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Changes for registered complementary medicines

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ARGCM Part D: Registered complementary medicines

29 October 2017

The information below is for sponsors planning to change a registered complementary medicine. It:

  • contains the complementary medicines changes tables, which are a tool to help you obtain essential regulatory information about your change including:
    • whether approval is needed to make the change
    • notification requests
    • the section of the Therapeutic Goods Act 1989 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 complementary medicines changes tables.

Change application levels

Applications to change an ARTG entry for a registered complementary medicine are categorised into five levels (CN–C4) based on increasing risk.

It is important that you select the correct change codes in the change code tables as these will determine the application level for you.

Notification request (CN)

Notification changes are those changes where their implementation would not affect the established quality, safety or efficacy of the medicine. These have been determined by TGA to pose a very low risk.

Notifications include changes to the quality and non-quality aspects of a medicine and do not require assessment of safety, efficacy and/or quality data (or a justification for not providing such data). After making an application to TGA requesting the variation and receiving an automated acknowledgment of acceptance of the submission, sponsors can implement the changes immediately.

Notification changes identified in the Changes Table as application level N (CN).

As part of the Government's complementary medicine reforms, TGA will be consulting on change application levels C1-C4 for registered complementary medicines in late 2017.

Application level 1 (C1)

Changes identified in the Changes Table as application level C1.

C1 applications do not need safety, efficacy and/or quality data or a justification for not providing the data.

Application level 2 (C2)

Changes identified in the Changes Table as application level C2.

C2 applications:

  • may require assessment of quality data
  • do not need safety and/or efficacy data or a justification for not providing the data

Application level 3 (C3)

Changes identified in the Changes Table as application level C3.

C3 applications:

  • include changes to the quality, safety and/or efficacy of a medicine
  • include changes to the medicine name where the new name requires a higher level of assessment, such as where there is an identified risk associated with an umbrella branding segment
  • require assessment of supporting safety and/or efficacy data or a justification for not providing the data

Application level 4 (C4)

Changes identified in the Changes Table as application level C4.

C4 applications:

  • include changes to the safety and/or efficacy aspects of the medicine
  • require assessment of safety and/or efficacy data (clinical and/or toxicological) to support the proposed changes or a justification for not providing the data

Identifying changes in the tables

Before you make a change to your complementary medicine, you will need to locate each planned change in the Changes tables 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'.

Make sure you make the assurances corresponding to the assurance code when you submit your application in TGA Business Services.

If you cannot find your proposed change in the changes table or you cannot meet the conditions for the change, go to Changes not in the table.

Example

If you are planning to delete an indication and as a consequence you need to change the directions for use, identify both the change to the indications and 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 if approval is needed

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

Changes requiring approval

You need TGA approval before changing the medicine if the status code for the proposed change is one of the following:

  • SRR (safety related request). Application made under subsection 9D(2) of the Therapeutic Goods Act 1989
  • SAR (self-assessable request). Application made under subsection 9D(1) or 9D(3) of the Therapeutic Goods Act 1989
  • A (approvable changes). Application made under subsection 9D(3) or section 23 of the Therapeutic Goods Act 1989

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 coded change that requires TGA approval corresponds to a particular application level based on risk. If a change requires TGA approval, you must wait to receive approval before making that change.

Making more than one change in one application

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

How to apply for approval to change a registered complementary medicine

To apply for approval to make the change, follow the online applications for registered complementary medicines guidance.

Changes not requiring approval

If the status code for a change is 'O', you can make the change without submitting an application for TGA approval.

You cannot select changes with status code 'O' when you complete an application in TGA Business Services because you do not need TGA approval.

Changes requiring a new ARTG entry

If the status code is NEW (new application required), you will need to apply for a new ARTG entry under section 23 of the Therapeutic Goods Act 1989.

Separate and distinct good

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

The 'new' (separate and distinct) good must be entered separately 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 Therapeutic Goods Act 1989 and require TGA approval before you can make the change(s). (Most are status code A.)

If a new complementary 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 complementary medicine and obtain a new AUST R number.

Changes not in the tables

If the change you plan to make is not listed in the changes tables, contact Complementary medicines because absence of a code does not mean you can make the change to the ARTG record without notifying the TGA.

If we determine that the change you propose needs to be approved by us first and there is not an appropriate code in the changes tables, we will email you:

  • endorsing the use of the 'other' change code
  • advising you of the appropriate level for the application and the section of the Therapeutic Goods Act 1989 that applies to the change

In your application, you need to:

  • refer to this email in your application cover letter
  • include our email in the dossier