Supply a prescription medicine
Information on how to legally supply a prescription medicine in Australia. This includes how to register the product in the Australian Register of Therapeutic Goods (ARTG) and guidance to understand the ongoing responsibilities.
In order for a prescription medicine to be registered in the Australian Register of Therapeutic Goods (ARTG) a sponsoring company (the sponsor) is required to submit an application to the Therapeutic Goods Administration (TGA).
An application to register a prescription medicine consists of:
- data that support the quality, safety and efficacy of the product for its intended use
- completed forms
- the payment of fees.
Australia has a 2-tiered system for the regulation of medicines.
- Higher risk medicines must be registered in the ARTG, which involves evaluating the quality, safety and effectiveness of the product.
- Lower risk medicines containing pre-approved, low-risk ingredients and that make limited claims can be listed in the ARTG.
For details on manufacturing prescription medicines go to Manufacture a medicine.
Steps to register a prescription medicine
Before you apply to register a prescription medicine in the ARTG, please read Prescription medicines registration process. This document explains the mandatory requirements, including:
- supporting documentation
- application pathways
- pre-submission planning
- application milestones
- concurrent applications
- mandatory requirements for an effective application.
- Biopharmaceutic studies
- Risk management plans for medicines and biologicals
- Prescription medicine NCE registrations email list
- An introduction for external clinical evaluators
- Fixed combination prescription medicines
- Prescription medicine clinical units
- Stability testing for prescription medicines
- Guidance 7: Certified product details
- Guidance 11: Drug Master Files and Certificates of Suitability of a Monograph of the European Pharmacopoeia for drug substances
- Guidance 18: Impurities in drug substances and drug products
- Guidance 20: Radiopharmaceuticals
- Guidance 21: Medicines produced by genetic manipulation
- Guidance 23: Nonclinical studies
- Approval of form in which information sufficient for determination of applications in the eCTD format made under section 23 of the Therapeutic Goods Act 1989 for the registration of therapeutic goods must be delivered
- Antibiotic resistance guidance
- Access Generic Medicines work-sharing initiative
- Completing the biowaiver templates
- Completing the bioequivalence study information form
- Prescription medicines: applications under evaluation
- Post-approval changes to COVID-19 vaccines
- Cracking the code: Developing requirements for data matrix codes on medicines, 20 October 2021
- Mandatory requirements for an effective application
- Online presentation: Work-sharing, reliance, and other novel approaches to accelerating review, approvals, and access
Regulatory guidelines and standards
- Australian Regulatory Guidelines for Prescription Medicines (ARGPM)
- Print version of the regulatory guidelines for prescription medicines
- Compliance with ministerial and default standards
- Regulatory decisions and notices (prescription medicines)
- Updates to legislative instruments exempting monographs as standards
- EU and ICH guidelines not adopted in Australia
Australian Public Assessment Reports (AusPARs)
Biosimilars and biologicals
- Certified product details (CPD) - Biological prescription medicines
- Biosimilar medicines regulation
- Physical samples for batch release not required: a reminder for sponsors of biosimilars and biological medicines
New or extended uses
- Prescription medicines & biologicals: new registrations
- Prescription medicines: new or extended uses, or new combinations of registered medicines
- Prescription medicines: new or extended uses, or new combinations of registered medicines, 2020
- Prescription medicines: new or extended uses, or new combinations of registered medicines, 2019
- Prescription medicines: new or extended uses, or new combinations of registered medicines, 2018
- Prescription medicines: new or extended uses, or new combinations of registered medicines, 2017
- Prescription medicines: new or extended uses, or new combinations of registered medicines, 2016
Early scientific advice
- Early scientific advice
- Early scientific advice request form
- New Early Scientific Advice service to support medicine registrations
- Form for providing product information
- Reformatting Product Information: Frequently asked questions
- Guidance 8: Product information
- Changing sponsor details in Product Information (PI) and labels of prescription medicines
- Changing sponsor details in PI and labels
- Product information
- Certified product details (CPD) - Chemical prescription medicines
- Prescription medicine registration form
- Notification of proposal to submit supplementary data & submission of supplementary data
- Submission of an updated RMP
Section 14 consents for goods that do not comply with standards
- NewsThe Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open until 18 December 2022 for medicine sponsors to complete.
- NewsTell us your experience using of the beta Database of Adverse Event Notifications (DAEN) - medicines.
- Media releasesTGA's participation in INTERPOL's Operation Pangea, which tackles the trade of illicit and counterfeit therapeutic goods worldwide, led to intercepting more than $2 million of illegally imported products.