Listing a complementary medicine on the ARTG

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ARGCM Part B: Listed complementary medicines

29 October 2017

Listed medicines included on the Australian Register of Therapeutic Goods (ARTG) via a streamlined online listed medicine application and submission portal which is part of the TGA Business Services framework.

All necessary tools required to lodge, change and maintain an application for a listed medicine are accessible via TGA Business Services. The Listed medicines application and submission user guide fully describes the listed medicine application and submission process.

Step 1: Obtain access to TGA Business Services and the online application portal

To access the application portal you will require a user name and password. You must first submit an Organisation details form to obtain a client identification number. Having obtained a client identification number, you can submit a TGA Business Services Access Request Form to become the 'Business Administrator' for your company and then can apply for user accounts for yourself and other personnel in your company.

For further information about obtaining a client identification number or gaining access to TGA Business Services, contact the TGA by phone 1800 010 624 or email ebs@health.gov.au.

Step 2: Medicine details entered in the TGA Business Services application portal

The Listed medicines application and submission user guide provides a step-by-step description on how to enter your medicine details.

Step 3: Application passes validation in TGA Business Services application portal

During validation, the application and all related sub-documents are checked against the listed medicine business rules. The application must pass validation before it can be submitted to the TGA.

Successful validation of an application does not mean that the product has been approved by the TGA, nor that the product meets all the requirements for listing. The TGA Business Services application portal is a tool designed to allow electronic submission of an application for a listed medicine. The onus of responsibility is with the sponsor of the medicine to certify, upon submission, that the goods that are the subject of the application meet all the requirements of listing.

If you have problems with your application, you can contact the TGA by email: listed.medicines@health.gov.au or by phone: 1800 119 312.

Step 4: Submission

When the application has passed validation, the applicant (who will become the sponsor of the medicine) must electronically sign a statutory declaration certifying (as per Part 26 A of the Act) that the application meets all conditions of listing and that the information provided in the application is correct.

The application can then be submitted.

Step 5: Application fees paid

Fees for a listing application are non-refundable and non-transferable and must be paid within 14 days of the application being submitted to the TGA. If payment is not made within 14 days, you will receive an email notifying you that the application has been rejected. Should you wish to continue, you will need to draft a new application.

Step 6: TGA processing of the application

Once payment is finalised:

  • the application is recorded on the ARTG
  • the medicine is assigned an AUST L number
  • a 'Certificate of medicine listing' is generated for the medicine.

Step 7: Finalisation

The sponsor of the medicine:

  • is notified by email of application completion and provided with the AUST L number
  • downloads the 'Certificate of medicine listing' from TGA Business Services
  • receives the 'Conditions of listing' letter from the TGA
  • can market the product.

If your listed medicine is selected for a random compliance review, you will receive a notice requiring you to provide specified information to the TGA (under section 31 of the Act). Usually, you will be given 20 working days to respond. Failure to provide the information within 20 working days after the date specified in the notice is grounds for cancelling the medicine from the ARTG and it is an offence to fail to respond to the notice or to provide information in response that is false or misleading in a material particular. For more information refer to Listed complementary medicine compliance reviews.

The product details will usually be viewable on the TGA Business Services website the day after the information has been recorded on the ARTG.