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
- scheduling
- concurrent applications
- mandatory requirements for an effective application.
- Application process for prescription medicinesPageInformation on prescription medicine application pathways.
- Submit your application and dossierPageFind out how to submit your prescription medicine application and dossier.
- TGA evaluationPageData the TGA evaluates before a prescription medicine can be registered in the Australian Register of Therapeutic Goods (ARTG).
- Your ongoing responsibilitiesPageSponsors have ongoing responsibilities when a prescription medicine is registered in the Australian Register of Therapeutic Goods (ARTG).
- Vary your ARTG entry for a prescription medicinePageVary your Australian Register of Therapeutic Goods (ARTG) entry for prescription medicines.
- Registration of prescription medicines to manage shortagesPageThe TGA welcomes applications to register new generics of medicines included in the Australian Register of Therapeutic Goods (ARTG) that are in long-term shortage.
- Reforms to the regulation of prescription medicinesPageInformation about reforms to the regulation of prescription medicines.
More information
- 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
Application guidance
- 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
Trade names
Product information
- 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
Forms
- 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
Topics
Resources
- Serious Scarcity Substitution Instruments (SSSIs)GuidanceSerious Scarcity Substitution Instruments (SSSIs) allow community pharmacists to substitute specific medicines without prior approval from the prescriber so long as the permitted circumstances within the SSSI are met.
- Seasonal influenza vaccines - quality moduleGuidanceExplanatory guide on the quality modules to be submitted for influenza vaccine registration, for manufacturers and sponsors.
- Notifications process: requests to vary registered medicines where quality, safety and efficacy are not affectedGuidanceOutlines types of variations that have been determined to pose a very low risk.
Latest alerts
- Tenecteplase (Metalyse) shortage updateMedicine shortage alertsWe have been notified that the shortage of tenecteplase (Metalyse) will continue until 31 December 2024.
- Medicines containing turmeric or curcumin - risk of liver injurySafety alertsThe TGA has received reports of liver problems experienced by consumers taking medicines containing turmeric or curcumin.
- Change to supply of oral cefalexinMedicine shortage alertsRead about how the shortage of oral cefalexin medicines, that started in December 2022, no longer applies to capsules.
Latest articles
- COVID-19 vaccine: JanssenNewsOn 28 August 2023, Janssen-Cilag Pty Ltd voluntarily cancelled COVID-19 VACCINE JANSSEN from the Australian Register of Therapeutic Goods (ARTG).
- TGA seizes 40,000 vapes as part of multi-agency operation in QueenslandMedia releasesOn 29 August 2023, the TGA executed multiple warrants on storage units and residences in Brisbane and seized over 40,000 vaping products with an estimated street value of over $1.2 million
- Product Information inserts are no longer required for injectable medicines administered by health professionalsNewsFind out how Product Information inserts won’t be required in the packaging of injectable medicines, given by health professionals, starting from September 2023.
Latest publications
- ACV meeting statement, Meeting 42, 12 April 2023Meeting statementsAdvisory Committee on Vaccines meeting statement
- ACV meeting statement, Meeting 41, 9 February 2023Meeting statementsAdvisory Committee on Vaccines meeting statement
- Pharmacovigilance Inspection Program metrics report: Jan - Dec 2021PublicationsThe TGA Pharmacovigilance Inspection Program (PVIP) metrics report for 2021 is now available.
Latest consultations
- Consultation: Adoption of International Scientific Guidelines in Australia - closed November 2022Closed onConsultationThe TGA is seeking feedback on whether certain international scientific guidelines should be adopted.
- Consultation: Product Information as a package insert in boxed injectablesClosed onConsultationPublic consultation on the Product Information (PI) as a package insert in boxed injectable products.
- Consultation on the new Therapeutic Goods Order 106 - Data matrix codes and serialisation of medicinesClosed onConsultationThe Therapeutic Goods Administration (TGA) is seeking feedback on proposed requirements for serialisation and the use of data matrix codes on the labels of certain medicines in the Australian supply chain.