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Changes to complementary medicines

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ARGCM Part A: General guidance on complementary medicine regulation in Australia

29 October 2017

Following the inclusion of a medicine on the ARTG, a sponsor may wish to change certain details held by the TGA for that medicine.

For Changes that result in 'separate and distinct' goods you are required to submit a new medicine application and a new ARTG number (AUST L or R) will be issued. However, where eligible, the new medicine will be 'grouped' under the ARTG entry of the existing medicine and assigned the same ARTG number - see the Therapeutic Goods (Groups) Order.

For other medicine changes, there are provisions in the legislation for certain variations to be made to a medicine's existing ARTG entry - refer to Variations to complementary medicines permitted under section 9D of the Act.

Please be aware that legislation is subject to change and should always be referred to for the most up to date regulatory requirements.

Changes to complementary medicines that result in 'separate and distinct' goods

Where the proposed change to the medicine will result in goods that are considered 'separate and distinct' from the existing goods, sponsors are required to submit an application for a new medicine. In certain circumstances, the new medicine may meet the criteria for grouping under the existing medicine ARTG entry.

For listed complementary medicines

Section 16 (1A) of the Act outlines those criteria which make medicines that are listed goods (other than export only medicines) separate and distinct from the existing goods:

  1. different active ingredients; or
  2. different quantities of active ingredients; or
  3. different dosage form; or
  4. such other different characteristics as the regulations prescribe;

Currently, Regulation 11 of the Regulations prescribes that different characteristics are:

  1. a different name; or
  2. different indications; or
  3. a different excipient; or
  4. for medicines that contain any restricted ingredients:
    1. a different quantity of a restricted ingredient that is an excipient; or
    2. if the restriction on a restricted ingredient relates to its concentration in a relevant medicine – a different concentration of the restricted ingredient; or
    3. if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine – different directions for use setting out a different recommended single or daily dose.

For registered complementary medicines

Section 16(1) of the Therapeutic Goods Act 1989 (the Act) outlines those criteria which make registered medicines separate and distinct from the existing goods:

  1. a different formulation, composition or design specification; or
  2. a different strength or size (disregarding pack size); or
  3. a different dosage form or model; or
  4. a different name; or
  5. different indications; or
  6. different directions for use; or
  7. a different type of container (disregarding container size).

The Therapeutic Goods (Groups) Order

Therapeutic Goods (Groups) Order No. 1 of 2001 (Groups Order) provides the circumstances in which a 'separate and distinct' medicine can be 'grouped' under the ARTG entry of the existing medicine and assigned the same AUST R or AUST L number.

A grouping is appropriate when the goods are intended to replace the currently supplied goods, enabling the transition of one product to another. However, individual products within the group remain separate and distinct products under sections 16(1) and (1A) of the Act.

Process for applying for a new listed medicine that may meet the criteria for a gazetted therapeutic goods group

All changes to existing listed medicines (other than those listed for export only) are made via the online listed medicine application and submission portal which is part of the TGA's Business Services framework. When a change to a product record is made that will result in a separate and distinct good, the application portal will, upon validation, recognise if the type of change meets the criteria for grouping.

Process for applying for a new registered medicine that may meet the criteria for a gazetted therapeutic goods group

If you consider that the proposed change to your registered complementary medicine would meet the criteria allowing grouping of different registrable therapeutic goods in the same group by using a Groups Order, you can submit a registered medicine application - grouped medicines (complementary medicines). If approved by the Delegate, the new medicine is 'grouped' in the ARTG under the same AUST R number. Should the application be refused, a rejection letter containing reasons for the decision and details of procedures for review of the decision will be provided to you.

Variations to complementary medicines permitted under section 9D of the Act

Section 9D (1), (2) and (3) of the Act provides the circumstances under which a sponsor may request an amendment to the ARTG entry for their listed or registered medicine. Briefly, the provisions under section 9D include:

  • section 9D(1) provides for correction of an ARTG entry of a medicine that is incomplete or incorrect
  • section 9D(2) provides for making certain safety-related variations to an ARTG entry of a medicine. A variation is safety-related if it reduces the patient population (such as by removing an indication), or has the effect of adding a warning or precaution (such as an adverse effect or interaction)
  • section 9D(3) provides for other variations to an ARTG entry of a medicine to be made, provided that the Delegate of the Secretary is satisfied that the change does not reduce the quality, safety or efficacy of the medicine.

Applications to change listed medicines

Sponsors make changes to listed medicines via the online listed medicine application. Refer to the Listed medicines application and submission user guide for more information. For information on the changes that can be made to listed complementary medicines and whether they will incur a fee, refer to the document Guidance on product changes in ELF 3.

There is a provision in the application and submission portal to request the same change to be made across a number of currently listed medicines. Each medicine change will incur any applicable fees.

Applications for changes to registered complementary medicines

All applications for changes to registered complementary medicines attract a processing fee. For certain applications a separate evaluation fee is also payable. Information on current fees is available on our website. Regulation 45 provides for the waiver or reduction of evaluation fees under certain circumstances.

It is a standard condition of registration that sponsors are required to notify the TGA of any changes in the information previously provided in relation to their therapeutic good. However, in specific circumstances some minor changes are not required to be notified, for example: additional analytical tests or tightening of product specifications. Changes tables for registered complementary medicines provides the possible changes to registered complementary medicines, applicable fees and the type of assurances or data required to support the application.

Chart A1 provides an overview of avenues for changing information for registered complementary medicines. This diagram is provided as general guidance and is not comprehensive. You should contact us when specific guidance relating to possible changes to your medicine is required.

Chart A1: Changing information for registered complementary medicines

overview of avenues for changing information for registered complementary medicines

This text representation of Chart A1 is provided as a list with numbered steps.

  1. Is the proposed change to your medicine:
    1. a different formulation, composition or design specification; or
    2. a different strength or size (disregarding pack size); or
    3. a different dosage form or model; or
    4. a different name; or
    5. different indications;* or
    6. different directions for use; or
    7. a different type of container (disregarding container size)?

    *Note: If the proposed change to the medicine indication is only to reduce the patient population, a variation application under section 9D(2) of the Act may be possible. Contact the TGA.

    If No, go to Step 2

    If Yes, go to Step 3

  2. Is the change of a type specified in section 9D of the Act? That is:
    • 9D(1): A variation of the information in the ARTG entry that is incomplete or incorrect?
    • 9D(2): A safety-related variation whereby it reduces the patient population or has the effect of adding a warning or precaution?
    • 9D(3): another variation to an ARTG entry of a medicine that does not reduce the quality, safety or efficacy?

    If Yes: You can submit a 9D variation to the TGA for consideration. End flowchart.

    If No: Contact TGA for advice on requirements for the proposed change. End flowchart.

  3. The medicine is considered a 'separate and distinct' good [as per Section 16(1) and of the Act].

    You are required to submit an application for a NEW medicine.

    The TGA will determine if the Groups Order is applicable.

    That is, if the new medicine intended to replace the existing medicine in use (or registered in place of the existing medicine) and the proposed change involves:

    • a change in the quantity of an ingredient that is not an active ingredient; or
    • the removal or addition of an ingredient that is used only for the purpose of fragrance, flavouring, printing ink or colouring; or
    • different indications for use and/or different directions for use; or
    • a different name.

    If Yes: The new medicine will be grouped under the ARTG entry for the existing medicine and assigned the same AUST R number. End flowchart.

    If No: New medicine with new AUST R number. End flowchart.

Process for applying for a variation to a registered complementary medicine under section 9D of the Act

Sponsors can apply for variation of a medicine using the Registered medicine variation form (complementary medicines). For most applications you will need to submit supporting documentation with the variation application form, for example: if you wish to change details of the label, you will need to send a copy of the present label and a proposed label. In some instances, certain assurances about the change will also need to be made before the application can proceed - refer to the Changes for registered complementary medicines.

Some changes affect other aspects of the medicine, which may require further clarification from the sponsor, for example: a manufacturing process change may also require change to finished product specifications. You can minimise the potential for delays by ensuring the medicine complies with all current legislative requirements.

If approved, the change to the ARTG entry is made by the TGA and the AUST R number is retained. Should the application be refused, a rejection letter containing reasons for the decision and details of procedures for review of the decision will be provided.

Where the same change is made across a number of products an individual application form is required for each product entry sought to be varied. Applicable fees are required to be paid for each product varied.

Changing information in the ARTG for 'grandfathered' products

'Grandfathered products' are those products that were available in Australia prior to the Act coming into effect in 1990. If a sponsor of a 'grandfathered' medicine wants to change information in the ARTG for their medicine, the same rules apply as for other medicines.