Preparing your biologicals application for inclusion in the Australian Register of Therapeutic Goods (ARTG)

To complete the biologicals application form, you need to have correctly classified your biological. We strongly recommend you:

• confirm your product is regulated as a biological, refer to: Understanding which therapeutic goods are regulated as biologicals
• classify your biological, refer to: Classifying biologicals
• if necessary, confirm your classification by completing the Request for advice on biologicals form and submit it to us for discussion with you.

Your application will only be accepted for evaluation if it has been classified appropriately, as defined under section 32DDA of the Therapeutic Goods Act 1989.

Pre-submission meetings are available to all sponsors considering supplying a biological.

We highly recommend a pre-submission meeting with us for all Class 3 & 4 biologicals, including for CTA applications.

If you are not already a TGA client, you need to obtain access to TGA Business Services and register both:

1. your details
2. all your manufacturers - including:
   1. all testing facilities you use for donor infectious disease testing
   2. all microbiology testing facilities
   3. sterilisation and/or irradiation facilities
   4. any packaging facilities.

All of your manufacturer's must be registered with TGA Business Services prior to completing your application form, so you can select them from our database.

As the sponsor of a Class 2, 3 or 4 biological, it is your responsibility to ensure all of your manufacturers comply with our manufacturing requirements. This applies to all:

• testing facilities you use for donor infectious disease testing
• microbiology testing facilities
• sterilisation and/or irradiation facilities
• packaging facilities.

In the dossier you need to submit evidence that all manufacturers are GMP certified by TGA or the certification process has been initiated. GMP accreditation must be approved prior to any decision on your application.

Australian manufacturers

If any of your Australian manufacturers do not already hold a current manufacturing licence, as the sponsor, you must:

• ensure they have at least started the licencing application process
• provide the manufacturer's licence application number as evidence with your biologicals submission.

Overseas manufacturers

If you are using overseas manufacturers, as the sponsor, you must:

• have at least started the GMP certification process
• provide the manufacturer's certification application number as evidence with your biologicals submission.

Time frames for licencing and clearances

You need to be aware of the timeframe involved in obtaining a manufacturing licence or clearance.

Sometimes multiple products can be included in the ARTG under a single entry.

The criteria to determine if your biologicals can be included in the ARTG as, multiple products under a single ARTG entry, is outlined in:

• Determining if your products are separate and distinct biologicals.

Check this guidance to determine whether your goods will be listed under a single ARTG entry or will need to be included separately. An application is required for each separate and distinct product.

The definition of separate and distinct goods is based on regulation 11A of the Therapeutic Goods Regulations 1990.

Some biologicals may be supplied with other therapeutic goods. Regulatory requirements differ depending on how the biological is supplied. To clarify the requirements, check:

• Supplying biologicals packaged or combined with other therapeutic goods.

Applications for inclusion of a biological on the ARTG are required to submit documentation. This requirement differs depending on the class of biological.

• Class 2, 3 and 4 biologicals are required to submit a complete a dossier together with evidence of manufacturing compliance.
• Class 1 biologicals are required to submit documentation outlined in Applying for a Class 1 biological to be added in the Australian Register of Therapeutic Goods (ARTG).

Dossier requirements

If you are applying for a Class 2, 3 or 4 biological you must submit a dossier to support the quality, safety and efficacy of your product, in accordance with the:

• Dossier requirements for Class 2, 3 and 4 biologicals.

Where specific requirements apply to only certain classes of biologicals, they are indicated in the guidance document.

Each application relates to a single ARTG entry, but multiple applications can be submitted at the same time and considered a 'simultaneous submission' where certain conditions, specified below, are met.

A single simultaneous submission can be submitted to for your multiple applications, if all applications:

• are for the same class of biological
• have the same sponsor billing address
• have the same principal manufacturer undertaking the release for supply step
• for Class 1 or Class 2 biologicals conform to the same product standards
• for Class 3 or Class 4 biologicals have the same active ingredient.

Reduction or waiver of the evaluation fees may apply to applications associated with a simultaneous submission, where part of the dossier supporting the applications is sufficiently similar for their evaluation to be abridged.

Guidance on how to submit multiple applications as a single submission are provided in the Biologicals application form - a step-by-step guide.

If the applications do not meet these criteria then you cannot make a simultaneous submission. However, if the applications are from the same sponsor they may still be treated as abridged applications.

Under the following circumstances your application may be treated as an abridged submission:

• part of the dossier supporting the applications is sufficiently similar for their evaluation to be abridged
• your cover letters for the applications refer to each other and you request that the applications be considered together
• you explain how the applications are similar.

Reduction or waiver of the evaluation fees may apply to abridged applications.