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Australian Regulatory Guidelines for Prescription Medicines (ARGPM)
The ARGPM provides guidance to assist applicants and sponsors to register new prescription medicines or vary existing registrations in Australia.
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- FormsSponsors can use this form to apply for an additional trade name for a registered prescription medicine, under section 23 of the Therapeutic Goods Act 1989.
- FormsUse this form for Category 1 and Comparable Overseas Regulator (COR) report-based prescription medicines applications, or variations.
- Therapeutic goods and use of human embryos or human embryonic stem cells or material derived therefromFormsFind out what process to follow if a product is manufactured using a human embryo or a human embryonic stem cell, or any material sourced from such an embryo or stem cell.
- GuidanceThis guidance describes the information included in an Australian Public Assessment Report (AusPAR) and the circumstances when we publish them.