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Preparing an OTC application cover letter

The cover letter (letter of application) needs to provide useful information regarding the nature and scope of the application.

Include the cover letter in CTD Module 1.0.1.

Cover letter basics

Ensure that your cover letter includes the following details:

  • the medicine name (AUST R if applicable) and a description of the medicine
  • 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 format of the dossier (e.g. DVD/CD/USB)
  • a brief outline of the nature and scope of the application
  • the rationale for selecting the application level
    • include information that is significant for determining the application level and technical data requirements. For example, for N3 and N4 generic medicine applications you need to identify the originator medicine(s).
  • other relevant background information, such as overseas regulatory status.

The cover letter must be on company letterhead and signed by a person authorised to conduct business on behalf of the applicant, in accordance with CTD Module 1: OTC medicines.

When to provide additional information

The cover letter also needs to notify us if:

  • You are providing a justification for not complying with technical data requirements and not adhering to guidelines. You need to identify the location of each justification in dossier.
  • The medicine is a reformulation of a currently registered medicine.
  • The medicine contains a new substance; state the date that you submitted a Proposal for an AAN form and confirm that you have submitted the required data.
  • The medicine includes an ingredient that has an AAN but is not approved for the proposed use. Confirm that you have submitted the required data.
  • You have submitted a request to extend or renew a GMP clearance; state the date of the request and any other relevant details.
  • You are requesting:
    • a reduction or waiver of the evaluation fees
    • any exemptions (e.g. S14 exemptions, advertising exemptions).
  • You are providing the optional OTC analytical validation summary form
    • include this form as an attachment to the cover letter.

Applications to change a medicine

For applications to change a registered OTC medicine, the cover letter needs to:

  • Describe all of the change(s) in your own words, including reasons or justification for the change. Do not restate the description in the changes code table.
    • If your justification for the change is based on the approved details for another registered OTC medicine, you need to identify the medicine and provide relevant information (e.g. copies of the approved labels or product information).
  • Identify where supporting data for each change is located in the dossier.

    For applications to make multiple changes (including C1 applications); present the information describing the changes, including labelling changes, in a table.

    Suitable headings are:

    • Current registration details
    • proposed registration details
    • reason/justification for change
    • reference to supporting document
    • change code/application level.

    If you are making multiple changes to the text and layout of a label, each change needs to be separately listed in the table.

  • State which pack sizes the change applies to.
  • Refer to the TGA's prior endorsement if you are using any 'OT' change codes (e.g. OT1). You also need to include a copy of our email as an attachment to the cover letter.
  • Notify us if there are any ongoing applications with the TGA to make other changes to the same medicine.
  • Notify us of any ongoing or previous applications to make the same change to an S4 presentation of the medicine.

Version history

Version Description of change Author Effective date

Original publication OTC Medicines Regulatory Guidance Team 1 March 2016