Australian Requirements and Recommendations for Pharmacovigilance Responsibilities of Sponsors of Medicines - Australian Government


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.

Service type

Code of Practice

A code of practice is a set of rules which details how people in a certain industry should behave. A code of practice can be defined as a result of legislation or by industry regulators and bodies.

Eligibility requirements

Please consult the Contact Officer for more information regarding eligibility requirements.

Act(s) name

Therapeutic Goods Act 1989 Australian Government

Regulation(s) name

Therapeutic Goods Regulations 1990 Australian Government

Administering agency

Department of Health and Aged Care

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.