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CTD Module 1

3 August 2020

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1.3 Medicine information and labelling

Overview

This section of Module 1 holds multiple documents relating to the presentation and packaging of the medicine(s).

Summary of requirements

Documentation
Section Description Category 1/COR report-based Variations to quality only (e.g. Category 3)
New registration Variation New registration Variation
1.3.1.1 Product information - clean mandatory mandatory mandatory requirement defined by the regulatory activity
1.3.1.2 Product information - annotated requirement defined by the regulatory activity mandatory mandatory requirement defined by the regulatory activity
1.3.1.3 Product information - approved requirement defined by the regulatory activity requirement defined by the regulatory activity requirement defined by the regulatory activity requirement defined by the regulatory activity
1.3.1.4 Package insert requirement defined by the regulatory activity requirement defined by the regulatory activity requirement defined by the regulatory activity requirement defined by the regulatory activity
1.3.2.1 Consumer medicines information - clean mandatory requirement defined by the regulatory activity mandatory requirement defined by the regulatory activity
1.3.2.2 Consumer medicines information - annotated requirement defined by the regulatory activity requirement defined by the regulatory activity mandatory requirement defined by the regulatory activity
1.3.2.3 Consumer medicines information - approved requirement defined by the regulatory activity requirement defined by the regulatory activity requirement defined by the regulatory activity requirement defined by the regulatory activity
1.3.3.1 Label mock-ups and specimens - clean mandatory requirement defined by the regulatory activity mandatory requirement defined by the regulatory activity
1.3.3.2 Label mock-ups and specimens - annotated requirement defined by the regulatory activity requirement defined by the regulatory activity mandatory requirement defined by the regulatory activity
1.3.3.3 Label mock-ups and specimens - approved requirement defined by the regulatory activity mandatory mandatory requirement defined by the regulatory activity

Module 1.3.1 Product information and package insert

When to include the product information and package insert

Product information (PI)

Include in all regulatory activities which:

  • result in one or more new ARTG entries under section 16 of the Act, for example:
    • new chemical entity
    • change in formulation
    • additional trade name
    • change in trade name
    • new container type
  • relate to a variation that will result in a change to the PI, for example:
    • a category 1 application to update the clinical trials section of the PI
    • a category 3 application to change the storage conditions of the medicine which will be implemented immediately after approval
    • a change in the scheduling of the medicine.

Package insert

Include a proposed package insert with all regulatory activities which:

  • result in one or more new ARTG entries by reason of being a separate and distinct good under section 16 of the Act where a package insert is required (for example, injectables) or is proposed
  • relate to a variation that will:
    • result in a change to an existing package insert
    • necessitate the inclusion of a package insert.
Important information

The Form for providing product information (PI) is approved by a delegate of the Secretary of the Department of Health under subsection 7D(1) of the Therapeutic Goods Act 1989(the Act). The form specifies the format and content of PIs that accompany applications to register or vary the registration of certain medicines. For more information on the PI requirements see the TGA website.

The information below provides advice on how to submit PIs in the approved format.

How to prepare product information and the package insert

Regulatory activities resulting in a new register entry/entries

Include a draft PI in the dossier:

  • for regulatory activities to register a new medicine covered by the Restricted Medicine Specification
  • where the applicant has been given a notice that an Australian PI is to be included with the dossier.

Draft the proposed Australian PI using the form and format approved under subsection 7D(1) of the Act and supporting TGA Guidance on Product Information.

If the PI for a new registration is based on a PI that complies with the previous form, the new PI must be provided in the current form and format specified by subsection 7D(1) of the Act.

The information below is provided to assist applicants in producing an Australian PI and is to be read in conjunction with the published information on the Form for providing product information..

All other regulatory activities

Ensure the Australian PI is updated and maintained based on the format and contents specified in guidance for PI and package inserts.

Product information

Ensure all information in the PI is supported by evidence provided in the dossier.

If the PI is based on an existing PI, include:

  • a 'clean' Australian PI in Module 1.3.1.1. This clean copy incorporates all the changes proposed but removes the revision marks and comments.
  • the 'marked-up' (annotated) Australian PI in Module 1.3.1.2. This 'marked-up' copy clearly shows all additions, deletions or changes using 'track changes' when based on, or amending, an existing Australian PI.
  • the existing 'approved' Australian PI in Module 1.3.1.3. This approved copy is the current approved version of the PI and should be updated each time a new version of the PI is approved.
  • When submitting a reformatted PI, the existing 'approved' Australian PI should be reformatted, prior to making the 'marked-up' copy. The reformatted version of the approved PI should also be included in Module 1.3.1.2.
Regulatory activities resulting in a variation to an existing PI

Include the necessary information in the 'marked-up' document to direct evaluators to the evidence base in the dossier that supports the changes or new information being proposed in the PI, either as an explanatory comment box or as an attached table.

Regulatory activities relating to multiple PIs

Provide both 'marked-up' and clean versions of each PI.

Applications for additional trade name

Use the Australian PI of the original product as the basis for the 'marked-up' Australian PI.

If the PI for an additional trade name is based on an existing PI in the previous format, the new PI must be provided in the current form and format approved under subsection 7D(1) of the Act.

Applications for new generic medicine

Clearly identify and justify all differences between the Australian reference product PI and the generic PI, other than the trade name and the applicant's name and address, on the 'marked-up' PI.

If the PI for a new generic medicine is based on an existing PI in the previous format, the new PI must be provided in the current form and format approved under subsection 7D(1) of the Act.

Applications requiring an amendment to an existing PI

Where there is an amendment to an existing PI:

  • Check the document to confirm it is current and incorporates any changes approved by the TGA before amending an existing Australian PI.
  • The 'marked-up' document must include the necessary information to direct evaluators to the evidence base in the dossier that supports the changes or new information being proposed in the PI, either as an explanatory comment box or as an attached table.
  • The existing 'approved' PI must be included in Module 1.3.1.3.
  • If updating the PI to align with the current form and format approved under subsection 7D(1) of the Act, then the existing 'approved' Australian PI should be reformatted, prior to making the 'marked-up' copy. The reformatted version of the approved PI, as well as the 'marked-up' copy, should both be included in Module 1.3.1.2.
Package inserts

Package inserts

  • must be consistent with:
    • the label
    • PI
    • consumer medicines information (CMI) documents and requirements
  • are required when obligatory labelling information does not fit on the label and must be provided on a package insert
  • do not require a section with information on clinical trials
  • must not be promotional. They can only contain information about the safe and appropriate use of the goods
  • are included at Module 1.3.1.4.
For products for parenteral use

The PI must be supplied as a package insert.

For self-administered injections

The CMI may be included in addition to the PI as a package insert.

Module 1.3.2 Consumer medicines information

When to include consumer medicine information

Include consumer medicine information for all regulated activities which:

  • result in a separate and distinct good under section 16 of the Act
  • relate to a variation that will result in a change to the CMI

For example, an application to include important safety information in the PI and which needs to be reflected in the CMI.

How to prepare consumer medicine information

The CMI:

If the CMI is based on an existing CMI, include:

  • A 'clean' CMI in Module 1.3.2.1. This clean copy incorporates all the changes proposed but removes the revision marks and comments.
  • The 'marked-up' (annotated) CMI in Module 1.3.2.2. This 'marked-up' copy clearly shows all additions, deletions or changes using 'track changes' when based on, or amending, an existing CMI.
  • The existing 'approved' CMI in Module 1.3.2.3. This copy is the current version of the CMI and should be updated each time a new version of the CMI is finalised. Note that the CMI must align with the PI.
Note:

CMIs are referred to as 'patient information' in the legislation.

In addition to the requirements of the Regulations, the TGA strongly encourages applicants to follow Writing about medicines for people: Usability guidelines for consumer medicine information when developing a CMI. These guidelines outline the correct procedure for writing, testing, implementing and monitoring CMI.

It is the applicant's responsibility under the Regulations to ensure that the CMI remains consistent with the PI and the format specified in the Regulations.

Legislation

Schedule 12 of the Therapeutic Goods Regulations 1990 requires the CMI to be:

  • clearly legible
  • written in language that will easily be understood by patients
  • consistent with product information (within the meaning of section 9D of the Act) about the product
  • include the matters that are listed in Schedule 12.

Module 1.3.3 Label mock-ups and specimens

When to include labels

Include the proposed Australian labelling with all regulatory activities that:

  • result in one or more new ARTG entries under section 16 of the Act, for example:
    • new chemical entity
    • new strength
    • additional trade name
    • change in trade name
    • new container type
  • seek a variation that will result in:
    • a change to the labelling
    • the creation of a new label
    • for example, a category 3 application to change the storage conditions or applicant details.

How to prepare labels

Ensure all Australian labels comply with the relevant Therapeutic Goods Orders unless otherwise exempted.

Each label (for example, carton labels, container labels, package inserts) should be provided in Module 1.3.3 as individual PDF files. The samples should:

  • include all panels, if applicable
  • quote the scale and actual size dimensions; and
  • reflect the actual colour proposed for use.

Ensure labels are provided for every separate and distinct good in the submission.

If the labels are based on existing labels, include:

  • the 'clean' Australian labels in Module 1.3.3.1. This clean copy incorporates all the changes proposed but removes the revision marks and comments.
  • the 'marked-up' (annotated) Australian labels in Module 1.3.3.2. This 'marked-up' copy clearly shows all additions, deletions or changes using 'track changes' when based on, or amending, an existing Australian label.
  • the existing 'approved' Australian labels in Module 1.3.3.3. This 'approved' copy is the current approved version of the each label and should be updated each time a new version of a label is approved.
If batch number and expiry date are to be printed on the label during packaging
  • Include a statement to this effect with the labels.
Label colours
  • Ensure label design takes into account the fact that dispensers and patients may have varying degrees of colour blindness and impaired vision.
Separate and distinct medicines with multiple pack sizes
  • Where a separate and distinct medicine has multiple pack sizes and the labelling is identical for each pack size (with the exception of the pack size identifier), provide one label with a declaration that the labelling for the other pack sizes is identical to the label provided.
New registrations where provisional AUST R is unknown
  • Show the proposed location for the AUST R number on the packaging using 'AUST R XXXXXX'.
New registrations and packaging modifications
  • Include a description of the proposed packaging(s) of the product and the pack size(s) in Module 3.2.P.7.
Legislation

Labels are evaluated under:

  • Section 25(1) of the Therapeutic Goods Act 1989 (the Act) requires that the Secretary must evaluate goods having regarded to:
    1. whether the presentation of the goods is acceptable
    2. whether the goods conform to any standard applicable to the goods, or any requirements relating to advertising applicable under part 5-1 or under the Regulations.
  • Section 3 of the Act defines 'standards' to include:
    • 'a standard that is constituted by the matters specified in an order under section 10 that is applicable to the goods'.

Therapeutic Goods Orders made under section 10 of the Act setting out requirements for medicine labels. Labels are assessed against the requirements in these orders.

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