Sponsors and recalling goods

If you are considering recalling a therapeutic good, follow the recall procedure.

As a sponsor of a therapeutic good, you have ongoing responsibilities to ensure you are prepared for a recall and able to respond appropriately to complaints and problem reports.

On this page: Responsibility for recalling goods | Your recall procedure | Communicating with other interested parties | Keeping details up-to-date | Distribution records | Analysing risk | Communicating with your distributors

Responsibility for recalling goods

The sponsor is responsible for conducting a recall, but can authorise third parties.

A TGA delegate for the Secretary of the Department of Health can mandate a recall to protect the public from an unsafe good in accordance with the Act if the manufacturer or sponsor does not undertake the recall.

Civil and criminal penalties apply if you do not comply with a mandatory recall.

Your recall procedure

Your written recall procedure should take into account and include:

• Immediate recall (Step 1): it is essential that you follow Step 1 - in most cases, this involves contacting the Australian Recall Coordinator straight away.
• A step for noting our agreement to your recall and communication strategies (Step 8).
• The people in your organisation who will be involved in a recall
• How to access current contact details for:
  • TGA
  • businesses and organisations to contact
  • hospitals and other healthcare facilities to contact
  • bodies representing health professionals
  • general retail outlets that may supply your products
  • state and territory recall coordinators
  • funding bodies
• The actions to take (listed in chronological order), including those described in this procedure
• How you obtain technical details for the recall and any organisational contact details
• How you obtain distribution records (including to any export customers)
• your procedure for documenting the organisations contacted and their responses
• possible arrangements for:
  • returned goods
  • quarantine facilities
  • disposal or modification of the affected goods
  • replacement of the affected stock
  • reimbursing direct costs incurred by those acting on the instructions in your sponsor's customer letter
• report on progress in Step 10 of the recall procedure.

Communicating with other interested parties

It is your responsibility to communicate with interested parties not directly involved in the recall (e.g. funding bodies).

Keeping details up-to-date

Have arrangements in place so that your TGA Business Services administrator keeps your recall coordinator details in the system up-to-date.

If you do not have a nominated recall contact person, ask your TGA Business Services administrator to update your records.

How your administrator nominates recall contacts

The steps for the 'administrator' to nominate recall contacts:

1. Log in to TGA Business Services.
2. View my organisation.
3. View all contacts.
4. Edit a contact or add new contact.
5. Under 'Organisation contact role' select 'RC - Recalls Contact'.
6. Enter a mobile number so we can contact the individual out of hours.
7. Check that the contact is authorised to speak with TGA:
   1. 'Contact authorisation' appears directly under 'Organisation contact role'
   2. for your own entry, 'Account settings' will show 'Additional information' if you are authorised to speak to us.
8. Save by selecting either:
   1. 'Update details' (when editing a contact)
   2. 'Create' (when adding a contact).

Distribution records

Keep sufficient records so you can recall any batch of goods from the distribution chain (a condition of entry on the ARTG).

All distribution records should be easy to follow and readily available to us if we ask.

We rely on you for certain details (such as batch size, distribution chains and quantities distributed) that are important for developing a recall strategy.

Analysing risk

The sponsor (when also the manufacturer) is responsible for analysing the risks with medicines.

If the sponsor is not also the manufacturer, the sponsor may conduct the risk assessment in conjunction with the manufacturer.

Communicating with your distributors

Make your wholesalers and distributors aware of their role in the recall of therapeutic goods. Cooperation from wholesalers and distributors is often essential for an effective recall.

Every wholesaler should have a procedure describing how they will conduct a recall if you request them to do so. Wholesalers of scheduled medicines should follow the Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8.