS Expiry specification ranges following changes to the BP or the General standard for tablets pills and capsules or changes to the USP where a USP monograph has been approved by the TGA in relation to the product O

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Quality control changes - starting material specifications

Change codes Quality control changes - starting material specifications Status A/D* Appln level Applicable section of the Act
QSX Range - more restrictive O
QSE Range - less restrictive A - C2 9D(3)
QST Addition of an extra test O
QSU Deletion of an existing test A - C2 9D(3)
QSA Analytical method - to comply with amendments to a standard (i.e. the BP, EP, USP or a Therapeutic Goods Order) O
QSB Analytical method - which has been demonstrated to maintain or improve analytical performance (accuracy, precision and/or specificity) O
QSC Analytical method - other than as specified above in change QSB A - C2 9D(3)
QSM Manufacturer of starting material (specifications unchanged) O
QSS Supplier of starting material O

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Packaging changes

Change codes Packaging changes Status A/D* Appln level Applicable section of the Act
Container type (as defined in TGA Approved Terminology for Medicines) NEW
KBT Container material - if the container is a bottle, the goods are a solid dosage form (e.g. tablet) and the change is of a type listed in assurance 15 SAR 5, 10, 13, 15 & 16 C1 9D(3)
KGL Container material - clear to coloured glass O
KBL Container material - if the container is a blister pack, the goods are a solid dosage form (e.g. tablet) and the change is of a type listed in assurance 18 SAR 5, 10, 13 & 18 C1 9D(3)
KOT Container material - other than in changes KBT, KGL or KBL A - C2 9D(3)
KCL Closure SAR 5, 13 C1 9D(3)
KSL Tamper evident seal - addition (including label notice to alert consumers to presence of seal) O
KSX Tamper evident seal - removal (including removal of label notice re seal) O
KWA Inert wadding material—addition, substitution or removal where stability is not affected by the action O
KDA Desiccant - inclusion in container A - C2 9D(3)
KDX Desiccant - removal from container A - C2 9D(3)
KPP Specifications of primary pack (other than labelling) O
KSP Introduction of a measuring device (e.g. spoon, cylinder) or applicator (e.g. finger cot); this change can include graphical representation of the device on the label (copy of current & proposed label must be supplied if label is changed) SAR 5 C1 9D(3)
KMD Changes to existing measuring device (e.g. spoon, cylinder) or applicator supplied with the goods or removal of a measuring device or applicator, where other means of accurately measuring or applying the dose are readily available SAR 5 C1 9D(3)
KPA Introduction of a primary pack (no new text or graphics) SAR 5, 14 C1 9D(3)
KPI Introduction of a package insert where there is no requirement for supporting data A - C2 9D(3)
KPD Introduction of a package insert where supporting data or a justification for not providing supporting data is required A C3 9D(3)
KRI Removal of a package insert where there is no requirement for supporting data A - C2 9D(3)
KRD Removal of a package insert where supporting data or a justification for not providing supporting data is required A C3 9D(3)
KPX Removal of a primary pack SAR 5, 17 C1 9D(3)
KRP Introduction of a refill pack A - C2 9D(3)
KRR Removal of refill pack SAR - C1 9D(3)
MDA Changes in pump or pump components of meter-dose aerosol (e.g. valve material) A C2 9D(3)

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Manufacturing changes - finished product

Change codes Manufacturing changes - finished product Status A/D* Appln level Applicable section of the Act
MMA Addition or deletion of TGA licensed Australian manufacturer (includes site of manufacture) SAR 5, 9 C1 9D(3)
AMS Addition or deletion of steps of manufacture of a TGA licensed Australian manufacturer SAR 5, 9 C1 9D(3)
MOS Addition or deletion of an overseas manufacturer (includes site of manufacture) SAR 5, 9 C1 9D(3)
OMS Addition or deletion of steps of manufacture of an overseas manufacturer SAR 5, 9 C1 9D(3)
MPR Manufacturing process (other than MBS) SAR 13 C1 9D(3)
MBS Batch size for pressurised inhalation (nasal and oral respiratory) products A - C2 9D(3)
MUP

GMP clearance NUMBER update.

Note: no other change to record permitted under this code. If amending steps of manufacture use change code OMS

SAR
(fee exempt)
5 C1 9D(3)
MST Change to manufacturing site and/or process of sterile product A C2 9D(3)

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Consumer Medicine Information (CMI)

Change codes Consumer Medicine Information (CMI) Status A/D* Appln level Applicable 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 'Label 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

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Product Information (PI)

Change codes Product Information (PI) Status A/D* Appln level Applicable section of the Act
DPI Introduction of a PI for an existing product where there is no requirement for supporting data A - C2 9D(3)
DPD Introduction of a PI for an existing product where supporting data or a justification for not providing supporting data is required A C3 9D(3)
DRS Addition of more restrictive safety-related statements SRR 5, PI C1 9D(2)
DOT Changes other than the addition of more restrictive safety-related statements where there is no requirement for supporting data A - C2 9D(3)
DOD Changes other than the addition of more restrictive safety-related statements where supporting data or a justification for not providing supporting data is required A - C3 9D(3)

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Other

Change codes Other Status A/D* Appln level Applicable section of the Act
CTA Correction of ARTG record in accordance with section 9D(1) of the Therapeutic Goods Act 1989 SAR E, 5, 21 C1 9D(1)
BED Brand equivalence statement intended for PBS listing where supporting data or a justification for not providing supporting data is required A C3
BES Brand equivalence statement intended for PBS listing where there is no requirement for supporting data A C2
OTH Other changes: an application using this code must include written advice from the TGA advising the application level for the change Ask

*A/D = assurances to be given and supporting documentation required for the given status to apply. Refer to Changes Table codes for an explanation of all codes used

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