Announcement date
23/09/2022
Link to announcement
https://www.legislation.gov.au/Details/F2022L01252
Problem being addressed
Legislation set to sunset and be remade.
Proposal
The Department of Health and Aged Care has certified that the Therapeutic Goods Information (Database of Adverse Event Notifications) Specification 2012 is operating effectively and efficiently and has been remade. This self-assessment was informed by two targeted consultations with stakeholders including consumer, medicine sponsor and health professional representative groups. No concerns or issues with the operation of the Regulation were raised in consultation. Accordingly, the instrument has been remade with minor amendments to clarify that adverse events associated with biological therapies as well as medicines may be published in the Database of Adverse Event Notifications (DAEN) for medicines.
Assessed RIS outcome
Certification Letter
Regulatory burden
NIL