Webinar presentation: Viewing and responding to notifications in the Consent for Non-compliance Dashboard

Thank you everybody, my name is Rachel and I’m from the TGA Conferencing and Events team and I’ll be your moderator for today’s event.

Firstly, I’d like to acknowledge the traditional owners and custodians of the land on which we meet today and pay my respects to elder’s past, present, and emerging. I’d like to extend that acknowledgement and respond to any Aboriginal Torres Strait Islander people here with us online today.

Slide 1:

1. morning everyone, my name is Kathryn Fuller. I’m the Assistant Director of the Post Market Reforms and Reviews Section in the Medical Device Surveillance Branch of the Therapeutic Goods Administration. Thank you for joining us today to discuss the new features on the 'Consent for Non-compliance Dashboard'.
2. Sponsors can now view and respond to notifications related to devices that do not comply with the Essential Principles. Notifications may include in any informal requests for additional information regarding an application, letters advising at the outcome of a submitted application, and regulatory letters related to devices that are part of an approved consent application.

Slide 2: Webinar Overview

1. Today’s webinar will be divided into a few parts; we will go through some introductory slides and then a live demonstration of the new features on the dashboard. Any remaining time will be dedicated to a question and answer session.
2. The topics covered by the webinar today will be brief introduction on when and why you may need to apply for consent, an introduction to the different types of notifications relating to consent applications, how to view the notifications, how to draft and send a response to a notification, and how to request an extension to notification response due date.

Slide 3: Background

So let’s begin with a refresher on why you may need to apply for consent for non-compliant devices. A reason you may need to apply for consent to import, supply, or export medical devices that are non-compliant with the Essential Principles is because there are criminal offences under Section 41MA, and civil penalties under Section 41MAA of the Therapeutic Goods Act if you supply non-compliant medical devices, unless consent has been granted by the Secretary of the Department of Health and Aged Care. While the TGA expects and requires compliance with the Essential Principles there may be some extenuating circumstances preventing compliance to one or more parts of an Essential Principle for a limited period of time. If this is the case, then you can apply for consent for the medical devices even though there are some non-compliances. The TGA will review the risk of supplying the non-compliant medical devices with consideration to the risk mitigation strategies that the sponsor or manufacturer are going to put into place for this period of time.

It should be noted that if your non-compliant medical device is currently part of an application to vary the device, or manufacturers evidence, or you have an Application for Inclusion in the ARTG and the device is going to be supplied whilst non-compliant with the Essential Principles you will still need to apply for consent.

Slide 4: How to apply for consent

If you are seeking consent for supply of non-compliant devices, an authorised representative of the sponsor needs to complete and submit the relevant application form, which can be located on the TGA website on the ‘Essential Principles – Consent for Non-compliance’ web page; this web page also provides you with a copy of the guidance document on how to complete the application form.

In the application you need to upload all relevant documentation, such as the risk mitigation strategy and the implementation plan; and then pay the applicable processing fees in full. The delegate of the Secretary will take all relevant information into consideration when determining whether to grant consent. A notification will then be sent to the sponsor advising them with the outcome yesterday, we presented a webinar on how to apply for consent, so if you missed it, you will be able to access the recording on the TGA website shortly.

Slide 5: Notifications

Now that we’ve had a refresher on the reasons for the consent and how to apply, I’d like to talk briefly about the types of notifications related to consent applications. The new release of the ‘Consent for Non-compliance Dashboard’ delivers functionality which gives sponsors the ability to view and respond to a range of notifications related to their consent applications. This means that dashboard will now be a One-Stop shop for your consent applications throughout its lifecycle.

Notifications you may receive on the ‘Consent for Non-compliance Dashboard’ include an informal request for additional information regarding a submitted application that requires more information to be able to make an informed decision or a response to a notification. For example, if a delegate assessing a submitted applications requires more information to be able to make an informed decision regarding the outcome, they may send the sponsor an additional information notification asking for clarification or for some additional documentation. This is different to a Section 41JA request for information notification, as it is an informal request for additional information to assist the delegate with the assessment of your application.

Another type of notification is one advising the sponsor of the outcome of the submitted application. These include consent approval or not approved notifications, a notification regarding an application withdrawal, so if you withdrew the application after submission the TGA will send you a notification to conform that you’ve withdrawn it, consent revoked, and consent expired applications. For approved consent notifications, the approval notification will be the notification that you will be requested to response to and submit evidence of compliance for all the devices before the end of the consent period. We will cover this in more detail in the live demonstration.

The last type of notification you may see on the dashboard are regulatory letters, these are regulatory letters related to devices that are a part of an approved consent applications. These can include but are not limited to Section 41JA request for information, Proposal to Suspend or Cancel a device, Cancellation or Suspension letters, and letters relating to Conditions of Inclusions. These notifications will work in a very similar was to those send to sponsors in the ‘Post Market Review Database’. There will be some notifications that will require a response from the sponsors, such as Section 41JA request for information, and others that sponsors do not respond to, such as cancellation letters.

Slide 6: TBS Application Form

Now that we’ve discussed the different types of notifications let’s have a refresher on how to access the dashboard. The Consent for Non-compliance is hosted on the TGA Business Services site or TBS as we call it. You log in as you would normally for any other applications or adverse event reporting, and then under the applications drop-down menu, select ‘Medical Device Post Market Compliance’ option under the ‘Regulatory Compliance’ heading. This will take you to the ‘Post Market Review Compliance Dashboard; where you can select the ‘Consent for Non-compliance Applications’ tile to access to the next dashboard, where you will see the notification related to your consent applications.

I will now switch over to a live demonstration of the ‘Consent for Non-compliance Dashboard’ and shown you how to view, draft, and submit responses to the notifications.

Live Demonstration - Dashboard Overview

1. One the ‘Consent for Non-Compliance Dashboard’ you will see three tabs. Here on the ‘Draft’ tab you can view and edit all your consent applications, these are applications that are yet to be submitted. On the ‘Submitted’ tab you can view all your previously submitted consent applications and have a look at their status here to follow them through. You are able to see whether they have been approved, not approved, revoked, or expired.
2. The tab and view we are interested in today is the ‘Notifications’ tab where you can view and respond to notifications related to your consent applications. Like the other tabs in the ‘Draft’ and ‘Submitted’ views you can sort the table by clicking on the different column headers. Let’s go ahead and have a look at the information that is included in this table, you can see here that the first column is the notifications ID and this is the unique identifying ID for this particular notification. You may notice that it does have the CTS application ID number in the front, followed by the name or type of the notification. Here we have the CTS application ‘00192’ and this here is a consent approved notification. If you click on this, it will order them by numerical order.
3. Next, you will see this column which is the application name, and this is the name of the consent application to which it is relevant. This is the name that we gave our application when we created it. We’ve got the ‘notification type’, ‘consent approved’ notification, ‘not approved’, ‘application withdrawn’, ‘additional information’, and if it was a regulatory letter, it might have the name of the regulatory letter in that as well.
4. Here we also have the status of the notifications and here you will see three different statuses, ‘Sent/awaiting response’, ‘Completed’, or ‘Expired’. Where you see ‘Sent/awaiting response’ this indicated that this is a notification that requires a response from the sponsor and that the notification is current and is awaiting your response, and you will see the response due date.
5. Where you see ‘Completed’ it can mean one of two things, it may mean that this is a notification that you cannot respond to, if that is the case, it will automatically come up as ‘Completed’ when it appears in the portal and there will be no response due date. You can see in this example, this is an ‘application withdrawn’ notification, a ‘consent not approved’ notification and a ‘revoked’ notification, and these particular types of notifications do not require a response from the sponsor. The other type of ‘Completed’ will indicate that a response has already been received against that notification, so you can see here against an ‘approved’ consent notification we have got a due date, but it says ‘Completed’, this means that a response has already been submitted. Once again, we have got the response due date and the response received date.
6. You can also use the search box to search for a notification. You can search by typing in the name of the application, the consent application ID or if you know it, the notification ID itself, you can also do a partial search using the asterisk as a wild-card character. For the example today, let’s search for all the notifications related to one particular consent application. I know the number, so I am going to type that in and select the magnifying glass. You can see here that we have four different notifications related to this consent application, a cancellation letter for a device or devices that are part of this consent application, a Section 41JA request for information for the devices that are also part of this consent application, an additional information notification and our consent approval notification. You can see that the cancellation letter has no response due date as you cannot respond to this notification, whereas the other notifications have a responses due date in columns provided and the notification status is ‘Sent/awaiting response’.

Live Demonstration - View a Notification

1. Firstly, I would like to show you how we can simply view a notification and we are going to view the cancellation letter. If we click on the ‘down arrow’ button along the row of the notification that you want to view, some options will come up. If we choose the ‘preview’ function this will open it up on another page for us to be able to view and print, so we can go ahead and do that. Select ‘preview’ this will bring it up in this format where all the information and all the different parts of the notification will appear on one page. If you need to print, you simply select the ‘print’ button, and a window will appear when you can select to save as a PDF or you can select the ‘print’ button. To return to the dashboard you can simply select the ‘back’ button, this will bring you back to the ‘Notification’ dashboard, but you can see that we have lost the filter for looking at notifications relevant to just that one application. I will just enter that again. Another way that we can view the cancellation, or any type of notification is by selecting the ‘view details’ option. If we select this, it will display the Consent for Non-compliance ‘Notifications’ view, where there will be five non-editable sections related to the notification. If we click on the ‘Notification Details’ section, we can view the notification ID and the consent to supply application number to which this is relevant to. We also have a section down here for all the notification documents relevant to this notification, in the emails folder at the bottom of this section will be the email and letter associated with the notification that were sent by the TGA. For this example, it will be the email that was sent to the sponsor and a copy of the cancellation letter.
2. You may have noticed that the ‘Notification Details’ section changed from blue to green when we clicked on it, this indicates that the information in the section is auto populated and is complete. If we go ahead and click on the ‘ARTGs and Applications for Inclusions’ section, we will be able to view the devices related to this particular notification. A notification may relate to all or only some of the devices in the consent application. If you have more than four devices you will have to scroll through to the second page here to be able to see them. You will note that this section will also change from blue to green when clicked on as all the information here is also auto populated. If we click on the ‘Non-compliant Essential Principles’ section, we will be able to view the Essential Principles related to the notifications, the EPs in the sections may be different to the EPs related to the consent application as this is populated by the TGA when they raise the notifications. For this example, the cancellation letter may be related to a different EP to the non-compliant EP for which consent was granted. When we open the ‘Sponsors Response’ section we can see that there are no responses to this notification, this is due to the fact that this is a cancellation notification, and no response is required by the sponsor. For other types of notifications that require a response, your details after submitting a response to a notification will be populated in this box, I will show you this in another notification. Similarly, for this particular notification, no extensions can be granted as it is a cancellation letter. For other notifications where an extension to the response due date is possible, if an extension has been requested you will see the details in this section. I will show you this in a different notification, and please note that notifications can be viewed by users with either ‘drafter’ or ‘submitter’ access. Any authorised user can view notifications. I have just selected ‘back’ there and as you can see it has taken me back to the ‘Notification’ dashboard. I will filter it back down to our notifications relevant to my consent applications.

Live Demonstration - Responding to a Notification

1. Now that we have gone through how you can view a notification, I’d like to demonstrate how to draft and submit a response to a notification. A response to a notification can only be submitted by an authorised user with 'submitter’ access to the TBS portal. If you have draft access and are not authorised to submit a response you will only be able to draft and save a response.
2. Today we are going to draft and submit a response to the consent approved notification. When the consent application is approved, a notification and letter of approval is issued by the TGA and will appear in the notifications table. As part of the consent process sponsors are required to provide evidence of compliance with the Essential Principles before the end of the consent period. You will provide this evidence as part of your response to the consent approved notification. You can submit you evidence of compliance in multiple responses as devices within the consent application can become compliant throughout the consent period and this is different to all other notifications where you can only submit a response to a notification once. The consent approved notification is a little special.
3. To respond to the consent approved notification, or any other notification, we click on the ‘down arrow’ button on the right-hand side and select ‘draft’. On this view, you will notice that there are five sections related to the notification. There is an option here to expand all sections at once or you can expand one section at a time by clicking on the section you want to work in. The ‘Notification Details’, ‘ARTGs and Applications for Inclusion’ and ‘Non-compliant Essential Principles’ are all non-editable. These sections can change from blue to green when selected indicating that all mandatory information in the section is auto populated and already complete.
4. I have opened the ‘Notification Details’ section here and you can view once again the notification ID, the CTS application number that has been approved, the documents folders here and in the emails folder same as before you can see a copy of the email and the approval letter that was sent to the sponsor for this consent application. You can also see that there is another folder in the section indicating that a response has been provided previously, for this example, we have already submitted compliance evidence for some but not all the devices in this consent application. If I click on this folder, it will bring up all the documents that I uploaded as part of my response and I will be going through and showing you this for our response we are about to create.
5. In the ‘ARTGs and Applications for Inclusions’ section you can see all the devices that have been given consent in this approved consent application. In the ‘Non-compliant Essential Principles’ section, it will show you the EPs which the devices are non-compliant with and for which consent has been granted.
6. To create a response to our notification, we are going to click on the ‘Sponsor Responses’ section, and you can see here as mentioned previously a response has previously submitted and this will appear here in the table. Please note that you cannot edit a response that has already been submitted. For this example, let’s pretend for our demonstration that response one was when we submitted compliance evidence of all four ARTGs but only against EP 13 and we now want to provide a response for all ARTGs against the remining EP, which is EP 3. Due to the evidence that we are going to submit we’d like to provide this evidence in two groups, one for the first two ARTGs and then another lot of evidence for the second one. We are going to create two response groups in this particular response submission.
7. To create our new responses to provide our compliance evidence against EP 3 we need to click on the ‘Add Response’ button, this will open a new window in the current view where you can provide a relevant name for the response. For this example I will call this one ‘EP 3 for ARTG one and two’. You could write the whole ARTG number here, but just for speeds sake I am going to write one and two as we have four in our application. This will create our response and name it, and it will appear in our table ready to edit and add evidence of compliance. At this step, because it is creating folders in the background it sometimes can take just a little while to process.
8. You can now see here that we have the response name but there no details in there and no attachments yet, we are now able to go in and edit the response and provide these details. Click on the ‘down arrow’ button and select ‘edit’, this will open a new window in the current view. Here you can change the name if you would like in the box provided. By default, all ARTG entries and Applications for Inclusions and relevant EPs to the notification will be included in the response, if you are not providing compliance evidence for all these devices within the consent period at this time, or if you wish to provide multiple response like we are going to do today, you will need to exclude the devices not included in this response group. We are providing evidence for ARTG one and two, so ARTG three and four here need to be excluded. To do that, click on the ‘down arrow’ button and click ‘exclude’. This will update our table with a ‘No’ to show that these devices have been excluded from this response. The same thing goes with the Essential Principles, as we have mentioned before in our example, we know that the first response delivered the evidence of compliance for EP 13, and this is just relevant to EP 3. I have excluded EP 13 here and you can see that the table has been updated and this EP has been excluded.
9. The next step is to select how you want to provide a response, responses can be provided by typing a summary in the free text box provided or by attaching relevant documents or by providing both a summary and documents. Documents can be uploaded in Word, Excel, and PDF formats with a file size of up to 50MBs. For this example, we are going to do both, a summary in the box provided and we are going to add a file. To add a file, simply select the ‘Add Files’ button, click ‘Choose Files’ box and select the files you want to upload from your computer’s Explorer. Attach a document and click ‘Add File’, you can see here this document has been added. If you make a mistake or if you come back to this later and decide you want to update it, you can delete the document. For example, I have accidentally uploaded the wrong document and I want to replace it, I can simply use the arrow button and select ‘delete’, a pop-up will come to ensure that you want to delete this, select ‘delete’ and it will delete the document on the response. I will now just go ahead and add the correct one, simply click in the ‘choose files’ box, it will bring up my Explorer and I’m going to select Part A of my evidence, click on ‘Add file’ and you can see my document has been uploaded. You can upload more than one document and just repeat the process. For this example, I want to upload Part B of my evidence, I will just go through the same process again and select ‘Add Files’ and you can see I have both documents here. Once done, we need to select the checkbox to acknowledge that at least one file has been uploaded, select ‘save’ to save the response. You will be able to see that the added response will display in the table, a summary of the information and we have a ‘Yes’ to the attachment. If you need to change anything in the response, simply click ‘edit’ or ‘delete’ this response, as long as you do this prior to submitting the response.
10. We want to submit another response group for the evidence for ARTG three and four, we simply just go through the same process. This is going to be EP 3 and for ARTGs three and four. We select ‘save and close’, this will create the response and add it to our table for which then we can go in and edit. Once it is there, select ‘edit’, I am happy with the name and you can see here that there are no records to display. There is no ARTGs appearing, sometimes you need to just simply refresh the table by clicking on any of the column headers and it will refresh the table and those ARTGs should appear. This time we are going to exclude the first two ARTGs, because we have just submitted evidence of those and like our previous group, we're going to exclude EP 13 because we have already submitted evidence to that in the very first response before today and we just want to give evidence against the EP 3. Let’s write a summary and attach your document, add your files and you can see here that it is added our evidence of compliance. We can delete and change that if we need to but we're happy with that. We acknowledge that at least one file has been uploaded and we select ‘save’. Once again, you can edit or delete a response by clicking on the down arrow button and choosing the relevant option.
11. All the documents that we have uploaded as part of our responses are now going to appear up here in our ‘Notifications Details’ section. A SharePoint folder is created for each response to this notification and is listed on the table in chronological order. If you see that your response folder is not appearing on the table, just click on the column header to refresh the table and your folder should appear. If you want to have a look at the documents you can just by clicking on that folder for response number 4, this has got the document in here.
12. You may notice that the ‘Sponsors Response’ section has remained amber even when you have provided all the information. This is a design change from the application form, it is just slightly different. This section will stay amber even if you provide all the information required. Don’t panic if it stays amber, that is by design.
13. The next section we have is the ‘Extension Request’, this is where you can request an extension to the consent period and view any other previous requests for extensions and their decisions. You can see here that we've already requested, and had approved an extension to our consent period. We proposed that the consent period be changed to the 13th of October 2023, and the TGA approved this decision and agreed with the date. We will take you through how to apply for an extension, but at this point, I don't need another extension because I've actually just submitted all the compliance evidence in this last two response groups and I'm ready to submit the final response to this notification. If you are someone with drafter access and you have drafted this response, you will not be able to validate and submit this response, you will simply have to press ‘back’ and all this work that you drafted into this notification will be saved and someone with submitter access will come in at a later point of be able to submit it. I have submitter access and I would actually like to submit it, once you are ready to submit your response to the notification, ‘select the ‘validate’ button. This will bring up another pop-up box, which will ask us if we do want to proceed to submission, which I'm going to select as, ‘Okay’. This will bring us to another page where it lets us know that the notification has been successfully validated and we've got two options, we can click on the ‘preview’ button to preview the response and if we click that it'll come up in the same format that we saw when we previewed the cancellation letter. It will come up all on one page for you to be able to review the notification and the response details and from there you can print. By selecting ‘preview’ however, we're not done yet we still have to declare and submit. So, if you choose ‘preview’, it will open up in another tab and you'll have to return here to be able to then declare and submit. I don't need to preview at the moment, I'm going to go forth and declare and submit. I read the Declaration and I understand that's the final submission and that this information will be used by the TGA in evaluating compliance with the Therapeutic Goods Act and the Therapeutic Goods Regulations. I understand that the documents and information provided is required to be in English. I select ‘Yes’, and submit, a pop-up box will come up here, asking me if I'm sure I want to submit the notification and select ‘Okay’.
14. This will bring you back to the ‘Notifications’ tab, I still want to filter back down to my responses, and this is a bit of a glitch, usually this would now say ‘completed’, this is a lower testing environment that we are showing you today and sometimes in these environments there can be glitches. However, in the production environment in which you will work in this will not happen.
15. If your response to the consent approval does not provide evidence for all devices and EPs, the TGA will have to reopen the notification after reviewing it to allow you to provide additional responses to cover the remaining devices and EPs. Once you submit your response to the TGA, staff will review information and if you don't supply all the evidence against all the EPs and ARTGs they will change the status of the submission from ‘completed’ back to ‘sent/awaiting response’ to reopen the portal and allow additional responses. For example, if you submit a response to your consent of approved notification on a Monday, and then on the Tuesday, you think I'm ready to submit another lot, but you go back in and it still says ‘completed’ here in the status of that notification, that just means that the TGA hasn't had the time to go in and review your documentation and reopen it. You can email us at, mdconsent@health.gov.au and let us know that you would like that consent approved notification to be reopened so that you can provide additional compliance evidence and the staff will do that for you.
16. That is how you draft and submit a response to a notification, back here on the ‘Notification’ dashboard we can also preview details, if you want to save as a PDF or print your response to this notification.

Live Demonstration: How to submit an Extension Request

1. I would like to show you how to request an extension to a notification and we will do this for our section 41JA request. If you are having difficulty providing the information to a notification in the required time frame you can submit a request for an extension to the due date. All extension requests will be considered by the TGA on a case-by-case basis. A request for a date extension request can only be submitted for notifications that are current and have not expired. The notification status of a current notification will be displayed as ‘sent/awaiting response’, so we must see ‘sent/awaiting response’ for you be able to draft and submit an extension request, if it is expired already, you are not able to do that. Please note that only uses with authorised ‘submitter’ access for the TBS portal will be able to draft and submit an extension request. Users with the ‘draft’ access are not even able to draft or submit an extension request.
2. Let’s go ahead and have a look at our section 41JA request for information notification and then request an extension to the response due date. To do this, we're going to click on the ‘down arrow’ button and select ‘draft’ as we did for the other notifications. We can view the information related to this notification by clicking on the different sections. We can expand them all at once or do them one other time. Here are the details pertaining to my section 41JA, we've got the notification ID and the CTS application number to which this is relevant. Once again, we've got our emails folder where we can view the email and the section 41JA regulatory letter that the TGA sent. When I click here, I can see all the ARTGs or Applications for Inclusions that are relevant to this section 41JA. Just a reminder that this may not be all the ARTGs in your consent application, just what is relevant to this section 41JA. If you have more than four ARTGs you may need to scroll over to another page. In the ‘Non-compliant Essential Principles’ section are the Essential Principles that are relevant to this section 41JA. In the ‘Sponsor Responses’ section, you can see that no response has been created because we haven't done it yet, and in fact, we need more time and that's why we're going to request an extension.
3. To request an extension, we simply click on the ‘Extension Request’ section, click on the ‘Request Extension’ button and this will bring up a new window in the current view. Here you can see what the current notification due date is, and you can select a new proposed due date. Let's say we need to the end of November to provide this information, simply enter the new proposed date and a reason.  These fields are marked with a red asterisk, meaning that they are mandatory, and we must provide an answer. We have got two options here, we can either submit this request now or we can save it and come back later. For example, I'm pretty sure that that's the date that I'll be able to do it, but I'm not sure. I want to check a colleague; I'm going to select ‘No’ but I'm going to save it, and this will save it in draft in my extension request. You can see here that the extension request has been added to this table, but there's no decision. I haven't submitted it and there is no due date yet either, you can see that it hasn't been submitted. Let's say, I go and check with a colleague and then come back and you do want to submit this now, to do that I simply select ‘edit’, I can change the date and I can change some of my explanation. This time I'm going to select ‘Yes’, I would like to submit my extension request. I scroll down to the bottom and select to ‘save’, a pop-up box will let me know that once I submit the request you are not able to change the details and ask me if I want to go ahead and submit this request, which I do and select ‘Okay’.
4. You can see here that the table will be updated with the request details. Once submitted, the request decision will display as ‘pending’ until a decision has been made by the TGA. If the extension request has been accepted by the TGA the decision will appear as approved. The notification response due date will be updated with the new due date from the TGA as they may select a different due date to what you propose. If you propose something that's a little outlandish, the TGA may give you a different new due date, and that will be populated here. If the request has been rejected, the extension decision will be displayed as ‘Disapproved’. And the response due date will remain the same as before. As we have simply requested an extension for this notification and we are not submitting a response to this notification at this time, we do not press the ‘validate’ button, we simply select ‘back’ button to return us to the notifications view.

Slide 7: Additional Information Notification

1. You can see it's brought us back and I am just going to filter down to my notifications relevant to this particular application. So now we've seen how we can view a notification, draft and respond to a notification, and how to request an extension to a notification. I would now like to show you the additional information notification.
2. If the TGA requires further information for the review of your submitted consent application or for a response to a notification, you will receive an additional information notification. This notification is different to a formal section 41JA request for information and has no letter attached to the email. All details of the request will be included in the email that the TGA sends you. You can view that email again by clicking on the emails folder in the ‘Notification Details’ section. Just before we have a look at this notification, a reminder that this notification is one you can only submit a response once. As we've mentioned previously a consent approved notification is the only type of notification here that you can submit a response more than once. A response can only be submitted once for every other type of notification, all the regulatory letters and the additional information notifications.
3. The consent approved notification is a bit different and special; you can create multiple response groups within your notification response as we did before. We did two different groups in the one response, but you can only submit the response once. You must ensure that when you do respond to a notification that is not ‘consent approved’, any of the others that your response is covered all the devices and EPS in the notification before you submit the response to the TGA.
4. Let's have a look at this additional information email notification. To do that, simply select ‘draft’ from the drop-down menu next to the notification. This will bring it up in our notification draft view. The same thing here, we can expand the sections to have a look at the different information, we can view the email here and once we have responded our response folders will come up. Here we have all the ARTGs that they are asking additional information about, you can see here that there's two. You might notice now that there is no section here for ‘Non-compliant Essential Principles’, this is because the information that the TGA is requested is not relevant to any particular EP. It just asking for some additional information here on these two ARTGs so the section for EPs will not appear and that is okay. Once again, if we want to provide a response, we simply go ahead and go through the process of adding a response here and the same thing if we wish to do an extension request for this particular notification. We can do that by requesting and extension and going through the same process. I just wanted to show you this additional information because it's a little different in that there were no EPs selected in this.

We have covered a lot and I think that can be the end of our live demonstration, please just a reminder that we do have a lovely guidance document that will walk you through all of these different things, viewing, responding, asking for an extension, on the TGA website and also that this webinar will be recorded. And of course, if after looking at the guidance document, you're still a little bit unsure, you can always email us at mdconsent@health.gov.au to get more information.

I'm just going to end my live demonstration and return back to the webinar.

Slide 7: Questions

I’d like to introduce Dipti Mehta, she is part of the Reforms and Reviews team and has been instrumental in building the features that we have shown you today, so if I can’t answer any of the questions Dipti might be able to. Of course, if some of the questions we’re not able to answer at this time we will take them on notice and get back to you.

1. Will I be able to provide evidence of compliance for a device that was initially a part of Application for Inclusion and after approval has an ARTG entry number?

Yes, if you do have an Application for Inclusion that is part of a consent application, that becomes approved and it gets an ARTG, what will happen is that the Devices Application Section tells the team that take care of our consent applications that a new ARTG has been given to that and the TGA will actually update that approved notification with that ARTG number, and it'll update in the portal so that when you go back into it you will see that ARTG number has been added. So of course if you go in and see that hasn't happened yet and you've got your new ARTG you can email us at mdconsent@health.gov.au and let us know and we can update that. And then, of course, you can then provide evidence of compliance for that new ARTG.

2. Can I request an extension of the consent period and if so, how do I submit extension requests?

Yes, you can seek extension for the consent approval period, and you would do that simply by going through the same process that we did today, you would draft a response, and it would go down to the extension accordion and go through that process. It's important to note though, that you can only request an extension if the notification is current and not expired. You can't ask for an extension to the approval period, the consent period, if it's already expired, you need to do it beforehand. Otherwise that notification becomes expired, and you won't be able to go in and request it so do it while its current, and you can do it in that method that we showed you today against the consent approved notification.

3. Can you confirm that the CTS portal is not where the TGA will send sponsors 41JA letter for current medical device applications?

We have the Post Market Review database and the Consent to Supply database. If the section 41JA is related to a device that is part of the current approved consent application. It will be sent through the CTS database for these notifications. If it is for a different ARTG that is not part of an approved consent application it will be sent in the normal PMR dashboard and you can see that they're very similar, it's the same database, it is built in the same way and so hopefully there's a bit of familiarity there if you've answered a section 41JA in the portal, you'll notice that it looks and feels pretty similar to that. So, yes, it depends on the ARTG, but if that ARTG is part of the consent approved, it will come through the CTS database.

4. If I need to add a document to support a submission, do I simply request through the email?

It would depend, if you're creating a response and you want to submit your document, you do it through this format. You would go in, write your response, and add your document there. If you submit your response and you realise that you have forgotten to add a document, or you need to add some different information, but it's already come up as complete because basically you get one shot at responding to a notification of course unless it is the consent approved notification, you can always email us at mdconsent@health.gov.au and let us know- ‘Hey, I've just submitted a notification and I forgot to add a particular document, would you please add it’ and you just need to give us the CTS application number and the type of notification or the notification ID so you can let us know and then we can go in and add it from the back end and then it will actually appear when you go in to have a look at the details. So the TGA can update in the back end and then it will refresh on your end and will be able to see it on the sponsor portal. So all is not lost if you accidentally forget, just email us and we can add that extra information in for you.

Slide 8: Contact us

Just a reminder that we have got guidance documents and this webinar will be recorded and you can watch it back on the TGA website. If after reading the guidance documents and having a go yourself, you have any additional questions you can just email the team at mdconsent@health.gov.au.