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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.
If you need further guidance, consider whether you need a pre-submission meeting. See Pre-submission meetings with TGA.
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PageInformation on prescription medicine application pathways.
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PagePre-submission planning is the first phase of the prescription medicines registration process.
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PageFind out how to submit your prescription medicine application and dossier.
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PageData the TGA evaluates before a prescription medicine can be registered in the Australian Register of Therapeutic Goods (ARTG).
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PageSponsors have ongoing responsibilities when a prescription medicine is registered in the Australian Register of Therapeutic Goods (ARTG).
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PageVary your Australian Register of Therapeutic Goods (ARTG) entry for prescription medicines.
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PageWe welcome applications to register new generics of medicines included in the Australian Register of Therapeutic Goods (ARTG) that are in long-term shortage.
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PageInformation 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
- Submitting Certified Product Details (CPD) for biological prescription medicines
- Submitting Drug Master Files and certificates of suitability for drug substances
- Complying with requirements relating to impurities in prescription medicines
- Radiopharmaceuticals
- Understanding requirements for prescription medicines produced by genetic manipulation
- 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)
- 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 and 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
- Understanding requirements for providing a Product Information (PI) document
- Changing sponsor details in Product Information (PI) and labels of prescription medicines
- Changing sponsor details in PI and labels
- Product Information
- PI/CMI search facility
- Product Information
Forms
- Certified product details (CPD) - Chemical prescription medicines
- Prescription medicine registration form
- Notification of proposal to submit supplementary data and submission of supplementary data
- Submission of an updated RMP
- Notification of commencement/cessation of supply
Section 14 consents for goods that do not comply with standards
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