CTD Module 1: registered complementary medicines

Print version

ARGCM Part D: Registered complementary medicines

29 October 2017

Module 1of the Common Technical Document (CTD) has been tailored to accommodate the needs and requirements for complementary medicines.

It is a standardised format for collating and organising the administrative information part of the dossier to support an application to either:

  • register a complementary medicine under section 23 of the Therapeutic Goods Act 1989 by following the complementary medicine registration process
  • change the details of an ARTG entry for a complementary medicine under section 9D of the Therapeutic Goods Act 1989 by following the process to change a complementary medicine.

Sections intentionally deleted

We have deleted the following sections as they do not apply to complementary medicine applications:

  • 1.6 Master files and certificates of suitability
  • 1.8 Pharmacovigilance
  • 1.10 Information relating to paediatrics
  • 1.12 Antibiotic resistance data

Make sure all the document(s) meet the general dossier requirements.

Open all | Close all
If you want to print all details, you need to Open all before you print.

Use this section to include:

  • Your application cover letter.
  • Your responses to our requests we make for information during the screening (Step 10) or during evaluation (Step 11 of the registration process).
  • Any other correspondence you may have received from us before submitting your application. For example, an email from us about:
    • data requirements for a registration application
    • using a particular code and application level for a change application
    • format for the application as agreed at the pre submission meeting.

Cover letter (letter of application)

Follow the guidance for the cover letter.

Make sure the cover letter is on company letterhead and:

  • includes the information required of your application
  • is signed by a person listed in your company details as authorised to conduct business with us. The 'AU eCTD specification: Module 1 and regional information' contains information about electronic signatures.

Include the cover letter in Module 1.0.1 for all applications.

Make sure the new document(s) meet the general dossier requirements.

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

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 individual files (documents) in the dossier.

This section contains the patent certification documents for medicine applications.

Do not include:

  • application forms for complementary medicines in Module 1.

1.2.3 Patent certification

Provide either a patent certification or patent notification under section 26B(1) of the Therapeutic Goods Act 1989 for all new registrations, including:

  • formulation changes
  • changes in trade name
  • extensions of indications
  • changes to the directions for use.

Submit the relevant patent certification or notification:

  • 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.
  • Send the certification or notification to complementary.medicines@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.

1.2.5 Form for approval to use a restricted representation

If you are using a restricted representation on your medicine label, include in Module 1.2.5:

Please note that approval for the use of a restricted representation can only be considered once the complementary medicine is registered on the ARTG.

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

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

  • labelling of the originator medicine (RCM 1 applications)
  • labels of other medicines included in the dossier to assist the evaluator.

1.3.1 Product Information and package insert

Module 1.3.1 is for both the Product Information (PI) and the package inserts.

Product Information

The PI contains technical information intended for healthcare practitioners and must not include promotional material.

For more information, go to:

A PI is required for restricted medicines, which are those registered complementary medicines that are:

  • subject to Schedule 3 of the Poisons Standard

    OR

  • contained in a therapeutic good mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990 (other than in items 1(b) and 14).

Include Product Information (PI) with your application when you:

  • intend to supply a PI for the medicine
  • submit a RCM 1 application and the originator medicine includes a PI. For these applications also:
    • include a copy of the most recently approved PI of the originator medicine in Module 1.3.1
  • apply to change a registered complementary medicine that involves a change to the PI. For example, an update to the adverse events section of the PI

Even where a PI is not mandatory, you may choose to include one to provide more information on the medicine. However, the requirements for PI documents are the same.

Product information based on an approved PI

If your PI is based on an existing one, provide both the clean and marked –up versions.

The clean version of the PI

Include the 'clean' copy of the PI in Module 1.3.1.1.

This copy incorporates all the proposed changes, but has no version marks and comments.

The 'marked up' PI

Include the marked-up version in Module 1.3.1.2.

This copy contains all the track changes including changes, additions and deletions.

Justify any differences between the existing and the proposed PI. You can include the justification for the differences as either comments within the document (i.e. as part of the tracked changed document) or a table in the cover letter.

Identify the location within the dossier of the evidence to support the differences.

Package insert

All package inserts for registered medicines are part of product labelling and require TGA approval.

Include a package insert with:

  • Applications for medicines that either:
    • need a package insert. For example, when labelling information does not fit on the label.
    • involve changing the existing package insert. Include both the current package insert of the medicine and a draft copy of the new package insert.
  • RCM 1 applications where the originator 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 originator medicine.
  • Applications where you intend to supply a package insert with the medicine.

Highlight the differences between the current and proposed package insert.

Justify any differences between the current and proposed package insert – Include the justification either:

  • as comments within the document (i.e. as part of the tracked changed document)
  • in a table in the cover letter.

Identify the location within the dossier of the evidence to support the differences.

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, if your Product Information is based on the PI of another medicine, include the PI of that medicine in Module 1.3.1.

1.3.2 Consumer Medicines Information

The CMI:

  • contains general information about the medicine
  • is written in plain English (for the consumer)
  • must be consistent with the PI
  • must comply with the requirements specified in Schedule 13 of the Therapeutic Goods Regulations 1990 (although the information does not have to be set out in the same order as the Schedule).
  • cannot include promotional material.

Include a CMI when your application is for a:

  • new ARTG entry
  • separate and distinct good[7] (e.g. changing the proprietary name of an existing medicine that is in Schedule 3 of the Poisons Standard)
  • medicine that falls under Schedule 3 of the Poisons Standard
  • 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)
  • a RCM 1 application and the originator medicine includes a CMI. Include the most recently approved CMI of the originator medicine in Module 1.3.2.

Footnoe

  1. A separate and distinct good is defined under section 16 of the Therapeutic Goods Act as:

    a different formulation, composition or design specification; strength or size, dosage form or model; name; indications; directions for use; container type (disregarding container size).

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.
    • Identify all additions, deletions or changes using 'track changes'.
    • Justify any differences between the existing and the proposed CMI.
  • 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.

1.3.3 Label mock-ups and/or specimens

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

  • register new complementary medicines
  • change the labelling of a registered complementary medicine.

When the quantity is the only difference in labels for different pack sizes:

  • submit one set of labels.
  • include an assurance that this is the only difference between the pack sizes.

Application involving a change to the 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
  • include the justification for the differences in a table in the cover letter
  • 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 RCM 1 (include copies of the most recently approved originator labels)
  • refers to labels of other 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.

Include information about the:

  • quality expert in Module 1.4.1 for applications that include any subsection of Module 2.3 in the dossier.
  • safety nonclinical expert in Module 1.4.2 for applications that include any subsection of Module 2.4 and/or 2.6 in the dossier.
  • clinical expert in Module 1.4.3 for applications that include subsection of Module 2.5 and/or 2.7 in the dossier.

Expert reports

Include expert reports which:

  • are cross-referenced by page number or hyperlinked to the submission
  • provide separate critical appraisals of both the:
    • quality and manufacturing
    • nonclinical and clinical efficacy and safety of the medicine.

Authors of expert reports

The author of an Expert Report should have appropriate qualifications and experience relevant to the subject matter. E.g. the expert for a mineral or vitamin supplement application should have qualifications and expertise in nutritional epidemiology.

For each expert responsible for compiling Module 1, provide:

  • A declaration 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.

You may find the Module 1.4 form useful for this purpose.

This section holds documents required for specific types of applications.

You can include the optional OTC analytical validation summary form, form for an approval of a restricted representation and request for section 14 exemptions in Module 1.5.

We have intentionally omitted subsections 1.5.2, 1.5.3 and 1.5.4.

1.5.1 Literature-based submission documents

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

Follow the guidance on literature based submissions.

Prepare and include the following in Module 1.5.1:

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

Include the overview summary reports in Module 2.5.

This section holds documents that authorise TGA to both:

  • 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 applicants medicine labelling.

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 for an RCM1, 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
  • Identifies the medicine by stating its full ARTG name and AUST R number.

This section of Module 1 is for documents relating to pre-submission meetings and identifies how you have addressed any issues raised during the meeting in the dossier.

1.7.1 Pre-submission meeting outcomes

Only include information in this section if you had a pre-submission meeting with us (Step 7 of the registration process) and there were issues that you needed to address as part of your application.

Include a copy of the pre-submission meeting outcomes.

In preparing the details of how you have addressed any issues that arose from the pre submission meeting, you need to identify:

  • 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 TGA.

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

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

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 in Step 11 of the registration process, 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:

  • needs to be well defined and relate to a particular and limited aspect of the application
  • may affect target timeframes
  • are not intended to facilitate inadequate or premature applications.

1.9.1 Bioavailability or bioequivalence

Include the summary of a bioavailability or a bioequivalence study for RCM 4 and RCM 5 applications that includes a bioavailability or bioequivalence study in the dossier.

To prepare a summary of a bioavailability or bioequivalence study:

Justifications when you do not have data

You can submit a scientific justification when biopharmaceutic studies are required but not provided under the Module 5 Reports of biopharmaceutic studies (5.3.1).

Ensure you:

This section holds documents relating to foreign regulatory information for a new medicine, or significant changes to a registered medicine.

It is not usually needed for complementary medicines but it may be relevant in certain circumstances. For example, an application for a new medicine with a new active ingredient (a category RCM5 application) where simultaneous applications are being submitted in other countries.

We may ask you to provide information on the foreign regulatory status during the screening or evaluation phase of an application.

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.

Include:

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

1.11.2 Foreign product information

You may include foreign product information for some RCM4, RCM5, C3 or C4 level applications 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 equivalent overseas document to the Australian Product Information. For example, a data sheet from New Zealand or the prescribing information from USA.

1.11.3 Data similarities and differences

You may include data similarities for some category RCM4, RCM5 or level C3 or C4 applications if the same or similar applications 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.

1.11.4 Foreign evaluation reports

As part of the Government's complementary medicine reforms, TGA will be consulting on the acceptance of reports from comparable overseas regulators for registered complementary medicines in late 2017.

You may include a foreign evaluation report for some category RCM4, RCM5 or level C3 or C4 applications if another regulatory authority in another country has evaluated the same or similar applications and the evaluation report is available.

Obtain a copy of the relevant evaluation report and include a complete copy of the report.