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


You may be required to comply with this guideline if you intend to manufacture medicines and medical drugs for use on humans and applies to all sponsors who have medicines registered or listed on the Australian Register of Therapeutic Goods (ARTG). You must meet the reporting responsibilities for all the medicines you have listed or registered on ARTG,

Each sponsor of registered medicines must ensure that it has an appropriate system of pharmacovigilance in place in order to assure responsibility and liability for its products on the market and to ensure that appropriate action can be taken, when necessary. This guidance outlines mandatory reporting requirements and suggests recommendations on pharmacovilgance practice.

Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.

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.

Act(s) name

Therapeutic Goods Act 1989 AG

Regulation(s) name

Therapeutic Goods Regulations 1990 AG

Administering agency

Department of Health

Therapeutic Goods Administration

Contact details

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

Therapeutic Goods Administration

Department of Health

Mailing address: PO BOX 100
Woden, Australian Capital Territory 2606
Mailing address: 136 Narrabundah Lane
Symonston, Australian Capital Territory 2609
Phone: 1800 446 443