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Changing an OTC medicine: using the Changes Tables
Version 2.4, 4 December 2017
This guidance is for sponsors planning to change a registered over-the-counter (OTC) medicine. 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.
Related information and guidance
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'.
- You are required to make the relevant assurances corresponding to the assurance code when you submit your application in eBusiness 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 included in the Changes Table.
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).
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)
- we will determine the appropriate level for the application based on the principals outlined in the Application Categorisation Framework
- 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.