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Certifying that your listed or assessed listed medicines meet all regulatory requirements

Sponsors must certify the safety, quality and efficacy of their listed medicine. Certification will differ depending on the type of medicine you have.

This information is currently tailored to listed medicines only. This does not mean other non-prescription medicines do not have similar certification requirements.

Listed medicines are not individually evaluated by the TGA for quality, safety and efficacy before they are supplied in the marketplace.

Assessed listed medicines are evaluated by the TGA for efficacy, but not safety and quality before they are supplied in the marketplace.

Instead, sponsors must certify that their listed or assessed listed medicine meets requirements in relation to safety and quality. Listed medicine sponsors must also certify efficacy.

Sponsor certification

Sponsor certification means the sponsor 'certifies' that they have met all the required standards, requirements and conditions for entering their medicine on the Australian Register of Therapeutic Goods (ARTG). All of these requirements are legislated under section 26A (for listed medicines) or 26AB (for assessed listed medicines) of the Therapeutic Goods Act 1989 (the Act).

Sometimes we will want you to be familiar with the Therapeutic Goods Regulations 1990 ( the Regulations). You can reference both pieces of legislation to get much more detail when needed.

Listed vs assessed listed medicines

This page shows you which standards and legislative requirements you are certifying your listed medicine meets when you enter it onto the ARTG. More detail can be found reviewing section 26A of the Act.

Assessed listed certification requirements are similar, but not the same. You must review of section 26AB of the Act to see applicable certification for assessed listed medicines.

Compliance

You may have met these certifications by following our guidance and standards, see: Non-prescription medicine requirements and standards for more practical information. However, the responsibility of compliance remains with the sponsor.

If we perform a post-market review of your product and discover that your medicine does not meet your certifications, penalties can apply and in some cases we can remove your product from the ARTG, making it illegal for you to continue selling or supplying in Australia. See: Compliance actions and outcomes for more information.

Listed medicine certifications

Sponsor certification that the medicine is eligible for listing

This means you certify that:

  • the medicine has ingredients that are not required to be sterile
  • the medicine does not contain a substance included in a Schedule to the Poisons Standard (SUSMP)
  • only contain ingredients and complies with the requirements specified in the Permissible Ingredients Determination
  • uses indications that are covered by the Permissible Indications Determination and meets any specified requirements

See: Non-prescription medicine ingredient requirements

Sponsor certification that the medicine is safe for the purposes it is to be used

Certain regulatory restrictions and/or controls may be imposed to ensure that the use of a listed medicine is low risk.

For example:

The majority of these can be covered by understanding and applying requirements found in:

Sponsor certification that the medicine does not have unacceptable presentation

The presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as the content, proper use or identification of the goods. You will need appropriate evidence to support indications or claims used.

See: Labelling and advertising non-prescription medicines

Sponsor certifications relating to conforming with standards applicable to the medicine

You need to certify that you have conformed to any applicable standards for your non-prescription medicine.

See: Standards for non-prescription medicines.

Sponsor certifications relating to ingredients

Listed medicines must:

Sponsor certifications relating to advertising

Complies with requirements in the Advertising Code, the Act and Regulations:

See: Labelling and advertising non-prescription medicines.

Sponsor certifications relating to manufacturing

Certification applying to all manufacturers used:

  • Manufacturers are included in the application.
  • Sponsor (you) have written agreements with your manufacturer(s).
  • Specifications comply with any requirements in the Regulations.

Certifications for medicines manufactured overseas:

  • Where a product is imported or if any steps in the manufacture of a listed medicine take place outside Australia, the international manufacturer must hold a 
  • TGA Good Manufacturing Practice (GMP) clearance, or clearance that is accepted by the TGA. See: Overseas manufacturers

If manufactured in Australia:

  • Each step in the manufacture of a listed medicine is performed in a licenced facility.

See: Manufacturing requirements and standards for non-prescription medicines

Sponsor certifications relating to labelling

You must certify that your listed medicine:

  • complies with any requirements in the Regulations
  • does not make a claim that is inconsistent with claims in the application. For example, the indications you say you will use in your application are the only ones you can use
  • indications on the label are permitted indications and proposed to be accepted as part of inclusion on the ARTG
  • evidence is held showing quality will be maintained in accordance with the information on the label until the expiry date.

See: 

Sponsor certifications relating to indications and claims

You must certify that your listed medicine:

  • each proposed indication is a permitted indication(s) and all indication requirements are met
  • sponsor (you) have evidence that complies with requirements and supports any claim and indication

See: Non-prescription medicine indication requirements

Sponsor certification that the information included in/with the application is correct

Applicants of all listed medicines must certify that all information in the medicine’s ARTG entry is correct.

Sponsor certification that their medicine complies with any applicable matters in the Regulations

Applicants of all listed medicines must certify compliance with any other matters set out in the Regulations.

This means we want you to be certain you understand what information in the Regulations applies to your medicine and that you've met these requirements.

The Regulations hold a lot of information. It's the legal basis we use for backing up our requirements like:

  • The conditions that must be met for Australian manufacturers holding a GMP licence (Part 4 of the Regulations)
  • What conditions need to be met for a product to be considered a listed therapeutic sunscreen or a listed medicine (Section 4 of the Regulations)

Often these requirements are specified in our guidance. However, the responsibility for being compliant sits with the sponsor.

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