Applying for a Class 1 biological to be added in the Australian Register of Therapeutic Goods (ARTG)

To supply a Class 1 biological, ensure your biological is listed in Schedule 16 of the Therapeutic Goods Regulations 1990:

1. Check the current Schedule 16 instrument lists your good as a Class 1 biological
   1. If your biological is not listed then contact us for further advice
   2. If your biological is listed then continue to step 2.

Currently, only Faecal Microbiota Transplant (FMT) products are listed in Schedule 16. For Class 1 FMT products, all of the following must apply:

• it is not be advertised to consumers
• the starting material is to be collected under the supervision or direction, or in accordance with the requirements, of a medical practitioner registered, in a State or internal Territory, as a medical practitioner
• each later step in the manufacture of it is to be carried out in a hospital by, or under the supervision or direction of, the practitioner (unless the step relates to the storage or testing of the biological, in which case it may instead be carried out by a person under a contract with the hospital in a State or internal Territory)
• it is for use in a recipient who is a patient of the hospital with the recipient being under the clinical care of the practitioner.

2. Include your biological on the ARTG
   1. Prepare your documentation for inclusion of a Class 1 biological in the ARTG.
   2. Follow the biologicals application form - a step-by-step guide to submit the application form with your documentation.

Complete and submit the application form on the TGA Business Services website to include your Class 1 biologicals on the ARTG for supply in Australia.

You need to pay the application fee at the time you submit the application. Following submission, the acknowledgement of successful submission invites you to print a copy of your invoice.

For information on payment methods go to:

• Payment options

We will not process your application until you have paid your application fee. For details of the current fees go to:

• Schedule of fees and charges

Sponsors do not need to submit additional documentation and do not need GMP licences or clearances for biological manufacturers of Class 1 biologicals.

The TGA will review the information provided in the application form and may request corrections be made to that information to conform with the requirements.

Certification

Sponsors who are applying to have a Class 1 biological included on the ARTG must accept the certification when submitting their validated application form on the TGA Business Services website.

This certifies that the biological complies the requirements for a Class 1 biological listed in s32DA of the Therapeutic Goods Act 1989 (the Act). This includes but is not limited to:

• The product is a Class 1 biological listed in Schedule 16 of the Regulations.
• It is safe for the purposes for which it is to be used.
• It conforms with any relevant mandatory standards, this includes
• Therapeutic Goods Order No. 87 General requirements for the labelling of biologicals for all biologicals, and
• Therapeutic Goods (Standard for Faecal Microbiota Transplant Products) (TGO 105) Order 2020 for FMT products.
• The biological complies with all prescribed quality or safety criteria that are applicable to it.
• The biological does not contain substances that are prohibited imports for the purposes of the Customs Act 1901.

To include a Class 1 biological on the ARTG, the TGA may request information (under s32JA of the Act) in relation to the product or manufacturing process, including information about whether the biological complies with applicable standards.

Once the application has been processed, you will be sent a notification letter detailing your product, the Conditions of Inclusion relevant to your product and instructions on how to obtain your ARTG Certificate.

If you supply biologicals in Australia then you need to know your responsibilities. This page will help you understand your responsibilities after your Class 1 biological is included on the Register.

Maintaining your ARTG entries

Being the sponsor of an entry in the ARTG, you need to:

• continue to satisfy the conditions that were part of the approval for inclusion on the ARTG
• provide information to us about your product, if requested

Paying your fees and charges

When you have a biological included on the ARTG, you will need to pay an annual charge.

Fees and payments provides an overview and summary of fees and charges for biologicals outlines the fees and annual charges for sponsoring biologicals.

Biovigilance responsibilities

Biovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other problem related to biologicals.

Biovigilance responsibilities include:

• adverse event reporting requirements
• record-keeping requirements

To meet legislated requirements, you need a biovigilance system, which is used to fulfil the tasks and responsibilities associated with the detection, assessment, understanding and prevention of adverse effects of biologicals.

Recall responsibilities

As a sponsor of a therapeutic good, you have ongoing responsibilities to ensure you are prepared for a recall and able to respond appropriately to complaints and problem reports:

• Roles in recalling therapeutic goods

Advertising biologicals

Biologicals are not allowed to be advertised to the public.