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Uniform recall procedure for therapeutic goods (URPTG)
V2.1, February 2019
Important notice to all stakeholders
A new version of the Uniform Recall Procedure for Therapeutic Goods (URPTG) (V2.1, February 2019) has been implemented, with effect from Monday, 11 February 2019.
This version updates V2.0 to clarify the requirements relating to 'quarantine' and to provide greater flexibility for sponsors when communicating information about consumer level recalls. The former version (V2.0) has been archived. Sponsors wishing to initiate a market action in accordance with the URPTG must now use the new version.
To make an immediate recall...
- Go to Step 1 of the recall procedure.
- Immediate recalls apply to:
- Immediate and significant threats
- Actual (or potential) product tampering
- Human blood or blood component
For all other recalls and non-recall actions, go to Step 2 of the recall procedure.
This guidance on the Uniform Recall Procedure for Therapeutic Goods (URPTG) provides a consistent approach for undertaking recall and non-recall actions of therapeutic goods supplied, imported into or exported from Australia.
The purpose of the URPTG is to assist the sponsors of therapeutic goods to conduct recalls and non-recall actions using a standardised systematic procedure.
It enables sponsors to respond efficiently and effectively to issues with a therapeutic good that has or may pose a risk to public health and safety.
Requirements of this procedure can also be applicable when the TGA orders an appropriate responsible entity to conduct a mandatory recall. Civil and criminal penalties apply if you do not comply with a mandatory recall.
|Version||Description of change||Author||Effective date|
|V1.0||Publication for consultation||Therapeutic Goods Administration||27 October 2015|
This version of the URPTG consists of:
Recalls and Case Management Section
Regulatory Guidance Team
Publication date: 3 October 2017
From publication date, a familiarisation period applies until 15 January 2018
Implementation date: 15 January 2018
|V2.1||This version of the URPTG includes clarifying amendments in relation to the new (January 2018) requirements for 'quarantine' actions and introduces a more flexible approach for 'consumer recall notices' required as part of conducting consumer level recalls. (These 'notices' were formerly referred to as 'recall advertisements').||Recalls Section||February 2019|
Templates to help you with your communications:
- envelopes for safety-related recalls
- example consumer recall notice
- example sponsor customer's letter
- example customer acknowledgement form
As part of an extensive stakeholder consultation process, the URPTG was reviewed and updated to ensure it is consistent with current regulatory 'best practice'. Following this process, Version 2.0 was published in October 2017 and took effect on Monday, 15 January 2018.
In consultation with key stakeholders, provisions of the URPTG will be reviewed on a regular basis to ensure currency of the guidance provided.
Following further stakeholder consultation throughout 2018, Version 2.1 of the URPTG will be implemented and take effect on Monday 11 February 2019.
While the fundamentals for undertaking a recall or non-recall action remain largely the same, in response to the consultation process, the new URPTG –
- introduces two new types of recall actions – 'product defect correction' and 'product defect alert'
- removes the term - 'recall for product correction'
- introduces a new type of non-recall action – 'quarantine'
- removes the non-recall action known as 'recovery'
- provides a web friendly format and provides step-by-step instructions for conducting recalls
- clarifies existing processes and clearly delineates the roles and responsibilities of the different parties who can be involved in recalls
- introduces probability aspects as part of the recall classification process
- introduces some new terminology; and
- provides information about the legislative powers for mandating recalls.
More detailed explanations of these major changes to the URPTG are described below.
Following implementation of V2.0, it became evident that certain specific provisions required some further clarification. V2.1 includes more detailed guidance on how the TGA will administer the new non-recall action listed in the URPTG known as 'quarantine'. This version also clarifies the TGA's expectations with regard to the publication of 'consumer recall notices' for consumer level recalls and provides a more flexible and equitable approach for doing so.
The URPTG now defines four (4) different types of recall actions. A recall action is conducted to remove therapeutic goods permanently from the market or from use when there are deficiencies or potential deficiencies in safety, quality, efficacy, performance or presentation. The four types of recall action are:
- product defect correction (replaces 'recall for product correction')
- hazard alert
- product defect alert.
Yes. The new terms are 'product defect correction' and 'product defect alert'; and these are defined below.
Minor amendments have also been made to the terms, 'recall' and 'hazard alert', but the overall meanings remain largely unchanged.
No, not from 15 January 2018. The term 'recall for product correction' was replaced by the new term, 'product defect correction'.
The URPTG still defines four (4) different types of non-recall actions which can be conducted if the therapeutic goods meet all specifications and standards; and there are no deficiencies in safety, quality, efficacy, performance or presentation of the goods. The four types of non-recall action are:
- safety alert
- product notification
- product withdrawal.
Yes. The new term is 'quarantine' which has replaced 'recovery' and is defined below.
Minor amendments have been made to the terms, 'safety alert', 'product notification' and 'product withdrawal', but the overall meanings remain largely unchanged.
The URPTG also introduces the following new definitions:
'CAPA' means corrective and preventative action.
'Consumer goods' means goods intended for personal, domestic or household use.
'Consumer recall notice' replaces the term 'advertisement' or 'recall advertisement' as it better reflects the new, flexible approach for informing consumers about consumer level recalls.
'Failure mode' in relation to the recall of therapeutic goods, means how the failure will be presented.
'Failure rate' in relation to the recall of therapeutic goods, means the frequency with which the failure occurs for the affected stock.
'Product defect alert' means a type of recall action that raises awareness of concerns about safety, quality, efficacy or performance when discontinuation of treatment is considered riskier than continued use of the deficient product.
'Product defect correction' replaces the term, 'recall for product correction' but retains a comparable meaning, i.e.
"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 a 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."
'Quarantine' means a type of non-recall action in which the sponsor suspends further supply pending investigation of an issue or incident. The outcome of the investigation will determine further actions. A recall may occur after quarantine.
The new URPTG includes the following new features –
- it is now presented in a 'web friendly' format which is easy to navigate
- it now provides step-by-step instructions and supporting information for sponsors (and any other responsible entities) to follow when conducting a recall
- it now clearly delineates the roles and responsibilities of the different parties who can be involved in a recall, including sponsors, manufacturers, wholesalers and distributors, exporters, health professionals, consumers, the TGA, state and territory recall coordinators and the Australian Competition and Consumer Commission (ACCC)
- it provides greater clarification on the requirements for medical devices (including in-vitro diagnostic goods (IVDs), and
- also includes a refinement of the information required to assess a recall action.
Yes, however, the definitions have been slightly changed to introduce probability aspects which will assist with assigning the appropriate risk classification, where 'risk' = 'severity' x 'probability'.
No. Recalls will still be classified as, either –
- wholesale level
- hospital level
- retail level; or
- consumer level.
No. The URPTG is not underpinned by the therapeutic goods legislation or established as a legislative instrument. It is a long-standing guidance document and this latest version is now published following extensive public consultation.
If a responsible entity chooses not to follow the URPTG process, the Therapeutic Goods Act 1989 does provide powers for the Secretary to mandate the public notification and recall of therapeutic goods.
The Secretary may mandate recall action in relation to therapeutic goods for a range of reasons, including where the goods are unsafe, are of defective quality, for medical devices that do not comply with the essential principles, where the goods have been cancelled from the ARTG and so on.
In any case, requirements of the URPTG can be made applicable when the Secretary orders a responsible entity to conduct a mandatory recall.
Yes. The Act includes criminal offence and civil penalty provisions ranging up to 50,000 penalty units for non-compliance with requirements imposed to conduct a mandatory recall.
Follow the URPTG. We strongly encourage sponsors to continue working cooperatively with us in accordance with the URPTG in order to remove defective or unsafe goods from the market. This is the time proven, most optimal way to proceed in the interests of ensuring public health and safety.