All listed medicines must comply with applicable standards included in the Therapeutic Goods Act 1989 (the Act) before they can be included on the ARTG. Standards ensure safety, quality, efficacy and consistency in the medicines and ingredients supplied to the market.
These include both standards declared by the Minister under section 10 of the Act or any ‘default standards’. Ministerial Standards include Therapeutic Goods Orders (TGOs) such as TGO 92 – Standard for Labels of non-prescription medicines and TGO 78 – Standard for Tablets and Capsules. Default standards are defined as the British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia – National Formulary.
Where there is no default standard available for an ingredient available for use in listed medicines, the TGA provides Compositional Guidelines that summarise the description, tests and acceptance criteria that need to be met for each ingredient.
In some circumstances, sponsors can seek consent under sections 14 and 14A of the Act to import, export or supply medicines that do not confirm with a part of a prescribed standard. Sponsors will need to provide evidence that demonstrates that the safety, quality, and efficacy of the medicine will not be adversely affected. Consent will generally only be granted for a maximum of 2 years to either allow existing supplies to be sold or the issue preventing compliance with the standard to be rectified.
Follow the links below to learn more about your regulatory requirements: