Once the TGA has agreed to your communication and recall strategies, you need to implement them.

In Step 11: Notify the ACCC | Retrieve the affected products | Root cause analysis

Notify the ACCC

Report the recall to the Australian Competition and Consumer Commission (ACCC) if the recall is of consumer therapeutic goods. The TGA will provide you with instructions about this in its agreement letter.

Retrieve the affected products

If agreed in the recall strategy, make arrangements for the retrieval of the product:

• establish collection points across the distribution network
• notify relevant parties, including other entities in the supply chain and consumers of the method of retrieval of the recalled product
• arrange for the disposal of the returned product:
  • you may arrange for the returned product to be held and kept separate until it can be rectified or safely destroyed.

You may use company representatives (medical detailers and sales representatives) to recover stock that is subject to recall, providing that this is legal. You need to observe relevant state, territory and Commonwealth regulations in relation to unauthorised possession of certain stock (for example, medicines of addiction and restricted substances).

In the case of a mandatory recall, the TGA may require you to take specified steps for the retrieval of therapeutic goods.

Undertake root cause analysis

Root cause analysis of the issues needs to be undertaken in parallel with the recall action process. This is usually done by the manufacturer.

You will need to provide the root cause analysis to the TGA in the final progress report (Step 13).

This will assist the TGA in assessing the ongoing compliance with regulatory requirements required under the life-cycle approach described in the therapeutic goods regulatory framework.