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Uniform recall procedure for therapeutic goods, V2.2
Step 1. Immediate recalls
In circumstances where a sponsor becomes aware of a serious risk associated with a therapeutic good, immediate action may be required to protect the health and safety of consumers, a company, employees or the community as a whole.
Such circumstances may include:
- Immediate and significant threats and tampering
- Unsafe or defective radiopharmaceuticals
- Unsafe or defective biologicals, human blood and blood components
For all other recalls and non-recall actions go to Step 2 Obtaining distribution details and stock.
Immediate and significant threats and tampering
Contact the Australian Recall Coordinator if either:
- The issue with the goods poses an immediate and significant threat to consumers, a company, employees or the community as a whole.
- There is a crisis involving tampering of therapeutic goods (within 24hrs).
Tampering of therapeutic goods
Any person who supplies, manufactures or sponsors therapeutic goods must notify TGA of actual or potential tampering (section 42T of the Act):
- Address your notification to the Principal Medical Adviser, c/- the Australian Recall Coordinator
- Email the notification to email@example.com.
Civil and criminal penalties apply if you do not notify TGA.
Tampering occurs when both:
- The goods are interfered with in a way that affects, or could affect, their quality, safety or efficacy.
- The interference has the potential to cause, or is done for the purpose of causing, injury or harm to any person.
Crisis management guidelines
The Crisis Management Guidelines for the management of actual, potential or threatened tampering of medicines, complementary healthcare products and medical devices include the crisis management structure, your communications and recall strategy.
These guidelines were developed by the Australian Self Medication Industry (ASMI) in consultation with:
- Medicines Australia (MA)
- Complementary Medicines Australia (CMA)
- the Medical Technology Association of Australia (MTAA)
- Consumers Health Forum
- Therapeutic Goods Administration
- State and Territory health departments
- Australian Federal Police
- State and Territory police departments.
We urge you to implement the Crisis Management Guidelines as quickly as possible and ensure that appropriate personnel are trained in their operation.
To obtain a copy of the Crisis Management Guidelines:
- For sponsors who are members of the following industry associations - ASMI, MA, CMA, MTAA and the Generic and Biosimilar Medicines Association (GBMA) - refer to the 'members-only' page(s) of your association's website.
- For sponsors who are not members of any of the above industry associations, ASMI or the Australian Recall Coordinator can provide a copy.
Supplementary material is also available: Product contamination & extortion - a protocol for the therapeutic goods industry.
Contact customers immediately by telephone, email or facsimile to prevent use if:
- the goods do not comply with relevant specifications (some have such short half-lives that they need to be distributed before all quality control test results are available)
- there are doubts as to the quality, safety, efficacy or presentation of the goods.
Seek customers' acknowledgment that they have quarantined unused goods.
Contact the Australian Recall Coordinator and follow the remaining steps in this procedure.
Following the TGA's agreement to the recall action, you must:
- provide the sponsor's customer letter to all known recipients of the affected products.
- send your letter to the head of each relevant hospital department of nuclear medicine and pharmacy (for example, 'Director of Nuclear Medicine' and 'Chief Pharmacist').
Biologicals, human blood and blood components
There is an issue with biologicals or human blood and blood components if either:
- The goods do not comply with relevant specifications.
- There are doubts as to the quality, safety, efficacy or presentation of the goods.
For biologicals: contact customers immediately by telephone, email or facsimile to prevent use.
For blood and blood components: contact the Australian Recall Coordinator by telephone to obtain a TGA recalls reference number before contacting customers.
Seek customers' acknowledgment that they have:
- quarantined unused goods
- notified the surgeon (for implanted biologicals)
- notified the clinician for infused blood components based on assessment by the Blood Service.
Complete the Human blood and tissues recall report form and send it to the TGA.
Contact the Australian Recall Coordinator and follow the remaining steps in the Uniform Recall Procedure for Therapeutic Goods.
Following the TGA's agreement of the recall action, provide the sponsor's customer letter to all known recipients of the affected products.