CTD Module 1: Administrative information for assessed listed medicines

Use this section to include:

• Your application cover letter.
• Your responses to our requests we make for information during the screening/evaluation of your application.

Any other correspondence you may have received from us before submitting your application. For example, an email from us about:

• data requirements for a new application
• using a particular application level
• format for the application as agreed at a pre-submission meeting (if organised).

Module 1.0.1 Application cover letter

A cover letter is part of your application to list or change the ARTG entry for your medicine. In your cover letter, provide useful information regarding the nature and scope of the application.

Include the cover letter in Module 1.0.1 for all applications.

The cover letter must:

• be on a company letterhead
• be signed by a person authorised to conduct business on behalf of the applicant. The person must be listed on our client database and may be a company employee or an agent. The AU eCTD specification: Module 1 and regional information contains information about electronic signatures.
• include all the necessary information for a cover letter:
  • the purpose of the application
  • the medicine name
  • the proposed indications
  • the contact person and sponsor name
  • the date of submission and submission ID (if known)
  • whether payment of fees has been forwarded directly to TGA finance
  • the electronic format of the dossier (e.g. USB)
  • the rationale for selecting the application category. Include information that is significant for determining the application category and technical data requirements
  • other relevant background information, such as overseas regulatory status.

The cover letter must also notify us if:

• you are providing a detailed scientific justification for not complying with technical data requirements and/or not adhering to guidelines, and the location of each justification in your dossier
• the medicine is a reformulation of a currently listed or registered medicine
• you have submitted a request to extend or renew a GMP clearance including:
  • the date of the request
  • whether your request is a clearance extension or renewal
  • any other relevant details
• you are proposing to use a restricted representation on your medicine label
• you are requesting:
  • a reduction or waiver of the evaluation fees
  • any exemptions (e.g. consent under section 14 to not complying with an applicable standard, advertising exemptions).

Cover letter justifications

Where you are providing a detailed scientific justification for not complying with technical data requirements and/or not adhering to guidelines, provide a scientific justification under the relevant heading to explain why you are not adhering to the requirement or guideline. Your cover letter should notify us if you are providing a justification and the location of each justification in your dossier. 

We will assess the content and merit of a justification (i.e. whether the alternative approach is in fact valid) during the evaluation phase.

Module 1.0.3 Responses to requests for information

Only use this section to include your responses to requests for information that we may send during screening or the evaluation of your application.

You will not need to include a document in this section when you first submit your dossier.

Preparing your response to a request for information

Prepare a letter or an email that includes:

• the submission ID
• the medicine name, active ingredient details and dosage form of the medicine
• a comprehensive response to each question in our request.

If you are referring to any documents submitted as part of a previous application, include the submission ID.

Referencing CTD documents

When you reference CTD documents in your response, make sure you include detailed references to the CTD module, the tab identifier and the page number. For example, ‘See Module 5, 5.3.5.1: Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication, p 44’.

The comprehensive table of contents is a complete list of all documents in the dossier, arranged by module, and with location references for each document. The table of contents can have hyperlinks that navigate to the headings in the dossier.

Locate the main table of contents in the top level folder of the dossier.

This section contains forms and certification documents for assessed listed medicine applications.

• Do not include the application form in Module 1. The application form is submitted online in the Electronic Listing Facility (ELF) system, which is accessed through TGA Business Services - external site.

For information: Using reports from Comparable Overseas Bodies

The TGA’s Comparable Overseas Body (COB) report-based process allows technical evaluation reports from identified bodies to be used by TGA to assess applications against the Australian requirements.  For the criteria to identify COBs, the current list of COBs and the process for using COB reports refer to Comparable Overseas Bodies (COBs) for complementary medicines.

If you are using a COB report, you must complete and submit the relevant Comparable Overseas Bodies (COB) checklist as part of Module 1.2 of your dossier submission. This checklist will enable the TGA to assess whether the application meets the requirements of the selected application category. If certain criteria are not met, the application must include appropriate justification.

Module 1.2.3 Patent certification

You will need to provide one of the following forms under section 26B of the Act for all new listings including formulation changes, changes in trade name, extensions of indications, before a new approved listing can be included in the ARTG:

• Certification in relation to patents required in relation to registration or listing under Sections 25, 26 and 26A of the Therapeutic Goods Act 1989
• Notification to the Secretary that certification under section 26B(1) of the Therapeutic Goods Act 1989 is not required

You can either:

• Include the certification or notification in Module 1.2.3 if you are able to provide it when you submit your dossier; or
• Send the certification or notification to nonprescriptionmedicines@health.gov.au at any time after you lodge the application with the submission ID clearly visible and clearly identified as Module 1.2.3 Patent certification.

Module 1.2.5 Form for approval to use a restricted representation

If you are proposing to use a restricted representation on your medicine label, note this in your cover letter.

• Do not complete and submit the Application for approval to use a restricted representation in advertising form - external site with your registration application.

Please note that approval for the use of a restricted representation in advertising can only be considered once the assessed listed medicine is listed in the ARTG. 

Any proposed restricted representation must be consistent with the product's accepted indications or intended purpose, as per its ARTG entry; and/or any mandatory warning or cautionary statements which are required to be included in the product packaging/labelling in order to satisfy other regulatory requirements.

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

• Labels
• Package inserts.

Module 1.3.3 Label mock-ups and/or specimens

Include copies of all draft medicine labels with applications for:

• new assessed listed medicines
• changes to the labelling of existing assessed listed medicines.

When the quantity (e.g. number of tablets) is the only difference in labels for different pack sizes:

• you only need to submit one label; and
• include an assurance that this is the only difference between the pack sizes.

Refer to the Guidelines for using the TGA assessed claim on medicine labels if you are including the TGA assessed claim on your label.

Application involving a change to the medicine label

If your application involves a change to the current medicine label, include both the current approved 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
• include the justification for the differences in a table in Module 1.3.3
• identify the location within the dossier of the evidence to support the differences.

Labels of other medicines

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

• is a L(A)1 application (include copies of the most recently approved originator labels)
• refers to labels of other medicines.

This section is optional for assessed listed medicines.

This section holds documents about the experts who reviewed the supporting data for the application, and prepared the summaries and overviews that constitute Module 2.

If an expert report is provided it should be cross-referenced by page number or hyperlinked to the submission.

The author of an Expert Report should have appropriate qualifications and experience relevant to the subject matter. For example, the expert for a mineral or vitamin supplement application should have qualifications and expertise in nutritional epidemiology. You may wish to include information about the clinical expert in Module 1.4.3, such as:

• A declaration form completed and signed by the expert that both:
  • declares the extent, if any, of their professional or other involvement with the dossier owner
  • confirms that the report has been prepared by them or if not, any assistance provided and by whom.
• A curriculum vitae (CV) outlining the expert’s educational background, training and occupational experience.

This section holds documents required for specific types of applications. You can include the request under section 14 to not comply with an applicable standard in Module 1.5.

Module 1.5.1 Literature-based submission documents

This section applies to applications that partially or completely rely on literature-based data.

Include the following in Module 1.5.1:

• Methodology of the literature search, including complete details of database search strategies.
• The complete search output.

You will need to refer to the following guidance when preparing the documentation:

• the ‘Literature search report’ section in the Assessed listed medicines evidence guidelines
• the guidance on Literature-based submissions for listed medicines and registered complementary medicines.

Module 1.5.5 Co-marketed medicines declarations (letters of authorisation)

This section holds documents that authorise TGA to:

• access information of a third party sponsor for the benefit of the applicant e.g. a cross-licensing agreement between the applicant and a third party sponsor
• use the proprietary information for the applicant’s medicine e.g. a third party sponsor authorises the use of their logo on the applicant’s medicine labelling.

You must include a letter of authorisation in Module 1.5.5 when your application refers to, or relies on, the data or information held on file of an originator medicine.

What to include in a letter of authorisation

If your application is an L(A)1 level application, or refers to or relies on the data or information of an originator medicine, make sure the letter from the sponsor of the identical medicine:

• is on company letter head and includes the full name and signature of a person authorised to conduct business on behalf of the applicant. The person must be in our client database and may be a company employee or an agent;
• authorises TGA to use information in their registration file on behalf of the applicant of the new application; and
• identifies the medicine by stating its full ARTG name and AUST L(A) number.

Module 1.5.7 Assessed listed medicine assurances

This section holds specific assurances required for L(A)1 applications. You can also include assurances for any other application type.

For L(A)1 level applications, you must include an assurance stating that all aspects of the proposed medicine are identical to the originator medicine, other than specifically permitted differences listed in Table 3 of the Assessed listed medicines evidence guidelines.

Module 1.5.8 Umbrella brand assessment

This section holds the sponsor’s assessment of the medicine name and umbrella segment against umbrella/family brand names.

You must include your assessment of the proposed medicine name and umbrella segment addressing each of the points identified in the umbrella/family brand names guideline for any new assessed listed medicine application or a change application involving a new product name when there is a higher risk associated with the use of the umbrella segment. These higher risk applications will be restricted to application level L(A)3 / C2 because the umbrella segment requires higher level assessment.

This section is for documents relating to pre-submission meetings and identifies how you have addressed any issues raised during the meeting in the dossier. Note that TGA ratified minutes are the official record of the meeting.

Module 1.7.1 Details of any pre-submission meetings outcomes

Only include information in this section if you had a pre-submission meeting with us and there were issues that you needed to address as part of your application.

Include a copy of the pre-submission meeting record.

Provide the following details:

• the date(s) of the meeting(s)
• the outcomes arising from the meeting(s) requiring applicant action
• how the outcomes from the meeting(s) have been addressed in the dossier
• any agreements reached at the meeting.

Meetings include all relevant meetings in any format (i.e. face to face, teleconference or videoconference) requested by either an applicant or the TGA.

Ensure the information in Module 1.7.1 accurately reflects the meeting(s) and any outcomes you needed to address in your application.

All meetings provide guidance only and outcomes are without prejudice and are not considered binding on TGA.

Module 1.7.2 Details of any additional data

We usually only accept additional data if the medicine is critical to the Australian community to address emergency or safety situations.

You should only need to submit relevant safety data and data that we may request during the evaluation of an application.

If we agree to accept additional data during the evaluation, include:

• A copy of our agreement to accept the additional data
• The agreed date for sending the data
• Details of the additional data we agreed to accept.

The additional data:

• need to be well defined and relate to a particular and limited aspect of the application
• are not intended to facilitate inadequate or premature applications.

Module 1.9.1 Summary of a bioavailability or bioequivalence study

You must include the summary of a bioavailability or a bioequivalence study for any L(A)2 or L(A)3 level application that includes a bioavailability or bioequivalence study in the dossier.

To prepare a summary of a bioavailability or bioequivalence study:

• download the Summary of a Bioavailability or Bioequivalence Study form
• complete a separate form for each study
• include the form(s) in Module 1.9.1.

Related guidance

Refer to section on Biopharmaceutic and pharmacokinetic studies in the Assessed listed medicines evidence guidelines.

Module 1.9.2 Justification for not providing biopharmaceutic studies

You must include a justification for not providing biopharmaceutic studies when biopharmaceutic studies are required (refer to the section on Justifications in the Assessed listed medicines evidence guidelines).

Further guidance

Justification for not complying with technical requirements in the Mandatory requirements for an assessed listed medicines application.

The justification for not providing biopharmaceutic studies must:

• address all the relevant points in justification for not submitting biopharmaceutic data
• include any other relevant information
• include any references used to support the justification in Module 5.

This section holds documents relating to foreign regulatory information for a new medicine, or significant changes to a listed medicine. We may ask you to provide information on the foreign regulatory status during the screening or evaluation phase of an application.

The TGA’s Comparable Overseas Body (COB) report-based process allows technical evaluation reports from identified bodies to be used by TGA to assess applications against the Australian requirements.  For the criteria to identify COBs, the current list of COBs and the process for using COB reports refer to Comparable Overseas Bodies (COBs) for complementary medicines.

Module 1.11.1 Foreign regulatory status

Details of the foreign regulatory status may be included if the same or similar applications have been submitted in other countries or the medicine is marketed in other countries.

Relevant information for inclusion in this module would include:

• a list of countries in which a similar application has been submitted
• a list of countries in which the proposed medicine or a similar medicine(s) is marketed
• details of approvals, deferrals, withdrawals or rejections of the application in other countries.

Module 1.11.2 Foreign product information

You may include foreign product information if the same or similar applications have been submitted in other countries or the medicine is marketed in other countries.

Include a copy of the overseas document that is equivalent to the Australian Product Information.

Module 1.11.3 Data similarities and differences

You may include data similarities if the same or similar applications have been submitted in other countries or the medicine is marketed in other countries.

Prepare a summary of the similarities/differences between the data in this application and the data packages submitted in the overseas country. Identify and account for any significant differences.

Module 1.11.4 Foreign evaluation reports

For assessed listed medicines, you may include a foreign evaluation report for some L(A)2 applications if a regulatory authority in another country has evaluated the same or similar applications and the evaluation report is available.

What to include

• Obtain and include a full un-redacted English copy of the evaluation report in this Module.
• If applicable, prepare a summary of the similarities/differences between the data in this application and the data packages submitted in the overseas country. Identify and account for any significant differences. Justify how the foreign evaluation report meets TGA technical requirements and provide a gap analysis if required.