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- Presented by: Petra Bismire, Therapeutic Goods Administration
- Presented at: Online webinar
- Presentation date: Tuesday 23 November 2021
- Presentation summary: Explaining how medical practitioners can apply to access certain medicinal cannabis medicines via the Authorised Prescriber Established History of use pathway (no ethics committee approval required) and guide you through applying to prescribe 'unapproved' medicinal cannabis products by category of active ingredient.
- Presentation: Medicinal cannabis – Changes to Special Access Scheme (SAS) and Authorised Prescriber applications (pdf,1.01Mb)
Recording of online webinar
Good afternoon, everyone, and thanks so much for joining us for this afternoon's presentation on changes to medicinal cannabis special access scheme and authorised prescriber applications.
I'd like to start by acknowledging the traditional owners and custodians of the lands on which we're meeting today. For those of us here in Canberra, that's the Ngunnawal people. But I'd like to acknowledge that we're meeting across a large number of lands today and acknowledge all the elders, past, present, and emerging in various lands. I'd also like to extend that acknowledgement and respect to any Aboriginal and Torres Strait Island people that we have here today.
So, again, thanks for joining us. [Unclear] has introduced me already. My name is Petra Bismire. I am the director of the experimental product section. So, we're the section that looks after access to unapproved goods or goods that aren't included in the Australian Register of Therapeutic Goods. And that's mainly through the special access scheme and authorised prescriber scheme.
So, in today's session, I'll explain the key changes that we've made in order to reduce administrative burden for prescribers. So, I'll introduce you to five active ingredient categories for special access scheme and authorised prescriber applications for medicinal cannabis.
I'll outline the addition of certain medicinal cannabis medicines into the authorised prescriber established history of use pathway. And I'll also give you a walkthrough of how to apply via the online system.
So, the key points in terms of what's changed. The approvals from yesterday are no longer granted for a specific product or brand, but by active ingredient. The approvals will remain specific to dosage form and indication, however.
Again, some cannabis medicines have been included in the authorised prescriber established history of use list, which means no ethics committee approval is required in order to become an authorised prescriber. And to support healthcare professionals in prescribing, we'll be publishing a list of available products on the TGA website.
So, I'll start with our decision to move to SAS and authorised prescriber applications by active ingredient. And these changes have been made in order to reduce the administrative burden for prescribers who we're aware had to reapply for new product specific TGA approvals quite frequently due to stock shortages and discontinuations, name changes, all of which, unfortunately, are common in this industry.
So, the new approvals by active ingredient will reduce the administrative burden for prescribers who no longer require a separate approval for their patient if a specific branded product, for example, is out of stock or is suddenly discontinued.
So, while approvals are no longer granted for a specific product or brand, we do recognise the complexity of the cannabinoid content of medicinal cannabis products. And so, to account for this, we're allowing submissions on the basis of broad category of cannabinoid content.
The approvals will remain specific to dosage form and to indication. But the change means that prescribers can obtain approval for a category, and then issue prescriptions for any product within that category without the need to reapply for TGA approval each time. And ultimately, our goal is to improve patient access for appropriate patients.
So, here, I've included a list of the five categories that we'll be using moving forward. Hopefully, you can see that clearly on your screen. But as you can see from the column on the right, all of these categories are framed around cannabidiol content of the medicine. So, for example, category one medicines meet the schedule for prescription-only definition, as laid out in the poison schedule or SUSMP.
And these products are comprised of 98% or more of cannabidiol included in the total cannabinoid content of the medicine, any cannabinoids other than cannabidiol in the medicine, only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine, and if the medicine contains no other active ingredients.
Category two products are what we're naming CBD-dominant medicinal cannabis products. These won't meet the schedule four definitions. These are schedule eight products, that are dominant in CBD. So, these products are between 60% and 98% cannabidiol or CBD, with the remaining cannabinoid content being made up of other cannabinoids, which may include THC.
Category three products are what we're calling balanced medicinal cannabis products. So, in general, they will be approximately 50/50 THC, CBD. But the definition here is that the product is made up of between 40% and 60% CBD, with the remaining cannabinoid content being made up of other cannabinoids other than cannabidiol, and that may include THC.
So, for category four and five products, we've named them THC-dominant medicinal cannabis products and THC medicinal cannabis products, in recognition of the fact that we expect that most of these products will be THC dominant. But the system does allow flexibility for products which are dominant in another cannabinoid.
So, if you look at the definition here, a category four medicinal cannabis product is a product which contains between 2% and 40% cannabidiol, and the remaining cannabinoid content is made up of other cannabinoids, which we expect is likely to be THC.
And the last category, category five medicinal cannabis products, essentially, we're calling them THC medicinal cannabis products. If you look at the definition, they contain between 0% and 2% cannabidiol. The remaining content is made up of other cannabinoids, which may be up to 100% THC.
So, hopefully, that explains the five categories. This list is available on our website, if you go to the medicinal cannabis hub of the TGA website. And if you have trouble getting there, you can just Google medicinal cannabis… Sorry, not Google. You should search medicinal cannabis on the TGA website. That'll take you to the medicinal cannabis hub. And from there, you can select the option for healthcare professionals, and you can find a host of information in there, including this useful tool.
I should mention, we are also publishing on the TGA website a list of products which are available under each of those categories, just in recognition of the fact that there is some complexity there. So, sponsors will be declaring to us what category their products fall in, and we'll be publishing those products on the TGA website to assist prescribers and pharmacists.
Another big change we're introducing is inclusion of certain medicinal cannabis medicines in the authorised prescriber established history of use pathway. And so, these are included in this pathway by reference to the active ingredient category, the dosage form, and their indication.
When using this pathway, approval from a human research ethics committee or specialist college endorsement is not required before applying to the TGA to become an authorised prescriber of these products.
So, it's important to note that only medical practitioners can apply to become an authorised prescriber. Other prescribers, like nurse practitioners, may still apply via the SAS Category B pathway, but this pathway is only open to medical practitioners.
And the advantage of becoming an authorised prescriber is that an authorised prescriber can prescribe... Once they become an authorised prescriber for a particular medicine, for a particular dosage form, in a particular indication, they can prescribe to patients under their direct care without the need for separate approvals for individual patients. Unlike SAS B, where a different medicinal cannabis... Sorry, I'm just getting distracted by the chat.
If people could please kindly hold their questions until the Q&A function at the end, that would be appreciated. I'll run through as much of the content as I can, and then I'll pause for questions. And if you use the Q&A tool, that will become available, and we'll do our best to answer as many of those questions as we can.
So, authorised prescribers are able just to prescribe as much as they like once they become an authorised prescriber, without the need to apply to the TGA every time, unlike the SAS Category B pathway. That's fine, Rachel. That's fine. [Unclear]. Thank you. That's fine.
So, as you can see here on the screen, I've included the products which are included in the authorised prescriber established history of use list. So, that's category one, two, and three products.
So, category one products have been included for the dosage form liquid and capsule, and for the indications chronic pain and anxiety. Category two products are also included for liquid and capsule, and for the treatment of refractory chronic pain in adult patients, or the treatment of refractory anxiety in adult patients. Category three, or balanced products, have been included for liquid and capsules, in the treatment of refractory chronic pain in adult patients.
So, if, for example, a doctor wanted to prescribe products under these categories, they can apply that directly via the TGA portal, which I'll show you through next, without the need to get ethics committee approval beforehand. And there are no restrictions around what doctors can apply, or how many SAS B applications you have to have done. Any Australian medical practitioner can apply to become an authorised prescriber of these particular products.
Authorised prescribers do, however, have to inform us of how many patients they treated during a six-month period, and those six-month periods are defined periods. So, from January until June, and from July until December. And reports have to be submitted within one month of the recording period closing.
I'll do a walkthrough of the applications, of how to submit an application to become an authorised prescriber towards the end of the presentation. But if, for example, a prescriber wanted to become an authorised prescriber of one of these products for a different indication, or a different dosage form, or for a category four or five product, they would have to either get ethics committee approval, or apply via the SAS B pathway as normal.
So, I've outlined here on this screen some of the decision framework around… A flow diagram of how to make a decision as to which pathway to use. And as I mentioned, the authorised prescriber route is only available for Australian registered medical practitioners. Other prescribers, such as nurse practitioners, may be able to use the SAS B pathway. And importantly, authorised prescriber applications must be submitted by the applying medical practitioner themselves.
These tools are intended for doctors who've already made a decision to use a medicinal cannabis product. And I'd just point out here, too, that unapproved medicines are not assessed by the TGA for quality, safety, and efficacy. And the medical legal liability for use of an unapproved good lies with the approval holder of the prescriber.
So, you must have considered the use of approved and available treatments appropriate for the condition prior to the decision to use an unapproved good. And you should check whether your prescribing intentions made the authorised prescriber history list that I had up earlier.
So, for example, some prescribers might use the category, and then look on the TGA website to find the corresponding products that are available, that they wish to prescribe, while others might do it the other way around. They may know which product they wish to prescribe, but not know what category that fits into.
So, after you've decided that a medicinal cannabis product is right for your patient, select a medicine that's clinically suitable for your patient, and you may wish to refer to that published list of medicinal cannabis products that I mentioned, under the five active ingredient categories. If the active ingredient, and dosage form, and indication is included on that list exactly, then you can apply directly to the TGA to become an authorised prescriber.
Approval is generally provided for five years. And you can then write prescriptions that would detail more information than just the category. Prescriptions should include active ingredients, strengths, dosage form, and whatever other information you think is necessary to enable the pharmacist to choose the correct product. You may, if you wanted to, if it was clinically necessary, you may include the trade name, but this is a decision at the discretion of the prescriber, and this is no different to prescribing any other good once you've received TGA approval.
If the product isn't included on the established history of use list, you may submit a SAS Category B application, or you could obtain approval from a HREC, and then apply to TGA to become an authorised prescriber.
I thought I'd show you what the TGA approval letters will look like, under the authorised prescriber and special access scheme pathways. So, as you can see here, rather than the trade name that you might be familiar with seeing, instead we've got the category of product here. So, here, we've got a category one CBD product, that's for refractory anxiety in adult patients.
On the SAS letter, we have the same thing. We have the category one CBD medicinal cannabis product for a particular patient, and again in the indication anxiety.
And so, as I've mentioned, the next step then is to write a prescription, and you'll need to put more information on your prescription in terms of what product you wish to prescribe. But to assist you with that, we'll be publishing a list on the TGA website with the number of products that are available in those categories.
In terms of generic substitution, this is no different from any other medicine. So, a pharmacist may wish to substitute a medicine if they think it's clinically appropriate to, and that may require consultation with a doctor if it's necessary.
So, for example, if the prescription doesn't contain enough information to identify a particular product, they may wish to contact the doctor either to request a new prescription or clarify the prescription. If a new prescription is required, that would just be negotiated between the pharmacist and the doctor, and there's no need then to go back to the TGA for further approval. And that's been outlined here on this infographic.
So, the move to issue special access scheme and authorised prescriber approvals by the category of active ingredient is designed to reduce administrative burden and provide flexibility for prescribers. And again, it's to account for frequent product name changes and product shortages without needing a new SAS or authorised prescriber approval letter each time.
So, the five broad categories of active ingredient that I outlined earlier is what you receive the approval for. However, it's expected that the prescriber includes enough detail in the prescription that the pharmacist can identify a product to be selected.
So, generally, a prescription should include active ingredient, name, strength, dosing information, quantity. Inclusion of a brand name may be included if the prescriber feels that's clinically relevant.
And as for any other prescription pharmacist decision regarding substitute brands, or whether any prescription is required, need to be made in accordance with normal practice. May include consultation with the patient and prescriber.
And prescription law falls under the remit of states and territories. So, if there are any questions regarding what's required on a prescription by law, those should be directed to your relevant jurisdiction. We do have contact details for the states and territories available on the TGA website.
I just want to take a moment here to mention reporting of side effects. So, we strongly encourage healthcare professionals to report any suspected side effects that are related to medicinal cannabis products, or any medicine that they're using. Reporting of side effects and problems helps us to understand the safety of a product, and we investigate significant safety concerns as part of ensuring product safety in the Australian community.
There are multiple ways in which adverse events and defects can be reported to the TGA, but the preferred reporting route is via the TGA website.
So, next, I'll take you through how to apply. Our preferred application route is via the SAS and authorised prescriber online system. This helps reduce administrative burden at our end and helps speed up the rate at which we can approve applications. It also is intended to reduce the administrative burden of prescribers. There are a number of features that exist. So, for example, for SAS B applications, if state or territory approval is required, that can be applied for in the same application form, and I'll take you through that now.
For authorised prescribers, there's [unclear] using the online system, in that you can do your six-monthly reporting via the online portal. And we can send out reminders to you via the online portal. If you become an authorised prescriber for a particular product, even if you don't treat any patients during that time, you still have to report to us the number of patients treated is zero.
I've included the link here for how to use the portal. But I'll share my screen with you now, so that you can have a bit of a walkthrough system looks like. The first step will be to follow the link that was just included on this slide. That will take you to the regulatory and compliance portal, where you'll need to select the special access scheme. So, this button is also used to become an authorised prescriber. We're looking at having this updated, and in the near future, to say special access scheme and authorised prescriber.
This will take you to the welcome page. Along the top here, you can see a few different dashboards. So, to submit a SAS application, you'd use the SAS dashboard. And to submit an authorised prescriber application, you'd select the authorised prescriber dashboard.
So, I'll take us now through an example application of how to become an authorised prescriber. And as I mentioned, any Australian registered medical practitioner can become an authorised prescriber.
So, you'll go to the authorised prescriber dashboard, where you'll see on your dashboard history of products that you've applied for. And you can also see down here further details, including finding or copying an application.
So, I'll be selecting a new authorised prescriber application, and the first step is prescriber details. So, this information is filled out from your registration information, and there's also an option here to change your email address and phone number if those have differed from the information that you provided at the time of registration.
So, the next step is to choose the type of therapeutic good that you'll be prescribing. In our case, since we're doing a medicinal cannabis application, we'll choose medicine. And we'll have a look here to see if our medicine is included in the established history of use list.
Medicinal cannabis products are included on the final page, and you can see here they are included by active ingredient category or circumstance. So, category one medicinal cannabis product is one in which cannabidiol compromises 98% or more of the total cannabinoid content, and the medicine contains no other active ingredients, and today I wanted to treat a patient who has chronic pain or a class of patients who have chronic pain. So, the code for that is AP131.
So, yes, my product is included in the established history of use list. And here, I'll choose my active ingredient name. I find it easiest to use the wild card or the asterisk, as that helps us find parts of names. And I'll include cannabis, so that maybe those relevant options are brought up. Here, we can see the established history of use category one medicinal cannabis products have been included, so I'll select this option.
And the available dosage forms are capsule and oral liquid. I'll be using oral liquids, so I'll choose that option. If you know information about the product's strength, or trade name, or sponsor or supplier, you're welcome to include that information, but that's not mandatory. As you can see here, mandatory information is indicated by the red asterisk. And if you wanted to upload any additional information, you could do so.
I'll save and move on to the next step, which is the indication. So, it's important that you include the indication exactly as specified on the list. We do have intentions of updating the online system so that this is pre-filled. But at the moment, you'll just have to fill in the indication. [Unclear]. Refractory chronic [unclear] patients. Save and next.
And that takes you to the fourth step, which is just a summary of your application, so you can double check it. A review of the privacy information, and an agreement that you've read and understood the privacy statement, and you press submit.
So, as you can see, the application process itself is very simple for those products that are included on the authorised prescriber established history of use list. And you can see the status of your application here, on the authorised prescriber dashboard. So, you can see here that my application is under TGA review. And in general, we try and approve these applications within five to seven days.
In the meantime, if you have someone that needs to be treated more urgently, of course, you can always use the special access scheme pathway, and those applications are reviewed within two working days of receipt.
I'm trying to show you the six-monthly reporting, but unfortunately I can't see that any of these applications have been approved. But the six-monthly reporting is available when an application has been approved, by using this dropdown menu here. There is further information available on our website.
So, in order to submit a SAS application. If, for example, your product didn't meet the authorised prescriber established history of use list, or if it was for a different indication or dosage form, or if you're not a medical practitioner, if you're a nurse prescriber, for example, you could use the SAS Category B pathway.
So, you go to the SAS dashboard and select new submission. The first step asks you whether you'd like to share the submission. So, this is a function that's available for people who work in a clinic, for example, a medical practice, where there are multiple prescribers, and you'd like to share and view one another's application. So, you can have your site included as an affiliated site, and you could share your application with affiliated sites, to share with other health practitioners within that site.
So, the first question is, are you the prescriber? And for medicinal cannabis applications, we do require the application to be made by the prescriber themselves.
Next, you'll save that step. Again, you could change any of that information if that's changed since the time of registration. Again, we'll be selecting a medicine, and we'll be selecting an active ingredient. Again, I'll use that wild card function. And this time, I'll be using category three, balanced medicinal cannabis product. And the dosage form, I'll be using the oral liquid. And I'm wanting to use this in cancer pain and symptom management.
The next question asks you whether you need to apply to the state or territory. So, this is a decision that needs to be made. Prescribers need to understand the requirements of the state in which they're operating. If you have any questions, if you're unsure as to whether you require additional state or territory approval, I recommend you get in touch with your state or territory health department, and contact details are available on the TGA website for that.
So, I'll select, yes, I do need to notify state or territory, and that state or territory might be Victoria. The last question on this page asks you whether you wish to submit a category A notification rather than a category B application. And in general, it is easier for medicinal cannabis products to apply under the category B pathway, even if your patient needs the category A definition.
And the reason for that is that products must be imported on a case-by-case basis for use under category A pathway, and that's a requirement of legislation under the Narcotic Drugs Act. So, in general, it's faster and easier to use the category B pathway for medicinal cannabis products.
I'll say, no, I don't wish to submit a category A notification. And here, I'll include information such as the dosage form. Sorry, the dosage frequency. And again, if you know information about the trade name, or sponsors or supplier that you'll be using, you can include that there. However, that's not mandatory. And the intended date of supply will be on Friday.
You'll notice there that the duration that's pre-filled in is 24 months. So, in general, SAS B applications are approved for 24 months. And if prescribers wish to include further restrictions, they can do so on their prescription, but it means that you don't have to go back to the TGA for approval so often.
So, here, I'll include the next step. The fourth step is for patient details. So, I'll include information on my patient, including their initials, and some identifying… Their date of birth. Their gender. If you're working in a hospital, and you know their MRN, you could include that. If they had a previous SAS number, you could include that. And the diagnosis. Cancer pain.
Clinical justification. So, clinical justification just needs to demonstrate to the delegate approving the application that you've considered other ARTG-approved goods before submitting an application to the TGA to use an unapproved good. So, that might include a list of some products that you've tried or considered trying, that weren't appropriate for that patient. Just enough information that the delegate can see that you've considered other ARTG-registered goods before considering the use of an unapproved or experimental product.
And we'll also ask for some details of monitoring. So, for example, for this patient, you may deem that they need to be followed up every two weeks, for the first month, and then monthly after that, or whatever you deem is appropriate for your patient, in their clinical circumstances.
The fifth part of the form is the state-specific part of the form. So, this is where the state requires some additional information. So, you'll include further information. So, this state, for example, Victoria, requires details of names rather than just initials. So, we'd include [unclear]. And you'll need to include your prescriber qualifications, and whether you have any supporting information. Again, this is information that the TGA doesn't see, which is specific to the state or territory in which you're applying.
And that then takes us to the last page, which, again, is a summary of your application and a requirement to read the privacy statement and consent, and if you've understood that before submitting the application.
So, as you can see, the SAS, there is definitely advantage in becoming an authorised prescriber if the product is included on the established history of use. The process is much simpler for those products, and you don't need to apply for every patient. So, where can you go for additional support? So, we've updated our web pages. So, I mentioned the cannabis hub earlier. That can be found on the TGA website.
And we've got a specific page which includes information for health professionals. So, we've updated that page, as well as the page for information for sponsors and manufacturers.
And we've also created a number of support tools. So, the description of the active ingredient categories, which is the one I showed you earlier today. The list of medicinal cannabis products by category of active ingredient. That's, again, included on the TGA website. And the authorised prescriber scheme list of medicines with established history of use that I showed you just now.
We've also updated a number of guidance documents. So, that's the authorised prescriber scheme guidance document. The online system guidance document for both special access scheme and authorised prescriber scheme. And we'll also be making slides from this webinar available.
Okay, so now we'll stop for questions. So, please, if you have any questions, submit them via the live poll. I also have a couple of pre-submitted questions that I can go through. So, thank you for your time, and bear with me while we have a look at the questions that have been submitted. Thanks, everyone, for your time. My colleague Senthil Lingaratnam [?] is going to read some of the questions that have been submitted.
Thanks, Petra. Seems to be a lot of questions regarding what is appropriate to write on a prescription, and whether brand substitution is allowed for the pharmacist. So, Petra, if you want to clarify.
Yes. Sure. I might take us back to this useful infographic that we had. So, as I mentioned, a script should include active ingredient name, strength, dosing amount, frequency, quantity of the medication, and number of repeats. So, this is no different to any other prescription.
So, once you've received TGA approval for a category of medication, what goes on a prescription is no different from any other prescription. So, you may wish to include the brand name, if you think that's clinically appropriate, or if you think it's going to be necessary to help the pharmacist choose the correct product.
In terms of generic substitution, that should just be done in accordance with normal practice. So, for example, if a product was ten milligrams per ml CBD, and ten milligrams per ml THC, there may be two brands that are available there. Provided that the doctor hadn't ticked the box that says, no generic substitution, it would seem to me to be appropriate to substitute those brands.
But again, these decisions are decisions that are made at the discretion of the individual clinicians, in accordance with pharmacy board guidelines, or medical practitioner board guidelines.
And I guess if there were any concerns about the prescription being incomplete, then a pharmacist could call the doctor and clarify. If a new prescription was needed, a new prescription could be issued. It just simply means that you don't need to come back to the TGA to ask us for a new approval to use a specific brand of a product.
Great. Thanks, Petra. There are a few questions in regards to authorised prescriber, and what these changes mean to their approval for their current trade name product. I'm wondering if you could clarify that.
Yes, that's a great question. Thank you. So, if you're an authorised prescriber for particular products, and likewise with SAS applications, those approval letters hold valid for the duration of approval that's dictated on that approval letter. However, if you want to substitute for different brands, or rather write prescriptions for different products, you may wish to become an authorised prescriber or obtain a SAS approval for the active ingredient category, and that can be done from today.
I just want to point out that the walkthrough that I just gave you now is in a live environment. It was a test login, obviously. But what you saw there is what's available on the portal currently. So, those applications can be made from today, just as I did in the example walkthrough.
Great. Thanks, Petra. There are a few questions in regards to compounding, and whether the changes affect extemporaneous compounding by pharmacists.
Thanks. That's a good question. So, at the moment, there are no changes to extemporaneous compounding.
However, there was, you may remember, a public consultation in January of this year, where we consulted on extemporaneous compounding. And we're likely to see changes to extemporaneous compounding from next year. Hopefully, early next year. Which will require SAS or authorised prescriber approval in order to extemporaneously compound.
Great. Thanks, Petra. There's a question in regards to schedule three medicinal cannabis products. I just wonder if you could clarify.
Thanks. Yes, that's a great question. So, some of you may be aware that certain cannabidiol, certain low dose cannabidiol products were included in schedule three, pharmacist only, of the poison standard earlier this year.
However, it's important to note that those products were only included in schedule three if they're included in the ARTG, in the Australian Register of Therapeutic Goods. Meaning that they've been assessed by the TGA for safety, quality, and efficacy. And unfortunately, at this stage, we don't have a single product that's included… A single low dose cannabidiol product that's included in the ARTG.
So, unfortunately, we don't have any schedule three products at this stage. However, we are encouraging sponsors to submit applications to the TGA to register their products. That's an ongoing exercise.
Great. Thanks, Petra. There's a question here in regards to existing SAS B approvals for individual brands. Do we need to resubmit SAS B applications to transition to categories instead? Or will this be done automatically?
Great. Thank you. So, you can continue to use your SAS B approval for a particular product, but you can only use it for that particular product. If you want to use other products, I recommend applying for a generic approval, so that you can use multiple products within that category without the need to come back to the TGA for approval.
Wonderful. Thanks, Petra. There are also a few questions regarding applying for various routes administration or dosage forms within the same category. I'm just wondering if you could clarify if that's possible? Or AP applications.
Great. Thanks. So, for authorised prescriber applications, if you remember the codes that I showed you on that form, they need to be applied for separately. So, authorised prescriber applications will need to be made for one category, for one dosage form, but you can include the two indications. So, for example, you could apply for category one products for oral oil for chronic pain and anxiety, and then you could also apply it separately for category one products for capsules for chronic pain and for anxiety in the one application form.
Category three products. Again, they're all specific to dosage form. So, you will need to do a different authorised prescriber application for different dosage forms.
Thanks, Petra. There are also a few questions in regards to specific state and territory applications. Do you want to clarify what the requirements are in terms of AP, as well as SAS B?
Yes. Sure. So, if you're applying via the SAS B route, you can submit your application to relevant state or territory health department in the same application. But if you're using the authorised prescriber pathway, you'll need to apply directly to the state or territory for approval from them.
In terms of the individual requirements. TGA can't comment on the requirements of individual states and territories. So, we recommend you to get in touch with your relevant state or territory health department in order to clarify any of the requirements as to whether additional approval is required to prescribe medicinal cannabis in your jurisdiction. It's the responsibility of the prescribing health practitioner to know the legislation of the jurisdiction in which they are operating.
Thanks, Petra. We've had a pretty similar question as well, in regards to using the paper form. Just wonder if you could clarify whether that paper form is still available for prescribers.
Yes. Great. Thanks for the question. So, we will still accept paper applications. The online submission of SAS and authorised prescriber applications via the online system is preferred in order to reduce processing times. So, the paper forms are still available on the website for exceptional circumstances. So, for example, where the medical practitioner is unable to use the online system.
And our staff will be providing education to prescribers who wish to use the paper form in regard to applying for active ingredient category as opposed to a specific trade name.
Thanks, Petra. We've got an interesting question here in regards to prescribing under AP for paediatric patients. Whether there are any steps that are different in the SAS online system for under 18s.
Thanks. That's a great question. So, as you saw from the indications that were included in the authorised prescriber established history of use list, these are only for adult patients. So, if you wish to use any medicinal cannabis product for a paediatric patient, you need to become an authorised prescriber. You'll need to get an ethics committee approval. Otherwise, you could use the SAS B pathway.
All right. Thanks, Petra. There are a few questions coming through about the AP scheme and whether particular courses need to be done prior to applying.
No. So, any Australia registered medical practitioner can apply to become an authorised prescriber, and the application process is exactly what I showed you just now. So, these particular medicines for those specified dosage forms and those specified indications have been deemed to have established history of use by the TGA and can be used without ethics committee approval.
If the product doesn't meet those requirements exactly, then you'll need to apply for ethics committee approval to become an authorised prescriber, and depending on the HREC or ethics committee, they may require certain courses. I'm not sure that's within the remit of that particular ethics committee.
Thanks. And on that topic, Petra, someone has asked about the six-monthly reporting for under AP, and the requirements, and why it's considered necessary.
So, because we're not receiving applications on a per-patient basis, we do wish to still collect information about the number of products that are being used in Australia. As a condition of the approval, we do require six-monthly reports to be provided. And this is a requirement, actually, under subregulation 12B of the Therapeutic Goods Regulations.
Authorised prescribers are required to submit to us every six months just the numbers of patients that were treated. The information is fairly simple. They're just raw numbers. So, for example, you would say, I started four new patients on this medication, during this particular six-month period, and I continued to treat another two. So, the total there is six patients treated during that six-month period. But we're just looking for whole numbers. We're not after dates of birth or patient details or anything similar.
Thanks, Petra. Going back to a pre-submitted question. How will quality requirements for importers be enforced with the new changes to the scheme?
The sponsors of medicinal cannabis products continue to be legally responsible for ensuring that their products comply with TGO 93, as well as other relevant orders. TGO 93 isn't the only relevant order.
For example, there's TGO 100, which is the microbiological order. They're just no longer required to submit a TGO 93 declaration form to us, and that's no different from any other orders. We don't require a declaration form, but the sponsor is legally obliged to comply with these orders.
And we do do compliance audits. So, for example, our laboratories run targeted and random laboratory testing, and that's to assess that the content that's declared on the label of active ingredient is correct, as per the stated claims. And we also have done tests for toxins and impurities.
And of course, failure to comply with TGO 93 or any other order is subject to regulatory compliance actions. So, that includes civil and criminal penalties, under sections 14 of the act. Sponsors also have a six-monthly reporting requirement. So, like authorised prescribers, they must report to the TGA the numbers of products that they used, and under which pathway, every six months.
We've introduced a new form that's an existing requirement. We've introduced a new form to streamline that process for them. And so, we're expanding our compliance framework. So, despite removing the declaration form, we're expanding compliance measures.
So, there's a question here about whether products are required to be manufactured in accordance with GMP. So, again, this is something that was part of the public consultation that was held in January of this year, and changes are coming into place likely from March next year, to require GMP for imported products.
Currently, GMP is required for Australian domestic products, but not for imported products. And so, these changes are being brought in to level the playing field and require GMP for imported products. And those changes are likely to be in place from March next year.
Thank you. There seems to be a question in regards to the SAS Category C application pathway. Do you mind clarifying the SAS? Thank you.
Sure. So, SAS Category C is a notification pathway, which is for products which have established history of use. So, it is similar in some ways to the authorised prescriber established history of use list. SAS C is only available under our regulations for our schedule four products.
So, we haven't included medicinal cannabis on any of this, on the SAS C list. And SAS C notifications need to be provided on a per-patient basis. Whereas authorised prescriber scheme, as outlined, someone can just become an authorised prescriber of a particular product, and then prescribe that product as much as they like within the period of the approval. So, the authorised prescriber pathway is much more streamlined and much better for medical practitioners in our view.
Thanks, Petra. There is a question here about writing an AP prescription prior to authority. Do you mind just clarifying?
Sure. So, in Australia, products have to be included in ARTG in order to be supplied in Australia. There are exemptions to this, and authorised prescriber and SAS are some of those exemptions. So, it's illegal to write a prescription for a product that you don't hold an AP or SAS approval for.
You got a question here. When can we expect to see the published list of products within each category? So, we're expecting that that list will be available on the website hopefully today or tomorrow. We're just reviewing that list, unfortunately, for compliance with legislation before we publish that. So, we are working on that as quickly as we can.
I think that's all we have time for today. I'm sorry that we weren't able to get through all of the questions, but I think we did get through the lion's share of them. If we didn't answer your question, or if you have any further questions, please do feel free to contact us at firstname.lastname@example.org.
And thanks, everyone, for joining us this afternoon. I know how busy prescribers and pharmacists are. So, really appreciate you taking time out of your lunch break or day to check in and learn about these important changes, which hopefully will reduce administrative burden for prescribers.