You are here
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.
- PageApplication process for prescription medicinesInformation on prescription medicine application pathways.
- PageSubmit your application and dossierFind out how to submit your prescription medicine application and dossier.
- PageTGA evaluationData the TGA evaluates before a prescription medicine can be registered in the Australian Register of Therapeutic Goods (ARTG).
- PageYour ongoing responsibilitiesSponsors have ongoing responsibilities when a prescription medicine is registered in the Australian Register of Therapeutic Goods (ARTG).
- PageVary your ARTG entry for a prescription medicineVary your Australian Register of Therapeutic Goods (ARTG) entry for prescription medicines.
- PageReforms to the regulation of prescription medicinesInformation 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
Main navigation
Resources
- GuidanceNotifications process: requests to vary registered medicines where quality, safety and efficacy are not affectedOutlines types of variations that have been determined to pose a very low risk.
- FormsSection 19A application form to import and supply substitute medicinesApply to import and supply substitute medicines under section 19A
- GuidanceMedicine shortages: Information for sponsors (suppliers)We have updated guidance on how to report medicine shortages to make the process clearer and easier to understand
Latest alerts
- Product recallsEvolutTM PRO+34mm Transcatheter Aortic Valve (TAV)Medtronic Australasia is informing customers about the serious risk of valve infolding for EvolutePRO+ 34mm Transcatheter Aortic Valve (TAV), item code - EVPROPLUS-34US.
- Safety alertsPholcodineThe TGA has decided to cancel the registration of pholcodine-containing medicines and is recalling them from pharmacies.
- Medicine shortage alertsNationwide shortage of certain antibiotics - updateThe shortages list of antibiotics has been updated.
Latest articles
- Media releasesQueensland individual fined nearly $16,000 after allegedly importing unregistered nicotine vaping productsIt is alleged that the individual attempted to import six different types of nicotine vaping products (prescription medicines). The unapproved nicotine vaping products were intercepted by the Australian Border Force and have been seized and will be destroyed under advice from the TGA.
- NoticesGMP Clearance: Extension processing timesDelays in processing timeframes of applications to extend GMP Clearances.
- Safety updatesImportant safety information for Janus kinase (JAK) inhibitorsNew warnings for baricitinib, tofacitinib and upadacitinib follow a TGA review of a randomised safety trial called the ORAL Surveillance Study.
Latest publications
- PublicationsPharmacovigilance Inspection Program metrics report: Jan - Dec 2021The TGA Pharmacovigilance Inspection Program (PVIP) metrics report for 2021 is now available.
- PublicationsManufacturing principles for medicinal productsPIC/S Guide to Good Manufacturing Practice for Medicinal Products
- PublicationsPharmacovigilance Inspection Program metrics report: Jan - Dec 2020The PVIP aims to strengthen and broaden the TGA's post-market monitoring activities and protect public health
Latest consultations
- Closed onConsultationConsultation: Adoption of International Scientific Guidelines in Australia - closed November 2022The TGA is seeking feedback on whether certain international scientific guidelines should be adopted.
- Closed onConsultationConsultation: Product Information as a package insert in boxed injectablesPublic consultation on the Product Information (PI) as a package insert in boxed injectable products.
- Closed onConsultationConsultation on the new Therapeutic Goods Order 106 - Data matrix codes and serialisation of medicinesThe 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.