DRAFT: Uniform Recall Procedure for Therapeutic Goods
Consultation document
Step 4 - Obtaining information
Note: This information is part of the Consultation: Revised edition of the Uniform Recall Procedure for Therapeutic Goods
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.
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.
Please do not tell us the names of individual patients.
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.
Please do not give us the names of individual patients.
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.