Preparing an over-the-counter (OTC) medicine application cover letter

Use this guide to prepare a cover letter for an over-the-counter (OTC) medicine application. Your 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:

• medicine name (AUST R if applicable) and a description of the medicine
• sponsor name
• the regulatory contact (must be an authorised person)
• the IT contact for the submission (if different from the regulatory contact)
• date of submission and submission ID (if known)
• approximate submission size and how the data has been submitted (e.g. by email, uploaded in TBS or in GovTEAMS)
• whether payment of fees has been forwarded directly to TGA finance
• 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)
• a reference to any prior written advice you have received from the TGA that relates to the application: include a copy of the correspondence as an attachment to the cover letter
• 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 the application is in eCTD or NEES format

When the dossier is in eCTD or NEES format, include in your cover letter:

• in the subject line:
  • e-ID
  • sequence number
  • related sequence number (consistent with the XML envelope)
• a description of the software used to check the files for viruses
  • a statement confirming the submission is virus-free
• the validation tool and version used
  • address and justify any validation warnings (if submitting in NeeS).

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. Do not restate the description in the changes code table.
• Include reasons or justification for the change. 
  • 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 and 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.