Recall procedure update
REPLACING the Uniform Recall Procedure for Therapeutic Goods (2004), the Therapeutic Goods Administration (TGA) has released an update of the document, following public consultation.
The TGA says the purpose of the new document, which takes effect 15 Jan 2018, is to “assist the sponsor to conduct recalls and non-recall actions using a standardised systematic procedure”.
Sponsors can follow the process to “respond efficiently and effectively to issues with a therapeutic good” where they believe the product may pose a risk to public health and safety.
Mandatory recalls ordered by the TGA will also need to follow the procedures outlined in the document, with civil and criminal penalties applying for noncompliance.
To access the new document visit tga.gov.au.