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Australian regulatory guidelines for OTC medicines (ARGOM) (Nov 2012)

Version 1.4

9 November 2012

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11. Changes to OTC medicines

The current Australian Regulatory Guidelines for Over-the-counter Medicines (ARGOM) is being reviewed and updated by the TGA.

Selected chapters have been removed and replaced with references to the appendices. This document will remain as the guidance document until it can be fully replaced by the updated ARGOM, i.e. chapters such as Chapter 2, 3, 7, 8, 10 and 11 will remain in effect until such time it is replaced.

Is notification or prior approval required?

Following the inclusion of your product as a registered OTC medicine in the Australian Register of Therapeutic Goods (ARTG), you may wish to change certain details held by the TGA. Influences such as product stability, manufacturer changes and developing marketing strategies may dictate changes to product details which were approved at the time of the product's inclusion in the ARTG.

It is a condition of registration of your goods that you notify the TGA of any changes in information that may have been relevant to a decision to register the goods.

The Changes table in this Chapter sets out the steps that you must take before proceeding with a change. Note that the Therapeutic Goods Act 1989 provides for penalties where a change is implemented without the approval of the TGA (see subsection 22(3) of the Act).

About this document

While this document gives summary information about the legislation, you are strongly advised to refer to the legislation itself for complete information on the implications for your product. This document refers only to registered OTC medicines. It does not apply to listed medicines, complementary medicines or medicines of the type evaluated by the Drug Safety and Evaluation Branch.

Which form do I fill in?

Applications for variation of an existing product should be made on the Registered medicine variation form (OTC). Applications for registration of a new product should be made on the New medicine registration application form (OTC). These forms are available on the OTC medicines page of the TGA website.

How much will it cost?

All applications directed to the Non-Prescription Medicines Branch, whether requiring notification or prior approval, will attract an application fee. For applications which require approval, a separate evaluation fee is payable. Information on current fees is available on the TGA website or from the TGA Publications Office – Freecall 1800 020 653.

The Therapeutic Goods Regulations provide for the waiver or reduction of evaluation fees under certain circumstances. If the change to your product is such that you feel you are eligible for a waiver or reduction of the evaluation fee you should pay the full fee at the time of application and include a request for waiver/reduction with the application. Reductions or waivers are not granted as a matter of course. Each application is judged on its own merits. If approved, the appropriate amount will be refunded by the Business Management Unit. Processing delays may result if the correct fees are not paid at the time of application.

Refer to Regulation 45 of the Therapeutic Goods Regulations for the criteria applying to the waiver and/or reduction of fees.

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

Some changes may render the changed 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 'new' goods, although technically separate and distinct from the present goods, may be 'grouped' in the same register entry as the existing goods. If the 'new' goods are separate and distinct and the Groups Order does not apply, you will need to submit a new application for registration of the goods.

See Groups Order (below) for a summary of the provisions of the Therapeutic Goods (Groups) Order.

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What else do I need to send?

For applications that require approval, and for some applications that require notification, you will need to submit further documentation with the variation form. Some supporting documentation requirements are self-evident. If you wish to change details of the label, for example, you will need to send a copy of the present label and a draft copy of the new label, highlighting the changes (note that finished artwork is not necessary at this stage).

In other cases, what is required as supporting documentation may not be so evident. If you have consulted the various references and are still unsure, contact the staff of the OTC Medicines Section.

In some instances, certain assurances about the change will also need to be made before the application can proceed. Where these are required, details are given in the Changes table. Note that it is your responsibility to ensure that the required assurances are given in your application. If they are not given, the change may require prior approval, rather than notification.

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

Generally, only the requested change 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 not generally hold up processing of the application.

Obviously, some flexibility will be necessary, as it may be in the interests of both the TGA and the sponsor to have all outstanding issues resolved before the change is implemented.

Sponsors should be aware that sometimes a proposed change might involve additional consequential changes (eg. 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 changes for many products?

If you wish to implement an identical change across a range of similar products, only one application form may need to be completed in certain cases. An example is the notification of a change of the same principal manufacturer (licensed) for a range of registered products.

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

If you cannot find a description of your proposed change in the Changes table, contact the staff of the OTC Medicines Section. The absence of your proposed change does not imply that you may proceed with the change without notifying us or seeking prior approval of the change.

Acknowledgment of application

You will be sent an acknowledgment by the Business Management Unit (BMU) in response to all submissions for changes which require either notification or prior approval. For changes requiring notification, you need not wait until you receive the acknowledgment of your notification before implementing the change.

For changes that require prior approval, a letter of approval, signed by the delegate of the Secretary, is sent. It is important that you do not proceed with this type of change until you receive the approval letter. Should your application be refused, a rejection letter containing details of procedures for review of the decision will be sent.

Groups Order - summary

The 'Groups Order' specifies the circumstances in which 'separate and distinct' therapeutic goods can be 'grouped' in the same ARTG entry (ie. under the same AUST R number).

Section 16 of the Therapeutic Goods Act 1989 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.

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, you 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 drug products) 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 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 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

The following codes should be read in conjunction with the Changes table (below). Assurances should be made in writing, signed and dated by an authorised person, and should accompany the variation form. Note that the exact wording, as given here, should be used. Failure to make the relevant assurances that are required for notifiable changes may render the change approvable.

Status codes

Code Description
NEW New application for registration required.
A Prior approval required before proceeding with the change.
N Notification to the Non-Prescription Medicines Branch before proceeding with the change, provided that the required supporting documentation has been supplied.
O No prior approval or notification 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 Contact OTC Medicines Section

Documentation and assurance codes

Code Description
E Evidence to support the change where an ARTG entry is to be corrected.
G GMP pre-clearance certificate
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.
T The submission is accompanied by written requests to effect the change from both the existing and the proposed sponsors.
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 SUSDP schedule (or 'N' for unscheduled goods) for the new pack size(s) is/are stated in 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 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.
8. The change is in compliance with a requirement introduced in the most recent version or amendment of the Standard for the Uniform Scheduling of Drugs and Poisons.
9. The nominated manufacturer is licensed to manufacture goods of this type.
10. The container type (as defined in TGA Approved Terminology for Drugs) 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 Non-Prescription Medicines Branch 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.
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 Therapeutic Goods Act 1989.

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Changes table

Label changes (including package insert)
Label changes (including package insert) Status A/D*
GPN Proprietary name (if grouping applies) A 1, 2, L
PIN Proprietary name (if grouping doesn't apply) NEW -
GIN New therapeutic indications (if grouping applies) A 1, 3, L
PTI 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
LIS Therapeutic indications - removal of sub-set of indications from label N 5, L
LIR Therapeutic indications - addition of registered indications to label A 5, L
GDU Directions for use - eg. dosage instructions (if grouping applies) (See also LIW) A 1, 3, L
LDU Directions for use (if grouping doesn't apply) NEW -
PSC Recommended storage conditions - more restrictive N 5
PST Recommended storage conditions - less restrictive A -
LSR Addition of more restrictive safety-related statements N 5, L
LSF Changes on label (signal headings, warning statements) in compliance with new SUSDP requirements, where the change in scheduling is from 'Prescription Only Medicine' (Schedule 4) to a lower schedule A -
LSU Changes on label (signal headings, warning statements) in compliance with new SUSDP requirements, other than LSF N 5, 8, L
LLO Changes to bring a label into compliance with the Labelling Order - other than changes to the proprietary name, indications or directions for use N 5, 7, L
LLR Addition of a required representation to a label (Part 2 of Schedule 2 to the Therapeutic Goods Regulations) N 5, 7, L
LCF Colour, font, type size only (no change in label copy) N 5, L
LGR Introduction of new graphics/icons (other than as specified in change SSP) A -
LFO Reformatting of pre-existing text (ie. moving of blocks of text and not rewording - see LIW, LRT) N 5, L
LRT Rewording of pre-existing text without altering meaning (other than indications or directions for use - see LIW) A -
LDT Deletion or addition of text to the label (eg. 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) A -
LOC Other changes 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.

* 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.

Product detail changes
Product detail changes Status A/D*
PIN Proprietary name (if grouping doesn't apply) NEW -
PSZ Pack size - other than liquids/semi-solids (see PLS) or metered dose aerosols (see PMZ) (see also KBT, KGL, KBL and KOT) N 5, 6, 10, L, P
PLS Pack size - liquids/semi-solids N 5, 6, 10, 13, L, P
PMZ Pack size - metered dose aerosols A -
GIN New therapeutic indications (if grouping applies) A 1, 3, L
PTI New therapeutic indications (if grouping doesn't apply) NEW -
PDF Dosage form (as defined in TGA Standard Terminology**) NEW -
PVI Visual identification N 5, 13, 19
PSL Shelf life - increase (other than in change PSP) A -
PSR Shelf life - decrease N 5
PSP Shelf life - increase (in accordance with an approved stability testing protocol for that product) N 5, 11, 20
PPR Approval of a stability testing protocol for a specific product A -
PSC Recommended storage conditions - more restrictive N 5
PST Recommended storage conditions - less restrictive A -
PMI Sterility status/technique A -

* 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.

** TGA approved terminology for medicines

Formulation changes - active ingredients
Formulation changes - active ingredients Status A/D*
AAI Addition of active ingredient NEW -
AAD Deletion of active ingredient NEW -
AAA Amount of an active ingredient (see also Actives/excipients - variations in weight per batch in Chapter 4B, Formulation) NEW -
AOV Overage - decrease N 5
AOA Overage - increase A -
GPA Change to amount of an excipient ingredient within a proprietary ingredient which contains an active substance (eg. a direct-compression paracetamol mix) (if grouping applies) A 1
API Change to a proprietary ingredient which contains an active ingredient, other than as above in change GPA NEW -

* 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.

Product detail changes
Product detail changes Status A/D*
GPI Removal and/or addition of a fragrance, flavour, printing ink or colouring agent (if grouping applies), other than change ERT A 1, 13
ERE 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'.

N 5
EAD Addition of excipient other than those above in change GPI NEW -
EDE Deletion of excipient other than those above in change GPI NEW -
GEX Amount of excipient (if grouping applies) A 1
EAM Amount of excipient (if grouping doesn't apply - see also Actives/ excipients - variations in weight per batch in Chapter 4B, Formulation) NEW -
EST Type of starch N 5, 12
EWI Change to ingredients within a proprietary ingredient which is a flavour, fragrance, printing ink or colour (proprietary ingredient has same name) N 5, 13
EWA Change to ingredients within a proprietary ingredient which is an excipient (other than above in change EWI) A -

* 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.

Quality control changes - finished product specifications
Quality control changes - finished product specifications Status A/D*
QFX Specification ranges - more restrictive O -
QFE Specification ranges - less restrictive A -
QFT Addition of an extra test O -
QFU Deletion of an existing test A -
QFA Analytical method - to comply with amendments to a standard (eg. 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 -
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 -

* 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.

Quality control changes - starting material specifications
Quality control changes - starting material specifications Status A/D*
QSX Range - more restrictive O -
QSE Range - less restrictive A -
QST Addition of an extra test O -
QSU Deletion of an existing test A -
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 -
QSM Manufacturer of starting material (specifications unchanged) O -
QSS Supplier of starting material O -

* 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.

Packaging changes
Packaging changes Status A/D*
KCT Container type (as defined in TGA Standard Terminology7) NEW -
KBT Container material - if the container is a bottle, the goods are a solid dosage form (eg. tablet) and the change is of a type listed in assurance 15 N 5, 10, 13, 15 & 16
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 (eg. tablet) and the change is of a type listed in assurance 18 N 5, 10, 13 & 18
KOT Container material - other than in changes KBT, KGL or KBL A -
KCL Closure N 5, 13
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 -
KDX Desiccant - removal from container A -
KPP Specifications of primary pack (other than labelling) O -
KSP Introduction of a measuring device (eg. spoon, cylinder) or applicator (eg. finger cot) N 5
KMD Changes to existing measuring device (eg. 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 N 5
KPA Introduction of a primary pack (no new text or graphics) N 5, 14
KPI Introduction of a package insert A -
KRI Removal of a package insert A -
Changes to package insert (see 'Label changes' section)
KPX Removal of a primary pack N 5, 17
KRP Introduction of a refill pack A -
KRR Removal of refill pack N -

* 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.

Manufacturing changes - finished product
Manufacturing changes - finished product Status A/D*
MMA TGA licensed Australian manufacturer (includes site of manufacture) N 5, 9
MOS Overseas manufacturer (includes site of manufacture), if GMP pre-clearance certificate provided N 5, G
MOP Overseas manufacturer (includes site of manufacture), if GMP pre-clearance not provided A -
MPR Manufacturing process (other than MBS) N 13
MBS Batch size for pressurised inhalation (nasal and oral respiratory) products A -

* 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.

Consumer Medicine Information (CMI)
Consumer Medicine Information (CMI) Status A/D*
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 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 -

* 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.

Product Information (PI)
Product Information (PI) Status A/D*
DPI Introduction of a PI for an existing product A -
DRS Addition of more restrictive safety-related statements N 5, PI
DOT Changes other than the addition of more restrictive safety-related statements A -

* 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.

Other
Other Status A/D*
CTA Correction of ARTG record in accordance with section 9D(1) of the Therapeutic Goods Act 1989 N E, 5, 21

* 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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