What Australian Register of Therapeutic Goods (ARTG) - Requirements for AUST R and AUST L Medicine Registration: Product Information Approval, Risk Management Plans, Classification, Quality, Safety and Efficacy Evaluation, TGA Audit System and Post-Market Review requires
This regulation governs the inclusion of medicines in the Australian Register of Therapeutic Goods (ARTG) under AUST R (registered) or AUST L (listed) pathways, requiring sponsors to demonstrate quality, safety, and efficacy, comply with classification rules (prescription vs OTC), submit approved Product Information (PI), implement Risk Management Plans (RMPs) where applicable, and adhere to TGA audit and post-market surveillance requirements under the Therapeutic Goods Act 1989, Section 23.
Pillar: Pharmaceuticals & Life Sciences · Authority: Therapeutic Goods Administration (TGA), Australian Government Department of Health · Version: 1.0.0 · Last updated:
Primary source: https://www.tga.gov.au/resources/resource/guidance/australian-register-therapeutic-goods-artg
SHA-256 integrity: 2468708244c02f96ae3b26daf20db18c8028be43e453bfbcd2eb9a30fbf5f86d
Primary Citations — 5 traced to source
- Therapeutic Goods Act 1989, https://www.legislation.gov.au/Act/C1989A0080, Section 23, 1989
- Australian Register of Therapeutic Goods (ARTG), https://www.tga.gov.au/resources/resource/guidance/australian-register-therapeutic-goods-artg, Section 3.1 - Registration and Listing, 2023
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