HighIQ Webinar Series: Preparing your product for the EU Market

GrowerIQ & LEF/Infosaude join forces to advise on all things about preparing your product for the EU market

We are so thrilled to be working alongside the incredible team from the labs at LEF/Infosaude, that we thought it would be a great opportunity to get together and share some handy tips to help your team expand your business into the EU.

The event will take place on Monday, December 12, 2022 at 11am EST for all those who would like to attend!

We will be joining together to discuss:

• Preparing your product for the EU market
• Specifications that must be filled to sell in the EU
• How to market your product in the EU
• Testing your product for the EU market
• Tracking: how GrowerIQ logs samples, COAs (certificates of analysis), releasing a batch & more.

Join our very own Rob Perry, Vegar Samuelson, and Sara Figueiredo from LEF/Infosaúde, to get all of your questions answered.

Transcript:

Rob Perry  0:07  

Hello, everybody, I just wanted to reach out. And thank you for joining the GrowerIQ, HighIQ webinar. This is the HighIQ webinar is it's an activity that we do, we try to do it every few months, where we bring in some of our peers in the industry or partner groups and just tried to address topics that are relevant to people in the cannabis industry these days, address questions that we're hearing from customers virus or other people out in the markets and really just try to share a little bit of, of knowledge as we go through. So today we're connecting with left in Sodo. They're an organization based in Lisbon in Portugal. And we've been partnered with them for a couple of years. And they provide and they have been providing cannabis testing, regulatory advice and other consulting support to companies in Portugal and Europe. And companies looking to get their product into Portugal in Europe, too, to support that market. It's a fantastic company. You know, they have a really, really great modern and extensive facility just outside of Lisbon, where you know, where they do their work to support to support the market. So, you know, very excited to have Sarah with us today to talk through and share some of some of her experiences. Just a quick run-through on the agenda. We're going to move to Sara first. And she's going to take us through a presentation that she's preparing. Then we're going to jump over to Vegar from GrowerIQ. And we're going to just have a have a quick look at how some of this is relevant in the broader IQ platform before we move back to questions and answers. And, you know, we'll try to spend, spend about 15 minutes on that. If we don't get to your question. Yeah, please feel free to reach out to one of us afterwards. But we'll be we'll be monitoring the chat. We have some questions from before. So we'll we'll hopefully be able to address everything. So Sarah, thank you. Thank you very much for joining us. And, you know, please, please take it away. Thank you.

Sara Figueiredo  3:02  

So can you see the slides? We can thank you. Okay, so let's go. So good afternoon, everyone. I would like to welcome you today. First of all, I would like to congratulate the Organising Committee of these AI HighIQ webinars, preparing your product for European Union markets. Before I start, I would like to quickly introduce myself. My name is saya figurado. And I'm a pharmacist with professional experience in the fields of the quality control and stability in pharmaceutical industry. I'm currently in charge of the introduction of new products and microbiological control departments at Lef in which all analytical activities in the scope of medical cannabis are carried out. So let's go ahead with the presentation based on the quality requirements applicable to cannabis products, particularly real relevance for the commercialization in European Union markets. During my talk, I will provide you some background on the topics listed in the slides. In the first chapter of this presentation, I will address some concept to frame this subject but first, I would like to give you a brief disclaimer. This presentation is based on the curate guidelines knowledge and experience of flaps in fursuits. Therefore, modifications on regulatory framework may or can modify the applicability of the contents of this presentation. Well f is a GMP and GLP-compliant CRO and CMO providing a wide range of services like quality consultancy pharmaceutical development, production, analytical services and Regulatory Affairs. And pharmacovigilance in the pharmaceutical sectors as well as in other sectors. We are composed of 2400 square meters of GMP Food Lab for physical, chemical and microbiological testing of drug products, as well as a pilot scale unit to for the development and the production of non-sterile solid, semi-solids and liquids, products. We are composed of a multidisciplinary team from different areas such as pharmacies by technology, biochemistry, chemical engineer, among others, we are about 75 employees in which more or less 80% with a university degree we have three qualified persons one regulatory affairs specialist and one toxicological experts. As well we know the cannabis plant is referring for flowering plants in which there are three main species Cannabis sativa Cannabis indica also cannabis ruderalis we will focus on the cannabis sativa issues plants that can have both female and male flowers. In fact, the only the family of plants of cannabis sativa are used for medicine or proposes femoral from cannabis sativa reach a higher dimension with a greater amount of cannabinoids, particularly in the flowers and the top leafs. As all we know that cannabis sativa is made of hundreds of chemical compounds like cannabinoids, terpenes, flavonoids, sugars, I drew carbons among others, which are found in the flowers, leafs but extracts from the plant among others. In fact, the most studied cannabinoids are THC, CBD and CBN. And they can present different amounts depending on the variety of the species of the plants, in fact each strain as a unique profiles of the chemical compounds like cannabinoids, terpenes and floodlights. Moreover, there are other minor cannabinoids like CBC or CBG that are largely non psychoactive and have active ingredients that can have other beneficial effects for the treatment of different pathology on the framework, the regulatory framework in Portugal in fact, the decree of 2090 as supports the use of the substance preparation and herbal medicine are products based on cannabis plants for the relief for the symptomatic relief and also the treatment of a specific pathology like nausea, glaucoma, chronic pain and so on. So, we have it can include not only the herbal medicinal products like if your legs are Sativex, but also some preparations that are substance we in which an additional treatment was is applied and also the substances basis based on the cannabis plant that includes not only the plants but also parts they're off whether will or fragmented in wish no additional treatment is applied. As all we know probably in Portugal there was one one product approved for national market from from the company at shield right. Now, we will talk about the quality system in pharmaceutical industry. In fact the quality assurance system in pharmaceutical industry or the main proposal of the system is to guarantee that the medicines being manufactured, fulfilled will or promotes the desired effects in the patient. Therefore, it is really important that the system guarantee the quality the safety and efficacy of the product when why when we talk about the medicinal cannabis product, it is really important that the quality system ensure the quality and the safety or in other words that each medicine is safe, effective and of standard quality. In fact, it is really important that this quality system ensured that the The medicines being manufactured will meet all quality requirements and of course all the relevant regulations. In the scope it is really important to note that there are requirements from GCP guidelines that must be followed in during the entire process by applicant entities. For instance, for license to for the cultivation of medicines for me for based on cannabis for medicinal proposes, it is really important to follow the grid agriculture and collection practices GA CP published by European medicine agency, when we talk about the license to manufacture the substance preparations or herbal medicinal products based on cannabis plants for Medicinal Products must be followed the good manufacturing practices GMP part one or part two depending on the steps of the process, and good distribution practices must be followed in the cases of the distribution of these type of substances. It is important to note that the evaluation of the compliance with the GX EP will be carried out through the regular inspection in the growing facilities or manufacturing facilities or of course in distribution facilities. Finally, the import or export of the samples are only performed by entities authorized by the National Health Authority in format in Portugal, that provides a declaration to promote the pre authorization of these types of activities.

Sara Figueiredo  11:55  

Now we will talk a little bit about the quality control for cannabis flowers and then for cannabis extracts, you know that your products must be analyzed in a European Union GMP laboratory. In order to enter to these markets. It is really important to note that the quality control in pharmaceutical industry as the main propose to test the products during the different stages of the manufacturing process in order to verify that they are able to proceed the next stages and release the manufacturing process in accordance with the regulations and also specifications. When we talk about the quality control in herbal medicinal products like cannabis based product is really important for two primary reasons. The first one is to validate the safety of these products for human consumption. In fact, human human safety is of paramount importance is high as far as the production of these cannabis based products his concern since cannabis gets exposure with toxins, heavy metals, fertilizers that can have a severe negative impact on human health in another way, the second reason is to verify to confirm that they retained the right constancy needed to have the desired medical outcome. In fact, the cannabis flowers testing are subdivides into four groups. The first one is the identification tests that includes the macro and microscopic features that are used to characterize the herbal properties the herbal product for herbal for herbal utilisations. And it is really important that this type of a test also includes analytical data such as chromatographic fingerprints for the noun, the constituent with no therapeutic activity, and of course in in their absence with analytical markers or active markers. The second group includes the quantification of the content of the compounds with the known therapeutic activities like THC and CVC cannabinoids, I would like to highlight that if terpenes or other minor cannabinoids in terms of content is stated is labeled. So, they are considered has an active ingredient. So the content of these compounds needs to be no need to rise in the scope of batch release or during the stability studies. The other groups include the purity testing, that includes not only the impurity arising from the starting material life microbial contamination pesticides, heavy metals and so on, but also the impurity arising from the degradation of the herbal proper, the Abra sorry, herbal product like CBN, but also the impurities arising from the manufacturing process like residual solvents. The last group includes the functionality test that needs to be performed in the finished product, herbal medicine our product like tablets, capsules, or our solution that includes the quality attributes uniquely associated with a specific dosage form. For instance, if we consider a solid dosage, solid dosage form, it makes sense, it makes sense to perform some tests like this integration dye solution, Agnus, but when we talk about the liquid dosage form, relative density and refractive density needs to be evaluated. According to do the monography for cannabis flower there are essentially three tests for identification proposals. The first one is microscopic examination in these tests, we pretend to evaluate the microscopic structure from a cannabis plant in order to differentiate it from other species in the femoral inflorescence. As we can see here, can can be available and divided or fragmented into their individual constituents as we can see here. And usually these these, these flowers can be presented in their fragments for practice, but don't close the base deals or the sections of the Pentacles it is really important to know that all of these structures, particularly in the cases of flower organs, are covered by an extracted resin gland large hair, the other tests is to evaluate the microscopic structure has we can see here it may include not only the glandular structure, but also the air gland large and also the EPDM etc. There may be these fragments, these tests is performed under microscope with the use of chloral hydrate solution. And the last test for identification proposes is performed by thin layer chromatography in these tests is really important to assess qualitatively the presence of THC and CBD compounds. In these tests the simple solution is eluted in a cheap TLC plate composed of silica gel associated with the standards for CBD and THC cannabinoids, the overlapping have these spots at risk. This the same retention time and with similar color and size for both standards and sample will predict will confirm the presence of these cannabinoids in our samples. This qualitative data is complemented with the quantification of the cannabinoids contents at the cannabinoids say is performed in the pulverized sample and the extraction of the cannabinoids is carried out with the use of an organic solvents like it's an all and then the injection in HPLC I liquid I performance liquid chromatography system that in fact we can have the data acquisition at two waveforms being the opportunity to have two different chromatography the first one with the non acidic forms at 225 nanometers and the other one we have the acidic forms at 360 nanometers. The quantification of the sample responses is performed against the calibration curves with whose concentration is exactly known. I would like to reinforce that the most commonly obtained degradation products CBN is also evaluated by this chromatographic system. The determination of cannabinoids edgecliff is performed by an internally validated method based on the monography for cannabis flour from German Pharmacopoeia. The quantification of the terpenes evolves the next Retief metadata ology and relatively similar to previously described for cannabinoids, but in fact the detection is done by GC gas chromatography instead of HPLC due to the volatility of these threepenny compounds. Also the determination of the terpenes at left is performed using an a validated methods based on the literature from Canada for cannabis flowers. Now we'll talk about some tests that are used to monetize the safety and purity of cannabis based products and to you know, the reasons why these tests are so critical in the scope of quality control of cannabis based products. So, in fact, the answer is related with the fact that cannabis plant accumulates high concentration of substances in its lifecycle particularly during the growing stage being described as Iper accumulator plants. In fact, as some compounds some toxic compounds like heavy metals, fertilizers, pesticides and so on, can be absorbed can be absorbed very easily, very, very fast or if it is really important to note that this is the reason why these compounds can be present on the finished products. So, this type of test is really really critical during the quality control of these substances.

Sara Figueiredo  21:43  

As I mentioned before, the quantification of CBN is included during these purity tests. But in fact, some additional tests can be performed to evaluate these safety of the products. The determination of foreign mirror is, is performed by waiting happily swept under grams of the sample and spreading it it's an a thin layer, examine the presence of foreign mirror by visual inspection. And in fact, herbal drugs should be free from insects, molds or any animal contamination. In the other ends, the quantification of moisture content is of paramount importance important since the presence of water can promote the development of microorganisms and microbial contamination of the cannabis based products. It can be evaluated by two different methodologies. Not only the loss on drying predicted in that monography using a vacuum oven during 24 hours at 14 degrees Celsius, but also in an easier and faster way using Carl Fisher with oven. The purity tests also includes the evaluation of microbes by microbiological contamination of these products, we can subdivide into two groups. The first one is the enumeration tests that include not only think but also temp determination, we use non selective culture median in order to evaluate the total microbial charge of our products. And on the other hand, we have the pathogen screening testing, in which we use specific culture media in order to select the development the growth of a specific microorganism responsible for certain pathology, the microorganisms to be selected to be tested. Depending not only on the dosage form, for instance, Pseudomonas aeruginosa or Staphylococcus aureus can be handed to the standards panel in for respiratory or pulmonary route of administration. But it depends also on the markets in which the product will be commercialized. For instance, if we talk about Israel markets, we need to consider the screening for some additional microorganisms like listeria CJL and it is a requirements the most commonly used microorganisms. pathogens are salmonella, Italy shakily and also gram-negative bacteria resistant to build salts. The safety of these cannabis-based products also depends on the toxicity of byproducts from metabolism. of these microorganisms. Therefore, there are some substances like aflatoxin b one b two G one G two and also okra toxin A, which are mycotoxins, produced by molds like Aspergillus and Penicillium, that they are highly toxic for human consumption, considering the Imanol suppressor, teratogenic, mutagenic and carcinogenic potential. For that reason, these compounds must be below to a specific level that are considered safe for human consumption. The specification for these compounds are described in general chapter of European Pharmacopoeia to wait 18 to 822 for effort oximes and ochratoxin. A lab has developed and validated an internal method for the quantification of both aflatoxin and okra toxins that can be used for cannabis flowers. In this methodology, the sample solution is eluted in immunoaffinity column in order to retain the components of interests that are then quantified by by HPLC coupled to Flora sense detector and it can also involve post column derivatization by photochemical reaction some heavy metals like cadmium lead Mercury must be within a specific limits and the these determination should be performed not only on the finished product but also in the subtract soil irrigation waters based on the cannabis plant has an iPad accumulator has I said before and has a way to monitor wise the safety of the spreadex Laugh has a GMP lamp equipments when ICPMS equipment that allows the screening of several of these metallic components by an eternal methods validated for these proposals. Concerning the cannabis extract, we know that these preparation are obtained after the submission of substances to an extraction method. And its main includes the addition of an inert excipients like middle chain three gli series, when we talk about the quality control of these substances is relatively similar to the previously discussed for cannabis flowers, but I would like to highlight the importance of these two perform the residual solvents testing due to the use of these during the manufacturing process. And of course, if some contaminants contaminants tests like heavy metals or have or pesticides are were not performed in the flowers testing, so it is really important to quantify in these products. Almost at the end of my presentation, I would like to address some analytical references. As we know the quality control of herbal medicinal products should be in accordance with the the updated European guidelines and also Pharmacopeia European Pharmacopoeia, particularly the specification of the medical cannabis-based product must be defined between the producer and GMP manufacturing, taking into consideration the requirements of each country. These criteria must be properly documented and should be includes the acceptance criteria for identification consents and purity testing. herbal medicinal products like cannabis-based products can be analyzed by the use of internal methods. monographs of nation of Formic EPS as I said before, and General Chapter of European Pharmacopoeia for effort oximes, okra dog seems pesticides, Fe metals, residual solvents, microbiological control and so on. The National monographs forum German Netherlands Danish and Swiss for make-up for applicable for cannabis flowers and cannabis extracts. In fact, are there are different monographs but there is no unharmonized The Pharmacopeia rupee and monography, applicable for both cannabis flowers and cannabis extracts. But in fact, the European Pharmacopoeia published in these here a draft for cannabis flowers with the comment periods until the end of this year. So, I think fortunately, good news will will is expected to come soon. At the end of my presentation, I would like to refer about the stability studies if in fact you need to have stability data to support the submission of your products in European Union markets. Stability testing is mandatory obligatory requirements for the results registration and submission process for all medicinal products including herbal medicinal products like cannabis-based products, stability, testing, and according to ich q1 A and I quote, to propose is to provide evidence on how the quality of the drug substances or drug product varies with the time under the influence of a variety of environmental factors such as temperature, humidity, and lights, stability testing are intended to establish not only the retest period for the drug substances or a shelf life or drug product, but also to define the recommended storage conditions and the primary packaging materials. Ultimately, stability testing

Sara Figueiredo  31:39  

Is so critical to ensure the health of the patient and wellbeing of the manufacturer, since it guarantees the product quality and safety. As I said before, you need to consolidate all stability data from formal stability study. So, I need to clarify some concepts like climatic zones in fact, roll are subdivides into four climatic zones one that are moderate zone two that are subtropical zone three, hot and dry and zone four tropical the environmental condition that you need to perform your stability testing should be evaluated in accordance with the climatic zone in which your product will be commercialized. For instance, if we are talking about a country located in Europe zone, we are talking about zone two. So the long term stability testing needs to be performed at 25 degrees Celsius and 60% of relative humidity. But if in other and if we talk about the southern part of America, you need to perform the long-term stability testing at 13 degrees Celsius and 75% of relative humidity CCTS considered has zoned for finished just to refer that the specific requirements for the quality control of cannabis-based products are sometimes challenging. The storage of the samples need to be performed in a space in specifically designed and secured facilities and of course during this processing, all the access should be controlled. In Portugal for instance, it means that represent a level three security measures within 24 hours cameras, security and cameras cover all the areas in which the medical cannabis products are handled and darks. The requisites for the transports and waste management are also so so challenging since it is needed to implement some security measure like data logger with geo tracking, it is really important to perform the reconciliation of all quantity of the samples and of course, all movements needs to be recorded. It is really necessary to have special license for national health authorities in order to perform the import and export of this type of the samples and of course, it is also required a declaration from custom customs entity to perform this process. And of course, I would like to highlight that quality requirements for this type of products are so critical to guarantee the quality and the safety of this product. There are some key points that I would like to I like to share with you, of course in the cannabis industry. These markets have different specificities and requirements with the different revision of regulation. And the company's needs to be adapted to these requirements. The definition of the tests and specification needs to consider all the specificities of the cannabis based products. And it usually use complex methodology to perform all analytical activities in the scope. And of course, stability studies are so critical to consolidate all the certificate data, data about your products. And that brings us to the end, I would like to thank you for your time and attention today. And thank you.

Rob Perry  35:55  

Perfect, thank you. Thank you very much, Sara, that was excellent. I, I saw some questions popping in there in the in the chat, which we'll willing to get through very shortly. Just because no presentation is complete with a little bit of a look at how the GrowerIQ system can help you work through some of these mechanics. Vegar is going to just take a brief run-through through the GrowerIQ system before we get into the Q&A follow-up. 

Vegar Samuelsen  36:29  

Thank you. Excellent. Yeah. Thank you. Thank you, Rob. Thank you, Sarah, for sharing your valuable insights and wealth of knowledge with us, it's really a great presentation. So yeah, as Rob mentioned, we'll take a little detour over to GrowerIQ. As you know, it goes without saying the QA quality assurance personnel definitely have their work cut out for them. Fortunately, with GrowerIQ, and we've made it very easy to perform a lot of the tasks that QA's are responsible for, while maintaining a high degree of flexibility along the way. As you probably guessed, based on Sarah's presentation, we'll quickly take you through the GrowerIQ platform to show you how we can work with and manage the samples throughout the application. So yeah, I'm kind of on our landing page right now. And why don't we head over to our greenhouse because I've got a batch of our faithful golden goats, which is hanging out in our drying stage. So right now we're in rooms view, but I can always switch to my list view here. And here's our golden goats. As you can see that it's 1.25 kilograms, dry material right now in the QA stage, and it's in our drying room. So I'll just hyperlink into that. And we can see our little pictogram on the far right, so we've gone through harvesting, drying, and now we're at QA. And as mentioned, you know, one of the nice things is, you know, we can take a sample at any point in the batch lifecycle, and even in the lot level. So, you know, this create sample button, which is really handy. It's always available, allowing us to take samples at all different stages, whether it's, you know, for just research, analytical testing, retention, or as part of our three-stage QA release process. So, yeah, why don't we go ahead and just take a sample. So just, you know, note our weight, 1.25 kilograms, go ahead and click here, we can choose a quantity and say it's 50 grams for our purposes, or sign a scale. handled, see here, put it in our shipping export room. Let's see here, all the sign off on that as well. Confirm. So fairly simple to create a sample. Now that we've created it, you know, we can see our samples down here in our samples tab. Here's a sample as a unique ID shows the variety golden goat, it's 50 grams, where it's located, the date it was created, and the sample test status. You'll also notice in the activity log, there'll be a record of this, that gets merged into the master batch record, which I'm kind of hovering over right here. Again, it'll include the timestamps who logged the activity, how much was sampled? Yeah, all gets merged. And you can see right there, create the sample. And click on that for more information, kind of gives me a quick overview, which is handy. Yeah, so you now see that we've lost our 50 grams here. We're now at 1.2 kilograms. And, you know, from here, we can do further things with the samples. I mean, we could send it off to the lab, which is maybe what we'll do. So I can hyperlink into the samples from this tab. And this will take me to the sample inside the sample repository within the application. You know, I can edit the sample name, I can move the room print the label and And of course, I can send it to the lab. That's this nice little button here. Anyway, and up until now, I've been navigating using the hyperlinks, but it's important to also take a step back to realize like, where we are in the application. So right now, we have landed, like we're inside the QA module, a lot of good stuff here for the QA personnel. You know, we have an activity log, which shows you like every single activity that's, you know, been done in the system, who it's been done by, you can filter it, you can download report on that, you know, we have our Health Canada reports, activity reports, you know, client and inventory reports here as well, which are nice. You can go back samples where we were destruction managing that history and the destruction reports. Of course, we can manage recalls, Kappas deviation reports here as well, as well as our sanitation activity. So good central place for, you know, a lot of work to be done by the QA personnel. But yeah, we'll keep things on topic here and jump into our samples lab. And we'll find a sample of golden goats, which is right at the top here. And we can hyperlink in and send this off to the lab to get our lab results. So quickly, I'll just select that, I'll select an account that's tied to the lab that we're using. In this case, we'll use great white north. And I'll sign off that I sent this.

Vegar Samuelsen  41:30  

So basically, the way it is no longer in our facility, and it's no longer in any room. Because it's off premise. Now it's been sent. So if I was to look at the samples Overview tab, you'll see our golden goat here is no units. And it's no room because it's sent to the lab. So some time goes by, we can, you know, our results come back in, we can definitely record our lab results here. So quickly, this record our lab results, I can upload our our lab report here, I can render a pass, and I can sign off on that as well.

Vegar Samuelsen  42:12  

And the nice thing is, when I'm in the sample, I have a nice hyperlink here to go to my source inventory, which just conveniently takes me back to where the sample was sourced from.

Vegar Samuelsen  42:27  

So from here, we can now you know, embark on our batch release, looking can render the visual visual inspection. So click on that we can say hey, this is the pass our product was great. And I'll say I inspected it and approve it as well.

Vegar Samuelsen  42:54  

So once that gets logged, I can go to my QA review. And I can select my COA as well here. This one I'll need a digital signature.

Vegar Samuelsen  43:10  

And our final preview for this batch will say we'll release and submit. Yes, so all of that gets merged into the batch record as well. And again, you know, we have our, our sample down here we have our lab results on a separate tab as well. We can even view that document it gets stored in our document repository, which is nice. And you know, that's really it's, you know, if we wanted to do this on a lot, if we're not saved roofing material, we're bringing it in and repackaging. You know, it's the same process. It's really simple. But yeah, I just wanted to quickly take you guys through that. Thanks for joining, and I'll flip it back to Rob. Thank you so much. 

Rob Perry  43:52  

All right, thank you very much Vegar and, and Sarah as well. So, quick snapshot of of how you might move these samples along through the GrowerIQ system. We have a few minutes left and we wanted to save this time to get into questions because I know there a lot of apologies in advance if we don't get to your question or if you don't feel comfortable posting it or or reaching out during during this webinar. Just reach out afterwards by phone or email and we can we can answer your questions get you connected to the right person at at laugh four or whatever is appropriate. So, so lots of questions, mostly for you. Sarah, are you ready? I can start firing them your way. Yes. Okay. So question number one is stability information needed for flowers is well or just derived product

Sara Figueiredo  44:54  

or both. So it depends what is your finished product, but in fact if you're The flowers are your finished product, you need to have all the evidence that these products in this primary packaging are stable during over the time and the stability condition. So you need it depends on your finished product. But yes, you need to have for both flowers or other type of the products. 

Rob Perry  45:23  

Okay, so if someone were going from flower into, I don't know, some finished derivative, they wouldn't necessarily need to put the flower through the testing, but they'd have to push that finish derivative through. Yep. Okay. Perfect. I think that that probably answers that question again. If not, let us know, types of follow-up or get us by email. Another good question here. I know a few people are curious about this. Here in Canada, where where are IQ? At least our headquarters is based? Can Canadian flour be produced and dried, then exported to Europe? Or does the drying have to be done under GMP? I'm assuming in Europe under GMP?

Sara Figueiredo  46:17  

It depends. Because if you have depends what is your finished product, because if you have the flowers, the dried flowers that are then used to another step, another only an additional process. You can to do this, okay. And you don't need a GMP facility to perform the all of this step. But in fact, if your dried product is your finished product, you need to perform these last step in a GMP facility.

Rob Perry  47:00  

Okay, okay, that's perfect. And, you know, maybe there's another question here as well. I mean, does the GMP facility have to be in Europe or can it be in Canada? You know, if you know, a Canadian producer does have, you know, a GMP facility, can they do the drawing there and then and then export the finished product over to Europe?

Sara Figueiredo  47:29  

Okay, okay. Yeah, exactly. Okay. All right. 

Rob Perry  47:34  

So the key is the GMP piece. Got it? No, that sounds good. Okay, on to the next one. The safety measures are essential for safe consumption. And I believe producers already to follow the GCP guidelines. However, I wonder why there's such a small variety of cameras, cannabis based medicine available in Portuguese pharmacies, patients deserve safe and easily accessible medicine. It's fair, I don't know, if you have any insight on, you know, the end product, maybe it's a question of the rigorous testing and import procedure that groups have to go through, do you think? Yeah,

Sara Figueiredo  48:15  

I think I agree. I agree with this, this opinion from hella but in fact, I think it is a way to have more cannabis-based products for the next year, because I think at this moment, we have all regulatory framework and we have the structure or a GMP lab to perform the quality control of this product. But I, in my opinion, the next stage is to train all the medical men, the medical associations and all of these employees in order to promote the prescription of this type of, of products, but because in fact, until now, these products, these products are the last way to have symptomatic relief or to try to treat chronic disease, chronic pain, for instance, but I think it is really important to have the to have all the information to a medical Corporation in order to have the confidence to prescribe these type of products. So I think it is the on off button to to optimize the consumption and the use of these type of products in Portuguese pharmacies.

Rob Perry  49:53  

No, that makes sense. So yeah, they're, you know, outside of actually just you know, going through the testing Getting it in. There's an educational, you know, component to it. And yeah, it is worth remembering that the supply chains are pretty long. And there are a lot of people involved, which is possibly a good webinar topic for us, you know, add another date, but no, I understand that. This is this is more one step to getting it there. Just moving quickly here. timewise. Question here. If we aim to export products to Spain, and Germany or the UK, we should do the stability test for zone one and zone two.

Sara Figueiredo  50:43  

Exactly. Okay.

Rob Perry  50:47  

All right. And a similar one. Yeah. So in the UK or Germany, or Portugal, zone one and zone one. 

Sara Figueiredo  50:54  

So unfortunately, isn't to okay, you need to perform the long-term stability studies at 25 degrees Celsius and is 16%. of relative humidity. Zona to

Rob Perry  51:06  

Okay. Excellent. Excellent.

Rob Perry  51:09  

Okay. motoring through, there are a couple more that I want to get to that people have asked me before that I want to hit just before we start to run out of time. And one is, how long does it take? So if somebody sends you a message, you know, they call you after this webinar? And they say, you know, hey, I have some product that I'd like to get over to you in Portugal, and I would like to get tested. How long does that does that process take generally?

Rob Perry  51:51  

Sorry, did you get that one?

Sara Figueiredo  51:54  

Sorry, sorry.

Rob Perry  51:55  

That's okay. Oh,

Sara Figueiredo  51:57  

I lost my network. 

Rob Perry  52:01  

No, no, no. problem. No problem. That's, that's the problem of working in a modern digital environment. So there was a question. You know, I was asked before the webinar by someone that I think is very, very relevant. And it's if they do have testing on that they want to get done, they have a sample from whatever country they're in, outside of Europe. How long does it take to you know, get the import documents, get the product to you get it tested and get a result? Get a result back to you?

Sara Figueiredo  52:40  

Okay, so basically, it depends on the process from our help national authority format. But normally, we need about one month to have the import certificate from from informants. After that we need more or less three weeks in order to perform all the analytical activities and to obtain the certificate of analysis is really important to note that, in addition to the authorization from health authorities, we need also a declaration from custom entity, and it can take more or less two weeks to three weeks. So in general, we need one month and half or something like that, in order to have all the declarations from outside authorities from Hannity from custom entity and to perform all the analytical activities. Okay.

Rob Perry  53:47  

Okay. No, that's, that's fair. That's, that's one that we wanted to check off. There are a couple more, I saw a couple of grower IQ questions come through as well. You know, and we would love to get to those. So just reach out to that to us and we can we can take you through the program. I do want to hit some of them that are more specific to Laffan and infosol, just because we're a little short on time here. So there are a couple more really good ones that I know people are dying to ask here. You know, so this one is it. Again, another question that I've heard a lot of times is it possible to export non EU GMP flour to Europe where it can then be extracted or further processed and packaged under an EU GMP facility?

Sara Figueiredo  54:42  

Yes, it is possible and in that case is the product that you will export is flour and of course, until this process, you need to perform all the activities in GCP but in fact When you perform the final stages of the packaging and so on, you need to have a GMP facility in the European European Union. Yeah. 

Rob Perry  55:13  

Okay, perfect. And last question just because we're, we're running up against time here. And I do have some other questions I got from beforehand, which I apologize. We haven't gotten to but this kind of covers some of the questions as well. I'm an LP in Canada that has g ACP, certified hemp biomass distillate isolette. What is the first step in getting this product to the European market? So I think similar to some of the other questions, we've heard about getting things over and then processing them, but you know, is there a question in there, you know, do they need to do some testing before that product arrives at say, a secondary GMP facility or how

Sara Figueiredo  55:59  

to commercialize your product in European Union markets, you need to ensure that you have a GMP lab to perform all quality control testing in your final products. 

Rob Perry  56:14  

Okay, so the pre-product, if someone is has a GACP facility, they send it into Europe, it doesn't need to go through a lab before getting to that GMP facility necessarily, right. I mean, probably well, I suspect just because of the other procedures, but not required by regulation. Yeah. Okay. Okay, excellent. Um, I see the clock is ticking down. And I know we've taken you know, a good good hour out of out of everyone's time here. So I do want to thank everybody for for tuning in. If you again, if we didn't get to your question, please email us. Call us. If you'd like to connect with laughs If you have some samples, either reach out directly or feel free to send us an email where we're happy to connect to you. Great facility, great organization. You know, we've we've worked with them over the past couple of years and, and it's it's been fantastic. So I couldn't say more good things. Sarah, thank you so much for taking the time to jump on Vegar as always, Great work. Great work on GrowerIQ there. And thank you to everyone and if if we don't talk to you have a fantastic holiday season and then we'll see you back in 2023.

Rob Perry  57:44  

Yeah, bye for now.

Vegar Samuelsen  57:46  

Thanks, everyone. Bye