Pathways to evaluating your medicine

This guidance:

  • Explains the medicines that are evaluated via:
  • Directs you to the relevant process and/or guidance to follow to make an application for entry in the Australian Register of Therapeutic Goods (ARTG).

Prescription medicines

Medicines evaluated by Prescription Medicines Authorisation Branch:

Medicines in Part 1 Schedule 10 of the Regulations

The following medicines are in Part 1 Schedule 10 of the Therapeutic Goods Regulations 1990 and are evaluated by Prescription Medicines Authorisation Branch:

  • medicines that contain a substance in Schedule 4, 8 or 9 of the Poisons Standard or meet the criteria for inclusion in these schedules
  • a medical gas
  • a vaccine
  • an allergen, except an allergen for skin testing on unbroken skin
  • a biotechnology medicine
  • an immunoglobulin
  • a radio contrast agent, except barium sulphate preparation for radiological use
  • a radiopharmaceutical
  • a dialysis solution, except haemodialysis solution
  • a special dosage form, such as:
    • a transdermal system
    • an osmotic pump
  • an injectable medicine dosage form
  • a blood product unless coated on a therapeutic device
  • therapeutic goods referred to the Medicines Authorisation Branch for evaluation as a prescription medicine
  • an excipient in a medicine mentioned in Part 1 Schedule 10.

Higher risk OTC and complementary medicines

OTC and complementary medicines evaluated by Prescription Medicines Authorisation Branch are those that are one or more of the following:

  • treat serious medical conditions and under medical supervision
  • are not suitable for self-selection by consumers
  • have significant adverse effects, contraindications or drug interactions.

Examples of OTC medicines evaluated via Prescription Medicines Authorisation Branch include:

  • medicines containing oral nitrates for the treatment of heart disease which have higher inherent risks associated with their use
  • nasal corticosteroids and metered dose asthma inhalers at same risk level as prescription medicines
  • new transdermal nicotine patches.

Complementary medicines

Medicines evaluated by the Complementary and Over-the-counter Medicines Branch are described in Part 2 of Schedule 10 of the Therapeutic Goods Regulations 1990 provided they do not meet the criteria for mention in Schedule 4, 8 or 9 of the Poisons Standard. They are:

  • complementary medicines
  • excipients in complementary medicines
  • therapeutic goods referred to Complementary and Over-the-counter Medicines Branch for evaluation.

OTC medicines

Medicines evaluated by Complementary and Over-the-counter medicines Branch are described in Part 3 Schedule 10 of the Therapeutic Goods Regulations 1990. They include the following goods provided they do not meet the criteria for mention in Schedules 4, 8, or 9 of the Poisons Standard:

  • antiseptics
  • sunscreen preparations
  • all other therapeutic goods, except a therapeutic device, not mentioned in another Part of Schedule 10 (i.e. medicines that are not evaluated by Prescription Medicines Authorisation Branch or Complementary and Over-the-counter Medicines Branch)
  • an excipient in a medicine evaluated by Complementary and Over-the-counter medicines Branch
  • therapeutic goods that have been referred for evaluation as a non-prescription medicine.

Typical OTC medicines include non-prescription:

  • analgesics (e.g. aspirin)
  • decongestants
  • combination cough and cold medicines
  • antacids
  • antifungals
  • laxatives
  • anti-diarrhoeal medications
  • antihistamines.

Guidance on applications evaluated by OTC medicines:

Nicotine transdermal patches and nasal corticosteroids

The following changes to registered non-prescription nicotine transdermal patches and nasal corticosteroids are evaluated by OTC Medicines:

  • labelling
  • consumer medicine information
  • product information
  • packaging, other than immediate packaging
  • the brand name.

Applications to register a new name variant (an N1 'clone' application) are also evaluated by Complementary and Over-the-counter medicines Branch.

Applications to vary nicotine transdermal patches:

Applications referred to alternate pathway

We may refer an application to an alternative pathway to ensure an appropriate level of evaluation is applied to a medicine commensurate with its level of risk.

If this happens, we manage the application according to the requirements (e.g., fees, process, data requirements and evaluation time lines) of the new evaluation process.

Version history

Version Description of change Author Effective date
V1.0

  • Original publication
  • Replaces the Route of evaluation
OTC Medicines Regulatory Guidance Team November 2015