Continue through the procedure to determine if you need to conduct either

• a recall action (see Step 7)
• non-recall action (see Step 7).

In Step 1: Issues that may lead to recalls | Who identifies issues | Taking responsibility

Issues that may lead to recalls

A recall action is taken to resolve a deficiency (or potential deficiency) of a therapeutic good in relation to:

• safety
• efficacy (medicines and biologicals)
• performance (medical devices)
• presentation
• quality (for recall purposes, does not include the grade of materials or workmanship).

These deficiencies (or potential deficiencies) are due to non-compliance with specified standards, legislative requirements or manufacturing requirements applicable to the therapeutic good.

Who identifies issues

Issues requiring action can be identified through various means including:

• The manufacturer (through the implementation of the quality management system), who then contacts the sponsor.
• The Australian sponsor of the product (through adverse event reports or complaints).
• TGA (through our post-market monitoring and compliance activities); the TGA contacts the sponsor or other responsible entity.
• Other regulators who notify the TGA through international collaborative activities; the TGA contacts the sponsor or other responsible entity.
• Third party audits (e.g. by clients), inspections by other regulators and other avenues.

Taking responsibility

If you are a sponsor, you are responsible for conducting market action. Continue through this procedure.

If there is no legal sponsor (such as for illegally supplied therapeutic goods), then the manufacturer (if based in Australia), importer or supplier is responsible for the recall action and follows this procedure.

TGA can mandate a recall to protect the public from an unsafe good if the appropriate entity (sponsor, manufacturer, importer or supplier) does not undertake the recall action.

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

For most issues, the recall action needs to be agreed to by the TGA prior to being undertaken: continue to Step 3.

The TGA recognises that there are instances where immediate action is required that cannot await this agreement. This includes:

• immediate and significant threats
• radiopharmaceuticals
• biologicals

Immediate and significant threats

Contact the Australian Recall Coordinator if the issue poses an immediate and significant threat to one of the following:

• consumers
• a company
• employees
• the community as a whole.

Follow the advice of the Australian Recall Coordinator and then continue through the steps in the Uniform Recall Procedure for Therapeutic Goods.

Crisis involving tampering of therapeutic goods

You must notify the TGA of actual or potential tampering (section 42T of the Therapeutic Goods Act 1989).

Contact the Australian Recall Coordinator within 24 hours who will then notify the appropriate person.

Note: Civil and criminal penalties apply if you do not notify the TGA.

Radiopharmaceuticals

Contact customers immediately if there is an issue with a radiopharmaceutical.

Identify issue

There is an issue with radiopharmaceuticals if:

• the products do not comply with relevant specifications (some have such short half-lives they need to be distributed before all quality control test results are available)
• there are doubts as to the quality, safety, efficacy, performance or presentation.

Inform users

The distributing organisation (usually the manufacturer) needs to take immediate action when there is an issue with radiopharmaceuticals to prevent use by:

• informing customers and users by telephone, email or facsimile
• seeking acknowledgment that unused product has been quarantined.

Contact us

Contact the Australian Recall Coordinator and follow the remaining steps in the Uniform Recall Procedure for Therapeutic Goods.

Your written customer communication

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 department of nuclear medicine and pharmacy (for example, 'Director of Nuclear Medicine' and 'Chief Pharmacist').

Biologicals

Contact customers immediately if there is an issue with a biological.

Identify issue

There is an issue with biologicals if:

• the products do not comply with relevant specifications (some products are distributed before all quality control test results are available)
• there are doubts as to the quality, safety, efficacy or presentation.

Inform customers

Take immediate action to prevent use by:

• informing customers and users by telephone, email or facsimile
• seeking acknowledgment that:
  • unused product has been quarantined
  • the surgeon has been notified, in case the product has been implanted.

Contact us

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, you must provide the sponsor's customer letter to all known recipients of the affected products.

You should have already nominated at least two individuals who are authorised to act as recall contacts for your organisation and implement a recall action:

• If you have nominated current recall contacts, continue to Step 4.
• If you have not nominated any recall contacts, or the ones you have nominated are out of date, ask your TGA Business Services administrator to update your records now.
• If you do not have a TGA Business Services administrator (for example, you have illegally supplied therapeutic goods), continue to Step 4.

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 that the TGA can contact the individual out of hours.
7. Check that the contact is authorised to speak with the 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 the TGA.
8. Save the information by selecting 'Update details' (when editing a contact) or 'Create' (when adding a contact).

Obtain the information described below so that you can:

• complete the remaining steps in the Uniform Recall Procedure for Therapeutic Goods
• assure the TGA that any safety risks will be effectively mitigated.

In Step 4: Confidentiality | Information the TGA requires | Extra information

Confidentiality

Mark confidential information as 'confidential'.

TGA will manage any information that is commercially sensitive or private in nature according to the policy: Treatment of information provided to the TGA.

Information the TGA requires

The TGA requires the following information:

• details of the notifier
• description of the issue
• product report
• international regulatory action
• sample testing
• surgeon details.

Details of the notifier

Provide your name, telephone number and email address so the TGA can contact you if needed.

Description of the issue

Provide all relevant information about the issue:

• date issue first recognised
• photographs that help illustrate the issue (e.g. a broken medical device)
• how the issue occurred
• history of the incident, with specific dates and times when it occurred or was observed including any reported patient injuries
• failure rate
• potential failure mode due to the issue
• known issues or similar problems that have occurred in the past.

Product report

Provide the TGA with all available relevant information about the therapeutic goods involved. The sponsor may be the only one who knows some of this information, so it is important it is readily accessible in recall situations.

Product description

Product description consists of:

• product name
• ARTG number
• for a medicine:
  • dosage form
  • strength
  • pack size.
• for a medical device, a unique identifier such as:
  • catalogue number
  • model reference
  • part number
  • version number.

Manufacturing details

Manufacturing details of the affected products:

• lot number
• batch number
• serial number
• expiry date
• manufacturing dates
• donation number or tissue bank number.

Distribution details and stock status

Distribution details and stock status consist of:

• date released
• quantity of the batch released
• distribution dates and quantity to the Australian market
• where the product is in the distribution chain
• current undistributed stockholding
• quantity supplied to customers
• whether the product has been exported from Australia and, if so, to which countries.

International regulatory action

Provide the TGA with details of any regulatory action taken by other relevant regulators, such as the European Medicines Agency and the US Food and Drug Administration.

Sample testing

Provide results of tests and other investigations on suspect or other samples.

Surgeon details for implanted products

For implanted medical devices and biologicals, provide the TGA with contact details for the surgeons involved.

The TGA collects these contact details so that it can contact surgeons about recalls and actions related to recalls. This collection is authorised under Australian Privacy Principle 3.6(b), Schedule 1 of the Privacy Act 1988. For general information about privacy, go to Privacy.

Extra information

The TGA may need additional information if it needs to investigate further after the initial review. Examples of such information are:

• a review of all associated batch manufacturing, packaging, testing, release and distribution records for anomalies that may explain the suspected defect
• a full manufacturer corrective and preventive actions (CAPA) report
• examination and retesting of retained samples, if appropriate.

You are required to make sure that the risks have been analysed. You need to send the TGA a copy of the risk analysis in Step 9.

In Step 5: Reliability of your information | Medical device risk analysis | Biologicals, human blood and blood components investigation | Medicine risk analysis

Reliability of your information

Gather and assess the reliability of all available information about the potential hazard.

Medical device risk analysis

It is the medical device manufacturer's responsibility to identify any potential risks associated with an adverse event, product failure or complaint through use of an appropriate quality management system. Analysing risk is part of the risk management process, described in ISO 14971 Medical devices - application of risk management to medical devices.

Provide the TGA (in Step 9) with the risk analysis report produced by the manufacturer (often known as a health hazard evaluation or HHE report). You should have received this from the manufacturer when you were notified of the product defect.

The risk analysis report should include details of:

• the defect or deficiency
• potential failure mode
• failure rate
• how the defect was identified
• any reported patient injuries
• severity and probability of occurrence
• stock affected
• proposed market action by the manufacturer
• potential root causes and corrective actions (if available).

Ensure you are satisfied with the conclusions and recommendations before submitting this risk analysis, then continue to Step 6.

For more information, go to medical device risk analysis in the guidance on Roles in recalling therapeutic goods.

Biologicals, human blood and blood component investigation

Biologicals, human blood and blood components are manufactured according to the Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products.

This good manufacturing practice code specifies that the manufacturer will investigate adverse events and product complaints and will implement and maintain a written procedure for product recall. Provide the TGA (in Step 9) with the investigation report produced by the manufacturer.

Continue to Step 6.

Medicine risk analysis

The sponsor is responsible for analysing the risks with medicines.

When you analyse risk, consider both the potential hazards and the likelihood of these hazards. Consider all of the following:

1. whether any illness or injury has already occurred from use of the therapeutic product
2. whether any existing conditions could contribute to a clinical situation that could expose humans to a health hazard
3. the hazard to individual groups within the exposed population (such as children, the elderly, consumers having surgery or those who are immunocompromised)
4. the degree of seriousness of the health hazard to which the population will be exposed
5. the consequences (immediate or longer term) of occurrence of the hazard
6. alternative treatment options, including the hazard associated with providing no treatment where an alternative is not available
7. the potential harm to the user as a result of the issue
8. the likelihood of the issue occurring
9. results of tests and other investigations on suspect or other samples
10. the ability of the consumer, caregiver or health professional to discover or identify the issue prior to or during use
11. whether the therapeutic product is outside the manufacturer's specifications
12. the availability of an alternative therapeutic product, or the risk associated with not providing treatment if an alternative therapeutic product is not available.

Incorporate any a risk analysis or clinical investigation conducted by another relevant entity into your risk analysis and ensure you are satisfied with the conclusions and recommendations before submitting this risk analysis.

Continue to Step 6.

Once you have determined that you need to conduct a safety-related recall, inform the TGA promptly (see Step 9).

You can skip this step and go to Step 7 if you know the proposed action type, proposed classification and proposed level of recall action.

In Step 6: Types of recall actions | Non-recall actions | Risk based classification of recall actions | Level of recall action

Types of recall actions

Possible types of recall action are:

• recall
• product defect correction
• hazard alert
• product defect alert.

In some situations, you may wish to conduct a non-recall action.

Use your risk assessment to propose the action category type. If the TGA disagrees with your proposed action category, we will explain why and suggest an alternative.

Recall

Conduct a recall to remove products permanently from the market or from use when there are deficiencies or potential deficiencies in safety, quality, efficacy, performance or presentation.

Recalls include:

• Removal from supply or use of products with inherent design or manufacturing defects
• Requests to check and return products found to be defective sent to:
  • pharmacists
  • hospitals
  • pathology laboratories
  • fractionators
  • operating and research facilities
  • biomedical engineers
  • others.

Recalls do not include:

• removal of time-expired products
• removal of appropriate numbers of products for testing to determine whether there are deficiencies relating to quality, safety, efficacy, performance or presentation.

Product defect correction

A product defect correction is undertaken to correct a specific or potential deficiency.

In some instances, the product can continue to be used if there is robust mitigation in place until permanent correction has been implemented.

Product defect correction includes:

• the repair, modification, adjustment or re-labelling of therapeutic goods for reasons relating to deficiencies in the quality, safety, efficacy, performance or presentation
• corrections involving a product's expiry date
• updates or changes to any accessories, operating instructions or software.

The corrective action may take place at any agreed location, including:

• the user's premises (field correction)
• any other agreed location.

Product defect correction does not include removal of individual products for:

• repair in the event of an incidental malfunction or failure as a result of normal wear and tear or lack of good maintenance
• appropriate preventative maintenance
• modification due to technical improvements (that does not relate to quality, safety, efficacy, performance or presentation).

Hazard alert (implanted medical devices and biologicals)

A hazard alert is issued for an implanted good with a deficiency or potential deficiency relating to its safety, quality, performance or efficacy because implanted products (medical devices or biologicals) cannot be recalled.

Hazard alerts consist of:

• precautionary information for health professionals, including advice on:
  • situations to be aware of
  • potential complications
• advice about on-going management of affected patients.

A hazard alert may be issued in conjunction with a recall notice for affected products that have not been implanted.

Product defect alert

Discontinuation of treatment is sometimes riskier than continued use of the deficient product. This occurs for critical therapeutic products for which there is no alternative product or for which a recall action will result in interruption of patient treatment or a medicine shortage.

Product defect alerts:

• raise awareness of the concerns about safety, quality, efficacy or performance
• describe actions that clinicians or patients may take to mitigate risks due to product deficiencies.

A product defect alert may later be followed by a recall once unaffected or alternative products become available.

Non-recall actions

Not all issues require recall actions. You can conduct a non-recall action if:

• the therapeutic products meet all specifications and standards

and

• there are no deficiencies in safety, quality, efficacy, performance or presentation.

Before you undertake a non-recall action:

• fill out the form Notifying recall actions of therapeutic goods or email the TGA
• include a copy of your proposed communication for the TGA to review.

The TGA recommends you wait for its review before continuing with your non-recall action to avoid the need to undertake further market action.

Safety alert

Safety alerts are issued to provide information on safe use of products in certain situations where, although meeting all specifications and therapeutic indications, its use could present an unreasonable risk of harm if certain specified precautions are not followed.

A safety alert is generally for reiterating specific precautions or instructions regarding use of the products.

Send the TGA copies of the final signed version of the safety alert and we will:

• review the safety alert
• contact you with the outcome of our review
• publish in TGA's searchable database System for Australian Recall Actions (SARA)
• distribute the safety alert to:
  • state and territory recall coordinators and
  • appropriate parties in the recall notification.

Depending on the circumstances, the TGA may also:

• notify others, possibly alerting the public through our website
• ask you to provide progress reports in Step 12
• review the market action in Step 13.

Product notification

A product notification provides information about a product in a situation that is unlikely to involve significant adverse health consequences.

Quarantine

A quarantine action suspends further supply pending investigation of an issue or incident. The outcome of the investigation will determine whether further actions are required.

Product withdrawal

A product withdrawal is used to withdraw products for reasons that are not related to safety, quality, efficacy, performance or presentation. For example, removing a previous model when a new model has been released.

The risk based classification of recall actions

The TGA classifies recalls into three risk classes to convey the seriousness of the deficiency and the degree of risk involved.

Unlike the classes used for medical devices and biologicals, a Class I recall is the most serious. Class I and Class II are urgent, safety-related recalls. Class III recalls relate to the lowest risk cases and are not considered as urgent.

• Class I recall - a situation in which there is a reasonable probability that the use of, or exposure to, a deficient product will cause serious adverse health consequences or death.
• Class II recall - a situation in which use of, or exposure to, a deficient product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
• Class III recall - a situation in which use of, or exposure to, the deficient product is not likely to cause adverse health consequences.

For further information, see examples of Class I, Class II and Class III recalls.

Level of recall action

The action level (or depth) describes who will be notified of the recall action.

Determining the level

The TGA needs to agree on a number of aspects of the recall strategy, including the type, class and level of recall action (see Step 10). To determine the level consider the following:

• the channels by which the product has been distributed
• the extent to which distribution has taken place
• the potential harm to a user as a result of the issue
• the likelihood of the issue occurring
• the ability of the consumer, health professional or caregiver to identify the issue
• whether the product is outside the manufacturer's specifications
• the availability of an alternative product, or the risk associated with not providing treatment if an alternative product is not available:
  • Will this recall action result in a medicine shortage?

The four levels

There are four levels of recall action.

Sometimes, the scope can be narrowed to particular groups within the level. For example, for some retail level actions you do not need to contact supermarkets and health food stores.

Wholesale level

Wholesale level includes:

• medicine and device wholesalers, who are third parties holding product for distribution to retailers or other organisations
• state and territory purchasing authorities.

Hospital level

Hospital level includes:

• wholesale level
• hospitals
• nursing homes, hostels and other healthcare institutions
• clinical investigators and the institutions in which clinical investigations are performed
• hospital pharmacies, blood banks, pathology laboratories, operating facilities, fractionators, human tissue banks, other hospital departments
• ambulance services including the Royal Flying Doctor Service.

Retail level

Retail level includes:

• hospital and wholesale levels
• retail pharmacists
• dentists
• general practitioners
• other retail outlets such as supermarkets and health food stores.

Consumer level

Consumer level includes:

• retail, hospital and wholesale levels
• patients and other consumers.

Draft a recall action strategy, which you will submit to the TGA at Step 9.

You need the TGA's agreement with your recall strategy. You may negotiate with the TGA while you draft the strategy, or the TGA can liaise with you after you have submitted your strategy.

In Step 7: Objectives of a recall action | Overview of a recall strategy | Preparing your recall strategy

Objectives of a recall action

Your recall strategy needs to assure the TGA that the risks arising from the product deficiency will be effectively mitigated by:

• stopping the distribution, sale and use of the affected products as soon as possible
• effectively and efficiently removing from the market place or correcting any product that is potentially unsafe
• preventing further distribution of unsafe products
• informing the relevant authorities of the issue
• informing the product users of the issue
• analysis of root cause and implementation of CAPAs to prevent re-occurrence of issue.

Overview of a recall strategy

Your recall strategy should address:

• consumer, patient and health professional safety
• the quality of the product
• the nature of the deficiency in the product
• the number of complaints (including the number of known injuries or incidents)
• distribution networks
• exported products
• recovery procedures
• resources for field corrections and availability of alternative products
• the factors that may affect the duration of the recall action.

Preparing your recall strategy

Include in your recall strategy the following information:

• an explanation of the issue, including the potential hazard associated with the deficient product and your assessment of the risk posed by the product
• the proposed type, classification and level for the recall as described in Step 6
• the number of units supplied, relevant dates and their distribution within the supply chain including PBS supply for medicines if applicable
• details of any known injuries or incidents associated with the product
• details of the life cycle of the product
• information about the manner in which the recalled product will be collected and disposed, destroyed or rectified:
  • disposal must be in accordance with relevant Commonwealth, state and territory requirements
• strategy for exported products
• an expected close-out date
• action you have taken to identify and correct the cause of the hazard, including the outcome of any root cause analysis or the time period in which such analysis will occur
• contact details of:
  • the sponsor of the product
  • other entities in the supply chain to whom the recalling sponsor has supplied the product
  • international recipients of products.

You will also need a communication strategy, as described in Step 8.

Your first contact should be with the TGA, except for biologicals and radiopharmaceuticals.

You do not require a communication strategy if you are recalling human blood and blood components.

In Step 8: Communication strategy | Sponsor's customer letter | Paid advertisements | Media release

Communication strategy

The purpose of communicating information about a recall is to ensure that product-related injuries are prevented through the identification, removal and/or rectification of unsafe products.

The goal in communicating a product recall is to ensure that those within the supply chain comply with the recall notification.

Cooperation between all entities in the supply chain is essential for the recall action to be effective. You must notify in writing all affected parties within the supply chain.

Include in your communication strategy:

• a description of your intended audience:
  • within Australia
  • in other countries, if you have exported the product
• methods of communication
• a full draft copy of the proposed sponsor's customer letter, advertisements and any other written communications

Match the communication medium to the target audience. Direct your communication to the demographic particular for the recalled product and use an appropriate communication method.

For consumer level recall actions, include how you will manage contact from consumers about the recalled product, including any complaints.

The minimum requirement for formal written communication is a sponsor's customer letter sent to all known recipients of the affected products.

Sponsor's customer letter

The sponsor's customer letter is a factual statement of the reasons for the recall action, together with specific details that will allow easy identification of the deficient product.

See Sponsor's customer letter for recalling therapeutic goods for:

• instructions about what to include in the customer letter
• an example letter
• information on addressing customer letters.

In situations where public safety is under immediate threat and distribution of the affected product is limited:

• discuss the information and situation with the TGA
• if the TGA agrees, provide the information to be included in the letter by telephone and email, and then send the sponsor's customer letter to confirm the information.

Heading for customer communication

Use one of the following headings, as appropriate:

• for Class I or Class II recalls:
  • Urgent medicine recall
  • Urgent medical device recall
  • Urgent biologicals recall
  • Urgent product defect correction
  • Implant hazard alert
  • Urgent product defect alert
• for Class III recalls:
  • Medicine recall
  • Medical device recall
  • Biologicals recall
  • Product defect correction.

How to send the customer letter

Send your customer letter to all intended recipients within two working days of agreement by the Australian Recall Coordinator.

You may use email, mail, facsimile or document delivery systems. The TGA encourages the use of electronic systems, provided the system includes the ability to confirm receipt.

If your recall is Class I or Class II, the letter needs to be labelled as urgent:

• use a subject line for emails that starts with the word 'Urgent' followed by a description of the recall, such as 'Urgent product defect correction' or 'Urgent medicine recall', followed by the name of the deficient product; tag as 'high importance'
• use an envelope for mailed letters with bold red type in the top left corner as described in Sponsor's customer letter for recalling therapeutic goods.

Provide the TGA with a final, signed copy of the sponsor's customer letter at this time.

In some instances, sponsors could consider calling prior to sending the letter, and include this as part of their communications strategy.

Confirm receipt of the sponsor's customer letter

Follow up any recipients of the sponsor's customer letter who do not respond within the period of time specified in the customer letter. You need to ensure that all affected customers are aware of the recall action, and check that contact details are up-to-date.

Paid advertisements

For consumer level recalls, advertisements paid for by the sponsor are necessary unless complete and accurate distribution lists are available.

Paid advertisements are to:

• be inserted as soon as possible
• be published once in the daily newspapers of each state and territory in which distribution has possibly taken place a few days after the sponsor's customer letter has been sent:
  • as agreed with the TGA

  OR

  • as described by the delegate of the Secretary of the Department of Health in decisions relating to mandatory recalls
• be placed on one of the first ten pages of the newspaper
• have a minimum size of double column width and 10 cm depth and should be enclosed in a diagonally hatched border (see example advertisement).

For advice relevant to consumer recalls, see the ACCC publication Consumer product safety recall guidelines.

Text of advertisements

The title for the advertisements should be the same as the customer letters. The text is to be checked and agreed to by the TGA before publication.

You may need to tailor advertisements for specific groups of consumers. For example, it may be appropriate for the advertisement to be in two languages when the TGA knows that the products were sold to those from a specific non-English speaking background.

The text should contain the following information (see example advertisement):

• name of product
• Australian Register of Therapeutic Goods (ARTG) number (AUST L or AUST R) where this appears on the label of the product
• pack size
• dosage form or model
• batch, lot or serial number
• expiry date (where this appears on the label of the product)
• other details necessary to allow absolute identification
• reason for recall
• potential risks due to the deficiency
• a statement on the continued use or supply of the product, including any alternative products available
• the method of recovery, disposal or specifics of the proposed product correction
• an estimate of the likely time frame for:
  • the correction to be carried out
  • provision of replacement stock in the event you are unable to make an acceptable correction
  • availability of unaffected or alternate stock
• a contact telephone number (preferably toll free).

Media release

For Class I and Class II consumer level recalls, it may be necessary for you to issue a media release.

Develop and submit the text of a proposed media release. The TGA may need to seek expert advice in certain situations.

The media release should:

• contain sufficient detail to define the affected product uniquely
• give a clear explanation of the deficiency without causing unnecessary alarm
• describe the potential risks due to the deficiency
• state the appropriate actions to be taken by the consumer
• provide a telephone number (preferably toll-free) for consumers to obtain further information.

Inform the TGA promptly once you have determined that you need to conduct a recall (Step 6).

Submitting all necessary information

If you have not already done so, complete the online Notifying recall actions of therapeutic goods form or email the TGA with all the information that you currently have. For biologicals, human blood and blood components, complete the Human blood and tissues recall report form.

Submit the following to us:

• distribution details and stock status (Step 4)
• the risk analysis (Step 5)
• the proposed type, class and level of recall (Step 6)
• your recall strategy (Step 7)
• your communication strategy and draft communications (Step 8).

Once you have submitted this form you will receive a TGA recall reference number. Please use this reference number in all correspondence about this recall.

The TGA can help you determine the appropriate information to submit if you ask for help.

When you advise the TGA of a recall action, TGA will work with you on a case-by-case basis to address the issue as quickly as possible.

In Step 10: Analysing risk | Agreement to the recall strategy | Sending agreement letter | Notifying others

Analysing risk

The TGA will use all the information you provide to conduct its own independent assessment and decide on the appropriate recall type, class and level.

The TGA has access to experts who can help analyse the risks, especially when the nature or significance of the hazards involved is unclear.

Agreement to the recall strategy

The TGA will liaise with you on recall actions and will provide advice and assistance in relation to letters, advertisements and recall action strategies.

When the TGA reviews your recall strategy, TGA considers:

• the proposed timeline
• availability of alternative products and for critical products, whether future supply of stock might be affected.

If necessary, the TGA will seek advice from experts, such as clinical advisors and other technical experts.

The TGA needs to agree to:

• the type, class and level of recall action
• your recall strategy, including:
  • strategy close-out date
  • strategy for exported products
• your communication strategy
• text of all your associated written communications, such as:
  • sponsor customer letter
  • paid advertisements
  • media releases.

Sending agreement letter

The TGA will send you an agreement letter, which will:

• specify the approved details of the recall action
• provide instructions on contacting the ACCC, if your therapeutic goods are consumer goods
• contain templates for your reports.

Notifying others

The TGA will notify some organisations directly and will also publish information on its website.

System for Australian Recall Actions (SARA)

The TGA publishes information about all recall actions and safety alerts undertaken in Australia in the publicly searchable database System for Australian Recall Actions (SARA). This is published on or before the second working day following agreement to the recall strategy.

The TGA may publish the agreed sponsor's customer letters in SARA. The decision to publish a sponsor's customer letter in SARA is determined on a case-by-case basis.

TGA alerts

The TGA publishes alerts on its website. The TGA will liaise with you during the preparation of an alert and will provide you with a copy of the alert before it is published. These alerts provide information and advice to consumers and health professionals.

The decision to publish a TGA alert is determined on a case-by-case basis. Recall actions subject to a TGA web alert include, but are not limited to:

• implant hazard alerts
• consumer level recall actions
• recall actions for vaccines
• any recall action that may have wider implications for public health and safety.

The TGA's alerts contain information on the recall action, including sufficient detail to define the product uniquely. The TGA gives a clear explanation of the issue without causing unnecessary alarm and state the appropriate response by the consumer and health professional.

After publication, the TGA forwards the link to appropriate organisations and professional colleges for their attention.

The TGA recall and safety alert notice

For every recall and safety alert, the TGA develops a Notice, which contains information about:

• product identification
• nature of the issue
• assessment of user hazard
• distribution of product
• proposed action.

Some of the information (e.g., distribution details) provided with the TGA Recall Notice is confidential. As part of each Recall Notice, the recipients are advised that a Notice may contain commercially sensitive and confidential information, and safeguard this information and not to distribute it to third parties.

The TGA sends the TGA Recall Notice by email to:

• the relevant recall coordinators for each state and territory
• all parties listed in the Australian Recall Coordinator recall notification list.

For recall actions with wider health implications, the TGA will notify immediately:

• the Commonwealth Chief Medical Officer
• the appropriate state and territory Chief Health Officers.

The TGA will also share recall information with overseas regulatory agencies when appropriate.

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.

You will need to provide the TGA with recall progress reports at:

• 2 weeks (initial report)
• for human blood and blood components only: final report at 4 weeks
• 6 weeks (follow-up report)
• 3 months or at another agreed time (final report).

Produce the progress reports using the templates that the TGA provides you with your agreement letter. Submit the progress reports by email.

For human blood and blood components, provide a single report at 4 weeks.

Include in your reports:

• the TGA recall reference number (structured RC-201X-RN-XXXXX-X)
• effectiveness of recall
• whether the investigation changed the scope of the recall
• information about root cause of the deficiency and corrective and preventative action taken to prevent recurrence of the issue.

You are not required to repeat information that you have provided in a previous report, unless there is a change to that information.

The level of information in your reports should be sufficient for the TGA to analyse the effectiveness of the recall (Step 13). If the TGA is concerned about an aspect of your recall, it will follow this up with you.

Initial report (2 weeks)

You need to submit your initial report to the TGA at the agreed time, usually two weeks after recall implementation.

Include in your initial report information about:

• dates when parts of the recall strategy were implemented, such as when the sponsor's customer letter was sent
• descriptions of any major impediments, such as the recall or corrective actions not progressing according to agreed timelines
• implications of initial investigation findings for the scope of the recall action, such as whether additional units or products have been identified with the same defect
• for products exported from Australia, whether overseas suppliers have been informed of the recall action being undertaken in Australia.

Human blood and blood components report (4 weeks)

Recalls of blood and blood components have a 4-week close out. You need to complete a final report, but not a follow-up report.

Include details about the:

• fate of the components
• root cause investigation
• corrective and preventative actions implemented.

Follow-up report (6 weeks)

You need to submit your follow-up report to the TGA at the agreed time, usually six weeks after recall implementation.

Include in your follow-up report information about:

• percentage of customers that you contacted who have responded to your requested recall action:
  • have customers confirmed the amount of affected product held (including none)?
  • have they agreed to the recall or corrective action?
• percentage of customers who have returned or destroyed their affected units
• identification of customers with units requiring correction
• descriptions of any major impediments, such as the recall or corrective actions not progressing according to agreed timelines.

Final report (3 months or at another agreed time)

Submit your final report to the TGA at the agreed time, usually three months after recall implementation.

Include in your final report information about:

• percentage of stock that has been returned
• percentage of returned stock that has been destroyed or disposed: include a certificate of destruction if products are destroyed
• percentage of customers with units that have been corrected, or percentage of customers that have been supplied with the correction
• your root cause analysis of the deficiency that led to the recall action
• proposed CAPA to prevent the recurrence of the defect that led to the recall action.

Note: This information is part of the Consultation: Revised edition of the Uniform Recall Procedure for Therapeutic Goods

The TGA will examine your progress reports to:

• verify that:
  • all the agreed actions were completed and documentary evidence was provided
  • any discrepancies or inconsistencies are justified
  • evidence of the fate of the final product has been provided.
• determine whether the following are satisfactory:
  • implementation of the recall action
  • the investigation of the reason for the recall action and the root cause identification
  • CAPAs implemented to prevent or minimise the recurrence of the issue in the future
• assess the effectiveness of the recall action
• assess the ongoing compliance with regulatory requirements.

If the TGA is concerned about an aspect of the recall process, it will follow this up with you.

Outcomes of review

Possible outcomes of the TGA's review of the recall action include:

• Actions and information provided is satisfactory:
  • TGA issue a close-out report to you stating that the recall actions were satisfactory and no additional actions are required at this stage
  • the information submitted will be used to inform manufacturer inspections and for trending purposes in product reviews.
• Nature of the root cause or remedial action are not apparent:
  • TGA may request you submit additional information, including full CAPA reports, for review.
• Effectiveness of the recall action is not satisfactory:
  • TGA will follow-up with you to determine what additional actions are required to ensure the effectiveness of the recall action.
• Identification of a systemic or serious issue (at any stage of the recall process):
  • TGA may schedule an immediate inspection of the manufacturer
  • TGA may cancel or suspend or impose other requirements on the affected ARTG entries after further investigation.