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.