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Module 1.3 - Medicine information and labelling

Applicable for applications lodged from 1 July 2017
Last updated

This section holds documents relating to the presentation and packaging of the medicine(s) including:

You can also include labelling and product documentation of other medicines in Module 1.3. For example:

  • labelling of 'parent' medicines (for N1 applications)
  • labels of other medicines included in the dossier to assist the evaluator.

Note

Medicine information and labelling for:

Module 1.3.1 Product information and package insert

This module is for both the product information and the package inserts.

Product information

You must include product information (PI) with your application when:

  • Your application, which results in a separate and distinct good under section 16 of the Act, is for a restricted medicine.
  • Required by the Secretary under section 23 of the Act.
  • Your application to change a registered medicine involves a change to the PI. For example, an update to the adverse events section of the PI.
  • You submit an N1 application and the 'parent' medicine includes a PI. You will also need to:
  • You intend to supply a PI for the medicine.
Note

The PI must be in the form for providing product information if the medicine is a restricted medicine or a medicine where the secretary requires a PI.

Product information based on an approved PI

If your PI is based on an existing PI, you will need to include both the marked up and clean version.

The 'marked-up' PI

Include the marked-up version in module 1.3.1.2 and identify all additions, deletions or changes using 'track changes'. You will need to:

  • Justify any differences between the existing and the proposed PI. You can include the justification for the differences either as comments within the document (i.e. as part of the tracked changed document) or in a table in the cover letter.
  • Identify the location within the dossier of the evidence to support the differences.
The clean version of the PI

Include the 'clean' PI in module 1.3.1.1. The 'clean' copy incorporates all the changes proposed but removes the version marks and comments.

Refer to the Product Information section in the Guidelines on presentation aspects of OTC applications for guidance on compiling a PI.

Package insert

Include a package insert in Module 1.3.1.3 with:

  • Applications for medicines that need a package insert. For example, when labelling information does not fit on the label.
  • Applications that involve changing the existing package insert.
  • N1 level applications where the 'parent' medicine includes a package insert. In this case you need to include both:
    • the package insert for the proposed medicine
    • the most recently approved package insert of the 'parent' medicine in module 1.3.1.
  • Applications where you intend to supply a package insert with the medicine.

If your application involves a change to the current package insert, include both the current package insert of the medicine and a draft copy of the new package insert. You will need to:

  • Highlight the differences between the current and proposed package insert.
  • Justify any differences between the current and proposed package insert - the justification for the differences could be included as comments within the document (i.e. as part of the tracked changed document) or included in a table in the cover letter.
  • Identify the location within the dossier of the evidence to support the differences.
Further information and guidance

Package inserts section in the Guidelines on presentation aspects of OTC applications.

Product information and package inserts for other medicines

If your application refers to product information and/or package inserts of other relevant medicines, include these documents in module 1.3.1. For example, your product information is based on the PI of an originator medicine. Include the PI of the originator medicine in module 1.3.1.

Module 1.3.2 Consumer medicines information

Include a CMI when your application:

  • Will result in a separate and distinct good under section 16 of the Act (e.g. registering a new generic medicine or applying to change the proprietary name of an existing medicine) AND where the medicine is included in Schedule 3 of the current Poisons Standard.
  • Is for a change that affects the CMI. For example, an application to include important safety information in the PI which needs to be reflected in the CMI
  • Is an N1 level application and the 'parent' medicine includes a CMI. Include the most recently approved CMI of the 'parent' medicine in module 1.3.2.

Further information and guidance

Consumer Medicine Information section in the Guidelines on presentation aspects of OTC applications.

Consumer medicine information based on an existing CMI

If the CMI is based on an existing CMI, include two versions of the CMI:

  • Include the 'marked-up' CMI in module 1.3.2.2 and identify all additions, deletions or changes using 'track changes'. You will need to justify any differences between the existing and the proposed CMI.
  • Include a 'clean' CMI in module 1.3.2.1. The 'clean' copy incorporates all the changes proposed but removes the version marks and comments.

Consumer medicine information for other medicines

If your application refers to the CMI of other relevant medicines, include those CMI documents in module 1.3.2.

Module 1.3.3 Label mock-ups and specimens

Include copies of all draft medicine labels with all applications to:

  • register new OTC medicines
  • change the labelling of existing OTC medicines.

Where the only difference in labelling between pack sizes is the quantity, only one set of labels needs to be submitted provided an assurance to that effect is submitted with the application.

If your application involves a change to the current medicine label include both the current label and a draft copy of the new label and:

  • highlight the differences between the current and proposed labels
  • justify any differences between the current and proposed labels - the justification for the differences could be included in a table in the cover letter
  • identify the location within the dossier of the evidence to support the differences.

Further guidance

Product name and the Labelling in Guidelines on presentation aspects of OTC applications.

Labels for other medicines

Include labels of other relevant medicines in Module 1.3.3 when the application:

  • is for an umbrella branded medicine that requires a higher level assessment (include the labels of all other medicines in the umbrella range)
  • is at the N1 level (include copies of the most recently approved parent labels)
  • refers to labels of other medicines.

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