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Cover letter for registered complementary medicines

Print version

ARGCM Part D: Registered complementary medicines

29 October 2017

This guidance is to assist applicants to register a complementary medicine on the ARTG.

A letter of application (cover letter) is part of your application to register or to change the ARTG entry for your complementary medicine. In your cover letter, provide useful information regarding the nature and scope of the application.

This guidance relates to steps 2, 3, 5, 7 and 10 in the complementary medicine registration process and is to be included in Module 1 of your dossier[6], which you will prepare in Step 7 of the registration process and submit to us in Step 9 for evaluation.

Cover letter basics

Ensure your cover letter is on company letterhead and includes:

  • the purpose of the application
  • the medicine name
  • the proposed therapeutic indications
  • 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 electronic format of the dossier (e.g. DVD/CD/USB)
  • the rationale for selecting the application category. Include information that is significant for determining the application category and technical data requirements.
  • other relevant background information, such as overseas regulatory status.

Make sure the cover letter is signed by a person authorised to liaise with us on your behalf.

When to provide additional information

The cover letter also needs to notify us if:

  • you are providing a detailed scientific justification for not complying with technical data requirements and/or not adhering to guidelines and the location of each justification in your dossier
  • the medicine is a reformulation of a currently registered medicine
  • the medicine contains a new substance; state the date that you submitted the relevant application form for proposing a name
  • you have submitted a request to extend or renew a GMP clearance including
    • the date of the request
    • whether your request is a clearance extension or renewal
    • any other relevant details
  • you are requesting:
    • a reduction or waiver of the evaluation fees
    • any exemptions (e.g. S14 exemptions, advertising exemptions)

Footnote

  1. Dossier: a collection of files and documents that contains data (administrative, quality, nonclinical and clinical) relating to a therapeutic good