You may be required to comply with this guideline if you are a sponsor of medicines included on the Australian Register of Therapeutic Goods (ARTG).
Pharmacovigilance involves the science and activity related to detecting, assessing, understanding and preventing adverse effects and other medicine-related problems.
The guideline sets out the pharmacovigilance responsibilities of the sponsor and includes:
- mandatory reporting requirements
- recommendations on pharmacovigilance
- legal basis for pharmacovigilance requirements.
Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.