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Common Technical Document Module 1: OTC medicines

Applicable for applications lodged from 1 July 2017

10 July 2017

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Module 1.5 - Specific requirements for different types of applications

This section holds documents required for specific types of applications.

Module 1.5.1 Literature-based submission documents

Include information about literature based submissions for any N4, N5, C3 or C4 level application where the application partially or completely relies on a literature-based data set to support the application.

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

Include the following in Module 1.5.1:

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

Note

The overview and summary of reports, which includes a critical appraisal of all the papers submitted, is included in Module 2.5.

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

This section holds documents that authorise:

  • The TGA to access information of a third party sponsor for the benefit of the applicant. For example, a cross-licensing agreement between the applicant and a third party sponsor.
  • The use of proprietary information of a third party on the product documentation of the applicant. For example, a third party sponsor authorises the use of their logo on the applicants product 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 a 'parent' medicine (either a currently registered medicine or concurrently with an application for a medicine under evaluation).

What to include in a letter of authorisation

If your application is for an N1 level, or refers to or relies on the data or information of a 'parent' medicine, the letter from the third party sponsor (the sponsor of the parent medicine) must:

  • be on company letter head and include the full name and signature of a person authorised to conduct business on behalf of the applicant; the person must be listed in our client database and may be a company employee or an agent
  • authorise the TGA to use information in their registration file on behalf of the applicant of the new application
  • identify the medicine by stating its full ARTG name and AUST R number.

Module 1.5.7 - OTC medicine assurances

This section holds specific assurances required for particular OTC application levels (N1 and N2). You can also include assurances for any other OTC application type.

For N1 level applications, you must include the Assurances to accompany N1 application form completed in accordance with the requirements in the guideline for N1 applications.

For N2 level applications, you must include the Assurances to accompany N2 application form completed in accordance with the Requirements for N2 applications.

Module 1.5.8 - Umbrella brand assessment

This section holds the sponsor's assessment of the medicine name and umbrella segment against the ARGOM guideline on 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 registration application or a change application involving a new product name when:

  • your application is restricted to application level N4 / C3 and above because the umbrella segment requires higher level assessment.

Note

Use the flowchart in the application route for umbrella branded medicines to determine the assessment level for a medicine that has an umbrella segment in the medicine name.

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