Unlock the Potency of Digital Signature Legitimateness for Drug Testing Consent Agreement in Australia

How to eSign a document: digital signature legitimateness for Drug Testing Consent Agreement in Australia

so good afternoon everyone my name's catherine fuller and i'm the assistant director of the post-market reforms and review section in the medical device surveillance branch branch of the therapeutics goods administration before i start i'd like to acknowledge the traditional custodians of the land on which we all meet today wherever you are situated and pay my respects to their elders past and present i extend that respect to aboriginal and torres strait islander people here with us today on this webinar thank you for joining us today to discuss the application process for consent to import supply or export medical devices that are non-compliant with the essential principles as this is a bit of a mouthful from here on in i'll just refer to it as the consent to supply form the tga is modernizing this process to move from a standalone paper-based form to an online form the transition has occurred in two phases with the first phase being on interim online form hosted on the tga consultation hub and the second phase being the launch of a new online form which is integrated with your tga electronic business systems account or tbis as we call it the tga post-market compliance system and this is the form that we'll be discussing in today's seminar so today's webinar will be divided into a few parts we'll go through some introductory slides and then a live demonstration of the new form in tbis any remaining time will be dedicated to a question and answer session the topics covered by the webinar today will be a brief introduction on why and when you may need to apply for consent to supply and how and when to apply for consent what the new form looks like and what the tga expectations are in regards to the information that you will need to provide and then i'll touch on the process after you submit the application form including the payment of fees there'll be an opportunity for you to ask any questions that you may have please type your questions when the q a function is open during the presentation into the message box at the bottom corner of your screen and we will try to answer as many questions as we can during the last part of the webinar please note that we will open the question and answer function after the live demonstration so that we have an opportunity to show you the form if we're not able to get to your answers in the time allocated we may need to come back to you on some of the questions so please be sure to include your conduct contact details when you post a question okay so let's begin with a bit of background the reason that you might 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 whilst 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 to supply 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 during this time it should be noted that if you are non-co if your non-compliant device is currently part of an application to vary the device or manufacturer's evidence or you have an application for inclusion in the artg and the devices are going to be supplied whilst non-compliant with the essential principles you will still need to apply for consent if you're seeking consent for supply of non-compliant devices an authorized representative of the sponsor needs to complete and submit the relevant application form which can be located from the essential principles consent for non-compliance web page this webpage also provides you with a copy of the guidance document on how to complete the application form in the application you must upload or include all relevant documentation such as the risk mitigation strategy and 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 be sent to the sponsor advising of the outcome for those applications that relate to non-compliant patient information materials these are deemed to pose a low risk of harm to patients and we acknowledge that the non-compliance may be a result of the differing time periods for implementation of the regulatory requirements between europe and australia therefore we envisage that the processing time for these particular kinds of applications will be rapid and the tga will focus on ensuring compliance with the implementation plan's post consent so the tga is building a new integrated solution for the consent to supply for non-compliant medical devices moving from a paper-based form to an online form and then to an integrated solution a few months ago we developed an interim form on the tga consultation hub to hopefully make the application for consent easier and more streamlined we are now moving this to the next phase of the project which is an integrated solution within tbs neither the paper-based form or the forms on the tga consultation hub will be accessible after one december this year when our new form in tbis goes live new form will be hosted on the tga business services site or tbs as i'll now refer to it you would log in as you normally would for any other applications or adverse event reporting and then select the applications drop down menu from here you would select medical device post market compliance option under the regulatory compliance heading doing so will take you to the pmr compliance dashboard where you can select the consent for non-compliance applications tile to access the next dashboard and start a new application so now what i'd like to do is show you the form in tvs and take you through an application i'm just going to share my screen okay so you can see here that we are now on the pmr compliance dashboard and you can see the consent for non-compliance application tile that i just referred to so if i click on this tile it will take us through to the dashboard here you can see the consent for non-compliance application dashboard we have two views here one where you can view draft consent applications that you have drafted but are yet to be submitted here you can also view any submitted consent applications you can use the search function to search for any of your applications you can do this by typing something into the search box and then pressing the magnifying glass and it will bring up the search results you can also return back to the view at any time if you are doing a partial search you just need to type in the asterisks character as the wildcard and type in a partial search hit the magnifying glass and it will do that search function in addition to the search function you can also sort the columns in order you can do that by clicking on the column header and what it will do is it will search it sorry order it in number so you can do this by title which will do it in alphabetical order or you can do it by reference number and it will do a numerical order and you can also sort on the dates that it was created here when you've got your draft applications you can use the drop down menu to choose an application to edit and make your edits from there but let's go through a brand new application so to start a new application i would choose the new application button on the right hand side of the screen by clicking on this it will open up a new window within the current view and it will prompt me to create a name for our application now this can be anything that mean is meaningful or relevant to you but you do need to provide a name as it is a mandatory field so let's um let's just give this one a name once you type in your name you just press save and close just processing apologies for my bandwidth here okay so once it's done that it's going to appear here in the draft application view from here you can see that it's generated a number a consent to supply application number and this is the number that you will need to refer to in any further correspondence with the tga in regards to this application now to start on this application we basically use the right hand drop down button and press edit and this is where we'll start filling in all the details for our application this will take us through to the view here where you can see all the different application sections now there's two ways that you can actually view the application one is by expanding all the sections at once and this will allow you to see all the questions throughout the application or if you would prefer to do it section by section you can collapse all and then open one section at a time that's what we will be doing as i go through this demonstration you'll notice here that the tiles are all amber in color what that does is it indicates that not all the mandatory information has been provided for this application yet once we've provided this um all the mandatory information these tiles will turn green so let's go ahead and start with the application details by clicking on this section it will bring up all the questions that we need to fill in for this part of the form you can see here that it has already pulled in the consent a supply number that was created when we gave our application a title you can also see that it has brought through the title that we named in this box you can edit the name if you've made a decision that the name wasn't exactly right here it will also provide the sponsored details that is associated with your tbs client profile in tbs the next thing is for you to select what application type you are requesting here you need to select whether you're seeking consent to import export or supply these non-compliant medical devices this is a mandatory field and you must select at least one however it may be appropriate that you need to select all three so you can select two one two or three this is a mandatory field the next question is whether the devices part of this application are actually devices that are currently included in the artg or part of the current application for inclusion an application can be for both sorts of devices this is also a mandatory field and you need to select at least one here let's select both the next question is around why the devices do not conform to the essential principles the drop down menu gives us a few options is this the result of the eu mdr implementation is it a result of the eu ivd r implementation is this the result of the australian regulation changes or if none of these options are appropriate you can select other if you select other you must provide an explanation as to why these devices do not conform you can just type your information in there the next question is about what the real or potential risks associated with the non-conformance if the non-conforming devices were to be imported exported or supplied and here you need to provide an explanation and you can do this in two ways you can either provide an explanation by typing in the box provided or if you've got a document that outlines this um risks you can provide it here so what i'll do is i'll show you by uploading a document what i need to do though if i'm uploading a document is as is a mandatory field i need to write document attached in the box provided so now if i want to add a file basically it's going to ask me if i add files to choose a file from my computer here i just click in the choose files option here and it will open up the file explorer on your computer and here you can select a document it will list it here and then you can just simply press add files and you can see here that it's going to upload a document here you can see now that my tile has turned green and this is because i've answered all the mandatory questions i can go down to the bottom and press save and it closes that section and from here you could save and come back to it later or you can continue to fill in the other sections of the form so what we'll do is we'll start to fill out the next section of the form which is around what essential principles our devices are non-compliant with so here you need to identify all the essential principles that the devices are non-compliant with you'll need to select one ep at a time and then provide details as to why the devices are non-compliant with that ep so to do this i click on the add breached essential principle button this will open up a new window in the current view for me to select in numerical order which ep i'm going to choose first so you might need to scroll down a little bit to find the ep that's relevant to you so say for example our devices have non-compliant picks and pills the first one that we might choose is 13a 2 patient implant cards so i select that and here i need to provide the details as to why our devices do not have compliant picks once you've done that you need to press save and close for this to be added to our application so you can see here but by saving and closing we've got the ep 13 a2 added to our table and also our explanation as to why the device does not comply we now might want to add a second one so if we've also got non-compliant pills we would add another breach to central principle we would scroll down until we find the one that's relevant to us select it and then provide the details and then hit save and close and then the table will be updated with our second essential principle so you can see here that i'm adding one essential principle at a time so that i am able to provide the explanation as to why the devices are non-compliant but i can add as many essential principles that are relevant to this application if you decide that you want to edit the information that you've put in you can simply select edit from the drop down arrow button here it will bring it back up and maybe you can add some more information or you can delete some information so it gives you the ability to add here and you can just press save and close in addition if you decide that that wasn't the right ep you can also delete that from the table using the delete function once again if we finished selecting all the essential principles that our application is relevant to we can hit save and this will save our information bring us back to the front screen and from here we can either you know leave and fill this in later or we can continue with the application so let's continue we're going to choose device groups so here you can create a group for all the devices within the application that have the same proposed start date and proposed end date for the consent period and also the devices that have same implementation plan for example if you have 20 devices which can be artg entries or applications for inclusions um of which maybe five devices have the same proposed start and end date for the consent period and the same implementation plan these five devices can be grouped together into this application similarly the the remaining 15 devices can also be grouped by start and end dates and implementation plans you must have at least one device in a group and you must provide at least one group there is no limit to the number of groups that you can create but yeah you must create at least one group and each group must have at least one device in it and please also note that you cannot have the same device as included in multiple groups you can only have one the same device in one group only so let's go ahead and create a device group we can do this by clicking on the add device group tile here this will open up another window within the current view for us to provide a name for our group we can name it anything we want and as long as it's relevant and meaningful to you to be able to differentiate the different groups that you may have within your application you can name it what you want here we just save and close the name for our group by doing that you can see here that the name for our group is now appearing in our group table but you can see here that we're yet to enter any devices so now we use this button here to press edit and this is where we're going to add in the devices and our start dates and stock information for this group so you can see here that this has opened a new window within the current view for us to start adding some devices you can see this validation error here this will stay until you add at least one device to this group so to begin with we can select what artg entries are part of this group and remember you can have artg entries and applications for inclusion or one or the other but because we've selected both in this application we're going to put both into this group today so to add an artg i simply click on the add artg buttons and it opens another window within our current view for us to select the artgs that are part of this group we can do this by ticking in the boxes provided just by highlighting them you can untick if you've made a an error there or you can also search and you might decide to search by class so say for example let's go class 3 and that should demonstrate the class 3 device and we can select it there once you've selected it you can just press add down here and that will add that artg to the group and you can see that before we did our search we had already selected a couple of artgs so these are the artg numbers now that are part of this group and if we've made a mistake we can remove one of them from the group it will come up with a confirmation that you do want to remove that artg simply confirm and it will remove it from the group the next section is where you can add your applications for inclusion and then provide stock level information if relevant so to add an application for inclusion i simply click on the application for inclusion button which will bring up another window within the current view for us to add in the application number so here you would add in your application number which is generally in a format similar to this and then provide the device name these are mandatory fields so you must provide a device name and the application number then just hit save and close and then you can see now we've got our two artgs that we selected and now we have our application for inclusion also included in our group here so now if it's relevant we can also go in and enter stock information so here at the artg level we would click on edit and this will bring up the box to go and start providing stock level information for this particular artg entry you can see that it has the artg name here and we can provide stock level information so you're just typing in a numerical value here because you're going to indicate what the units of measure are in another field so current and future you can fill in and this is where you're going to say what those units of measurement were so it might be a box a pack each if you do select other this is where you just need to specify the number of devices in that unit that you selected so you might decide that in um you might have packs of two so you'd just choose other and put the two in there here you can provide the expected depletion date of stock by clicking on the calendar icon it will bring up a calendar you can scroll through to the date that you expect all stock to be depleted choose the date and then move to the next one this question is around whether there'd be any supply shortage if the consent to supply is not granted here you can choose yes no or unsure if you choose yes or unsure then you need to provide an explanation as to yeah the supply shortage so you can just type the information in here there are a couple more questions one is around the additional impact to australian consumers if the consent is not approved you might like to provide this information as an additional kind of reasoning for your consent application you can choose yes no unsure like the question above if you if you choose yes or unsure you a box will be provided for you to provide your explanation once you've filled in this information you just press save and close and then you can see here that um our table has been updated with our stock level information so you can move through these artgs and add our stock level information for each one if you're seeking consent for a long period of time it may not be relevant to have stock level information and you can see that a lot of the information is not mandatory the device name has already been provided and you can see that there's no red asterisks for this these questions so once we're happy with that and so we've got all our devices in our group we're happy that we filled in the stock level information that we want to provide um this is where for this particular group we now need to nominate our proposed start date and end date for the consent period so here you simply click on the calendar icon and select the date that you wish to start the application for consent so let's say we wanted to go december 15th you just select that date and perhaps we want to go through through to may 2023 you can just select the date there please note that um the start and end dates must be within three years of um each other here you need to provide a reason for the duration so you just type in your ease in there and you can see that that's a mandatory field and the next box is sorry um for batches now for once again for periods of consent or applications for a long period of time batch numbers may not be relevant but if you're seeking consent for a short period of time for a small number of devices then it might be relevant here to provide the batch numbers the next section is around the strategies to rectify the non-compliance and this is where you must provide an explanation around the strategies to be implemented or proposed to be implemented to rectify the non-conformance for this group and this is where you would either upload some documents from your computer or you might be able to provide details in the box here but if we're going to add some files in here what i'm going to do is i need to write documents attached or document attached so that we know that there are documents attached once again if i add on the add files i can select on the choose files button it should bring up your computer i can select the implementation plan here select it and then press add files and you can see here um so the implementation plan actually if i just go back up a level these folders will appear before we um uploaded a document but i noticed that when i did that that hadn't done so let's actually put it into this folder here so we want to put our implementation plan into the implementation folder so i can click on that and add files choose it so let's put that implementation plan into this implementation plan folder it's not the end of the world if it goes into the wrong folder we will find it it's all good so let's select that and you can see here now that that's got that document there to go back up we just press the up arrow button and this is where we would also be able to upload a copy of our interim pic and perhaps our interim pill if we have selected devices that are non-compliant with ep 13 a2 and 13 a3 this is where you provide it now for the documents that we upload we've got a 50 megabyte file size limit which hopefully is enough and you can provide this in word format pdf format or excel format we are running a survey um for this form if 50 megabytes turns out not to be enough then you can give us that feedback and we can look at upping the file size but hopefully if you're separating out the documents into across groups and providing them separated by picks and pills then 50 megabytes should hopefully be enough so once we've done uploaded our documents and we've also written in the box that we have attached our documents we simply save and close all this information you can see now that our device group section has gone green and this is because um we have got all the information that we need for at least one group so here you can see we've got our group name the artg is linked to the group our application for inclusion numbers our proposed start date and end date and the date that we created it with the time this column here just indicates that we have completed all the information that's required for this group if we want to go back and edit anything here we've got the ability to press edit and go back and edit or alternatively if we've made a big mistake and we want to do that we could delete this application here so if we want to add a second device group it's simply pressing on the add device group and going through the process again selecting um the artgs the applications for inclusion the ability start and propose date and so forth so once we've done that uh the next section is to provide our declaration to do so we just open it up read the declaration obviously and then if you agree with the declaration and you have submitter permissions in your tb's profile then you can submit sorry tick the declaration and then press submit if however you're a drafter or you're not quite sure yet you can simply save the information that you've done so far to come back and submit at a later date the application will stay in the draft view draft application view until you've chosen to submit so let's submit it so i've i've read and i agree with the declaration and now i'm going to submit the submit the application so it's just processing my internet's a little bit slow okay and now it's returning us to the front screen where you can see here that our cts number here uh is now in the consent application um view rather than in draft because we have submitted it and you can see that i was a submitter and it was submitted during this time um you cannot once you've submitted it you are unable to edit a submitted document because it becomes a legal document um if there's any really dire circumstances that you need to speak to us about it of course you can contact us and just quote the reference number and we can help you with your inquiry if you need to print from here you can simply right click oh no sorry click on the application here click on the application details and this will take you to this view where you can scroll through and see all the information that you have provided and the documents that you have uploaded as part of this application if you need to print you can right click in the middle of the screen here and press print and by doing so it will bring up the option to save as a pdf up here or save as a file onto your computer in the next release sometime in the new year we will have a print function from the dashboard but in this release you can still print you just need to do it through this way so we'll just cancel that out if you need to return to the home screen you simply click on the dashboard again and it will return you here okay i'm going to stop sharing my screen now and we'll just go back to the slides we're just going to talk a little bit about the application fees so once you've submitted the application form you'll need to pay the application fees applications for consent cannot be processed until all applicable fees have been paid in full now the current fees for applications for consent to supply apply to each artg entry and application for inclusion included within the application so the fees are 500 for the first artg entry or application for inclusion and then 100 for each subsequent artg entry or application for inclusion within the application for consent so say for example your application for consent has 55 artg entries 500 is applied to the first artg entry and then 100 to each of the remaining 54 irtg entries which equates to the application for consent costing a total of 5900 but consent to supply that only relates to non-compliant information materials or ep 13a has a different risk profile assessment and follow-up when compared to consent applications relating to other essential principles so on the 29th of october this year amendments to the therapeutic goods regulations 2002 came into effect providing reduced fees for applications for consent to import supply or export devices that are solely non-compliant with 13a the new fees for these applications is now flat fee of 30 for each artg entry or application for inclusion within your application so this means for an application for consent related for non-compliance only related to essential principle 13a where there are 55 artg entries the total cost would be one thousand six hundred and fifty dollars in terms of paying application fees there are two ways to play to pay one is an immediate payment and that's where you have to calculate the total fees yourself and then you can pay immediately after completing and submitting your form using a credit card on the tga website and i'll show you that in a minute the other way is to pay against an invoice if you require the tga to raise an invoice for payment simply complete and submit your application for consent in tbis and then the tga will raise and send the submitter an invoice for the processing fees but if you do wish to make an immediate payment which is the quickest way you need to calculate the total fees for your application based on the number of artg entries or applications for inclusion and the current fees being 500 for the first irtg entry plus 100 for each of the remaining artg entries as described in the previous slide or if it's for an application solely related to ep 13a is 30 per device within your application then you need to go to the tga payment page and we have the link there and this is also a link in our guidance document in the biller code you need to choose option nine exemption under s41ma then enter your client id in the box provided then in the box where it says artg number you simply provide that cts number that was generated when we developed the when we drafted the application so that's that reference number so you just need to put that reference number in the box and then we'll be able to know um that that's your application um enter the total number of fees that are to be paid select the payment method so that is the credit card and then follow the instructions to complete the payment once the fees have been paid the post market team will receive the application if insulin insufficient information or documents are provided in the application you will be emailed to provide any missing information an email with the consent to supply decision notification will be sent to the submitter to inform you of what the the outcome of the consent application is during the period of approved non-compliance you may be required to demonstrate evidence that you are following your approved implementation plan please be aware that consent may be withdrawn at any time if there is non-compliance with the approved implementation plan or if the implementation plan is audited and deemed insufficient to mitigate the non-compliance if there are concerns regarding the implementation plan you will be provided with an opportunity to amend the plan and address any concerns identified at the end of the consent period you will be required to provide a submission regarding the compliance of the devices to all of the essential principles okay so now what we're going to do is we're going to have an opportunity to answer some questions one of our team members dipty is going to um ask me some of the questions that are in and hopefully we'll be able to answer some of your questions and like i said any questions that we're not able to get to we can we will follow up sure thank you kate uh so the first question is how will tga police who has consent for non-compliance with essential principle 13a from those sponsors still waiting for manufacturers to finalize their pill will the tga audit peaks and pills sure thanks tipty well all devices can be subject to post-market review and as part of a post-market review or investigation the tga may request evidence of compliance with any of the essential principles so in addition the tga may receive reports from patients or health care professionals that they have not received a pickle pill and in those cases it's very likely that the tga will follow those up with the sponsor to make sure that they're being provided or consent has been sought and what the implementation plan is thank you kate uh our next question is can we supply pill in form of qr code on the retail box sure so um as you might be aware um one of on the 29th of october this year amendments were made to the regulations to allow more flexibility in the way that patient information materials are provided and one of those ways is around electronic pics and pills and the big thing here is that these patient information materials need to be made readily accessible to the patient now given in our new covert world we use qr codes to go to the shops to go to restaurants and supermarkets we would we would say that qr codes are a readily accessible way to information so if the qr code was provided on the box with the device then i'd say that that's a readily accessible way for a patient or a healthcare provider to be able to access the information if that qr code took them directly to that information then i i would agree that that is readily accessible sweet thank you kate next question is are we still permitted to use the tga paper-based performer for the consent for non-compliance or do we need to use the online form in the tbs sponsor portal yeah sure so um yeah you really do need to apply through the tbs portal you might notice that there are additional questions there and information that we require for monitoring implementation plans it's also easier than the paper form so yes on first of december even the consultation hub forms that we have available right now that a lot of people i mean that everyone is using to fill in for their consent for their patient information materials that will also be switched off and all applications will go through tbis and we hope that this is a nice streamlined way to be able to do this we will also have a survey going and we will have a link to the survey from different from the tga website in our guidance document that will step you through all the things that i just took you through and the survey will ask for some feedback because we do have more releases and functionality planned over the coming months to further enhance and integrate the form into the services thank you kate um next question is about the time frame for processing these applications so we have received a lot of questions on that so i'm going to com kind of consolidate into one question sure the question is what is the time frame for processing applications for consent yes and this is a really good question so um we the tga is unable to process any consent applications until the fees are paid in full um so really does depend on the payment type so if you make an immediate payment with your credit card that will kind of expedite things a little bit um if you need an invoice to be raised before you pay then um the tga the standard processing time is around 48 hours of working day so two working days to raise the and send the invoice and then of course um it depends on how long you take to pay the invoice if you pay the immediately as soon as you get it then we need to wait for that money to appear in the tga bank account before the team can go and review the application so really it's the financing just the standard financing and banking thing so we do suggest that you submit your form at least a week or five working days prior to when you would like the consent period to start and we suggest that if time is really important to you that you and you're paying via invoice that you pay that invoice immediately as soon as you get it and if you make a payment on the weekend it's not going to appear perhaps in the tga account till tuesday so um and if you pay after 5 pm it also affects it so really the hold up would be in the payment method that you choose so i give it at least a week sure thank you next question is around the consent application again is there a possibility that the consent will be rejected um the tga will work i mean yes it may not be approved if um i mean the tga wants to work with sponsors so if the information that's provided is not adequate we will contact the sponsor to work with the sponsor to try and get that information now obviously that the back and forth of working with a sponsor may add time onto the application but if evidence is um if they're not able to provide an implementation plan and risk mitigation strategy that would um satisfy uh the requirements that we know um that patients are able to access this information in the interim until fully compliant um devices available then it is a possibility that um the application may not be approved thank you kate uh the next question is do i have to wait for the consent application to be approved before continuing to supply affected devices that do not have compliant patient information materials after one december 2021. yes yes that is a good question so if you want to continue supplying um post one december for devices that are being supplied after one december yes you must have that consent in place so the consent must be in place on or before first of december to ensure a continued supply of the affected devices so that includes the payment of the fees and approval of the delegate of the secretary which then involves the sponsor receiving a notification letter that actually specifies that the consent has been granted if you do not have consent for these non-compliant devices in by this date then you must stop supplying those devices until you have consent in place thank you kate uh next question is is there a time limit for the duration of consent for non-compliant devices how long can we seek consent for sorry sure yeah no that's a good question um so in general consent is usually granted by the delegated secretary for a maximum period of two years however as there's a change in the australian regulations for patient information materials prior to the european union union regulations coming into effect around non-compliant patient information materials then the tga will grant consent for these particular types of applications up until the 25th of may 2024 so that it aligns with the eu regulations so usually two years but for non-compliant patient information materials we will consider up to the 25th of may 2024 thank you kate our next question is uh this is also around the payment uh fees payment so if an invoice is requested by the consent for the consent application how long will it take for the invoice to be raised and sent to the sponsor yes so the turner the standard turnaround time for raising an invoice by the tga is generally two working days so that's important if you're asking for an invoice on a friday after 5 p.m you know you need it's two full working days um the next question is if the tga approves the consent for an application for uh sorry will i need to inform the devices application section that it has been approved or will the consent approval be provided internally to the devices application section yep sure um no there is no need for sponsors to contact devices applications so if the application is has an application for inclusion as one of the devices that are affected then you do not need to inform devices section of your application for consent so the tga processes will ensure that the devices application section are fully informed about the consent application and also the progress of the decision um the the devices application section will be notified when um will be advised once the notification is sent to the sponsor so there's no need for sponsors to contact devices application section in this regard we will let them know a similar question actually a question a subpart of the same question if we have further questions while we are actually applying for a new application then can we contact uh at md consent health.gov.eu yes so if you have any um queries regarding the consent to supply process you can contact us on that email and our team will respond to you for sure thank you kate the next question is if the patient information leaflet is compliant but the patient information card peak is not can we seek consent for non-compliant pigs only yes definitely so sponsors can seek consent for non-compliant picks only by selecting that specific essential principle within the that's related to picks within the application form and conversely if it's you need consent for non-compliant pills then you just select that essential principles um within the application so yes you can do it for pick only or pill only it doesn't matter you're just selecting this entry principle and of course if it's for devices that are non-compliant with both then you can select both thank you kate our next question is do i need to apply for consent if the manufacturer plans to release the devices with patient implant cards and patient information leaflets from 1 december 2021 from their site no so if the patient information materials for those devices will be compliant on one december when the devices are actually supplied then consent for non-compliance is not required sure thank you i think uh we should wrap up the question answer session now and we'll answer we'll try to reach out to all the sponsors or all the questions that we have received so far over to you okay back again thanks um okay thank you so much for uh joining us today like i said um we hope to have the new form up on wednesday uh in tb's and um this will be the first release of a number of releases as we look to improve the form and as i said before there will be a guidance document that steps you through filling in this form available on the tga website on the essential essentials principles non-compliance page and we also have frequently asked questions document up there too that will take you through some of the common questions that people have so you can have a read of that um and like i said yeah we will have a look at any more of the remaining questions that have been provided today and we will try to get back to everyone with answers to your questions