Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Registration of a new over-the-counter medicine (N1-N5)

Australia · Therapeutic Goods Administration · Over-the-counter

Non-prescription applicationMedium confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

6 requirements

Application fee

A$27,500

FY2026-27

What is the Registration of a new over-the-counter medicine in Australia?

Non-prescription medicines are registered at one of five risk-based levels. N1 covers clones of an evaluated parent. N2 covers medicines that meet an OTC monograph. N3 and N4 cover generics, and N4 needs safety or efficacy data. N5 covers extensions and new chemical entities. A new registered OTC medicine. Changes to registered OTC medicines use separate change levels.

How much does the Registration of a new over-the-counter medicine cost?

The otc n5 evaluation fee is A$27,500 for FY2026-27.

What are the steps of the Registration of a new over-the-counter medicine?

1. Choose the application level; 2. Submit the CTD dossier; 3. Screening for an effective application; 4. Evaluation and decision.

Outcome: Registration in the Australian Register of Therapeutic Goods.

Legal basis: Therapeutic Goods Act 1989, section 23; Therapeutic Goods Regulations 1990, Schedule 9 Part 3 (fees)

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

Official step durations

Steps

In order, with the official target for each step

1. Choose the application levelThe applicant identifies the right level, N1 to N5, using the categorisation framework.
2. Submit the CTD dossierThe applicant sends an electronic dossier in common technical document structure, with GMP clearance for overseas manufacturers.
3. Screening for an effective applicationThe agency checks that the application meets the mandatory requirements.
4. Evaluation and decisionThe agency evaluates the data for the level and decides.

Requirements

What the applicant must provide or meet

Eligibility

N1: clone(in some cases)A clone of a fully evaluated parent medicine, or a flavour, fragrance or colour variant within set limits.
N2: monograph(in some cases)

Official time targets

Targets, not actual review times

No time targets published.

Fees

Official amounts in the local currency

Fee	Amount
OTC N5 evaluation feeApplication · FY2026-27	A$27,500
OTC N4 evaluation feeApplication · FY2026-27	A$18,699
OTC N3 evaluation feeApplication · FY2026-27	A$11,245
OTC N2 evaluation feeApplication · FY2026-27	A$7,297

Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (18 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.

Registration of a new over-the-counter medicine (N1-N5)

What is the Registration of a new over-the-counter medicine in Australia?

How much does the Registration of a new over-the-counter medicine cost?

What are the steps of the Registration of a new over-the-counter medicine?

How the pathway works

Timeline with clock stops

Steps

Requirements

Eligibility

Official time targets

Fees

Quality and manufacturing

Clinical data

Other

Inspection