Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines
Version 1.3
4 June 2014
Annex 4: Glossary
| ACPM | Advisory Committee on Prescription Medicines |
|---|---|
| AE | Adverse event |
| AR | Adverse reaction |
| ARTG | Australian Register of Therapeutic Goods |
| CIOMS | Council for International Organizations of Medical Sciences |
| MedDRA | Medical Dictionary for Regulatory Activities |
| OMA | Office of Medicines Authorisation |
| OPR | Office of Product Review |
| PI | Product information |
| PSUR | Periodic Safety Update Report |
| SAS | Special Access Scheme |
| TGA | Therapeutic Goods Administration |
| The Act | The Therapeutic Goods Act 1989 |
| The Regulations | The Therapeutic Goods Regulations 1990 |