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Common Technical Document Module 1: OTC medicines
Applicable for applications lodged from 1 July 2017
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:
- Section 2 of the Guidelines on efficacy and safety aspects of OTC applications describes the OTC requirements for literature based submissions.
- literature based submissions.
Include the following in Module 1.5.1:
- Methodology of the literature search, including complete details of database search strategies.
- The complete search output.
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.
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.
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.