Author: Jenny Lin / Senior Manager, Medical Devices / IVD, Australia
In response to challenges sponsors have faced in preparing detailed patient information leaflets (PILs) and patient implant cards (PICs) in time for a 1 December 2021 deadline, the Therapeutics Goods Administration (TGA) has released an update that gives companies some leeway in meeting these requirements.
Initially, all implantable devices (other than those exempted as per Clause 13A.1(b), Schedule 1, part 2 of the Therapeutic Goods (Medical Devices) Regulations 2002) which are included in the Australian Register of Therapeutic Goods (“ARTG) were required to have Patient Information Leaflets (PILs) and Patient Implant Cards (PICs) from 1 December 2021.
The TGA released updated guidance on 14 October 2021 which will allow industry to utilise the consent to supply form in the event of any delay in complying with the new PIL/PIC requirements. This change brings the TGA closer in line with similar European requirements, which are expected to be implemented in 2024.
What to do if you won’t meet the timeline
To ensure continuous supply of a device which does not comply with the PICs/PILs requirements after 1 December 2021, sponsors will need to submit a consent to import, supply, or export a medical device to the TGA, using the TGA guidance. An online consent form is also available on the TGA website. The required information related to non-compliance to the Essential Principles in a consent application includes:
- Selection of specific Essential Principles for which consent is requested (e.g., Clause 13A.2 to 13A.4)
- Description of the non-compliance with the Essential Principle(s)
- Requested duration of the consent to supply non-compliant devices, including a reason why those dates have been selected
- Strategy to mitigate the non-conformance for all ARTG entries/applications. This is an implementation plan that includes information such as the proposed risk mitigation strategy, action plan and when mitigating activities will commence. The TGA has provided examples in the guidance about what is expected of the implementation plan. An interim non-compliant patient card or leaflet should also be uploaded as part of the implementation plan.
What you need to be aware of
- This interim measure is only applicable to existing ARTGs and applications that are made before 1 December 2018. Any new applications or devices that entered the Register on or after 1 December 2018 are not eligible for the consent to supply.
- While each application may include multiple ARTG entries, if some of the ARTG entries/Applications for Inclusion have different implementation plan(s), interim PICs/PILs or proposed consent durations, a separate consent for supply application will be required.
- If the device is non-compliant with the Essential Principles, sponsors must ensure they use the correct form. The TGA has provided different forms depending on which Essential Principle the device does not comply with.
- The processing fees for each entry will be reduced to a flat fee of AU$30 from previous fee schedule comprising AU$500 for the first application, and AU$100 for each subsequent ARTG entry. A refund request for fee difference can be made to the TGA for sponsors who have lodged consent applications on or after 1 January 2021.
- Electronic PICs and/or PILs rather than hard copies will be considered compliant if they contain all required information and are made available in a way that is readily accessible by the patient concerned. In such case, consent to supply will not be required.
More positive change on the horizon
Currently a number of implantables are excluded from the requirement to provide patient information materials, as listed in Schedule 1, part 2 of the Therapeutic Goods (Medical Devices) Regulations 2002. TGA will allow more “similar items” to be added to the excluded list, which may include pedicle and laminar screws. This will be clarified by the TGA in their upcoming guidance.
If you have any questions about or need assistance with patient implant cards and/or patient information leaflets in either Australia or Europe, be sure to reach out to PharmaLex team for a no-obligation discussion.