RDC 1000/2025 establishes a unified electronic prescription system (SNCR - National System for Control of Prescriptions) that integrates all prescription types (notifications, special control prescriptions, and retention prescriptions) into a single national database, requiring 14-digit numbering for all prescriptions, mandatory ICP-Brasil qualified digital signatures for controlled substances, and pharmacist access through AF (Authorization for Operation) rather than Kines for private pharmacies, while physical prescriptions remain valid but require proper completion with patient identification, medication details, and dispensing documentation.
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RDC nº 1000/2025 - Receituários físicos e eletrônicos e acesso ao SNCR, o que você precisa saberHinzugefügt:
Hey guys. Goodnight.
Welcome everyone to this very important live stream.
Well, good evening to all the pharmacists who are watching us tonight. They're with us on this very cold Friday here in São Paulo, very freezing.
But we're already here, warmed up, ready to address this very important topic.
And before we start our live stream, I want to invite you all to join our channel, okay? Now the council has a brand new channel, it's the official CRF São Paulo channel on WhatsApp, it's on WhatsApp. So, uh, I'd like you all to be able to be with us there. We've included a lot of important information for you, including information like that from the RDC.
So, it's very important to have them with us.
It's an interactive channel, so it's important that you participate with us, right? It's a pleasure to have this new channel of communication with you. So, today we're going to discuss two topics that, as I said, are quite relevant and current, especially concerning pharmacists who work in dispensing medications. And Anvisa has been publishing these RDCs, right? Today we're going to talk about RDC 1000 and RDC 1015, which have been driving us a little crazy at the counter, right? Well, so, we all still have a lot of questions. So, uh, we hope that today we can clarify things, right? Well, it's important to say that we're going to first address the issue of RDC 1000 of 2025, which brought changes applicable to electronic prescriptions as well as physical prescriptions, both electronic and physical. And we'll also touch a little on RDC 1015, which has also raised many questions, and which deals with procedures related to cannabis products.
And to help with this topic, I have with me today the participation of Dr. Adriano Falvo, who is our director and general secretary here at CRF São Paulo, right? Yes, and he's also an expert in regulatory affairs, he's been answering questions. He 's from São Paulo, but he's been answering questions from pharmacists in São Paulo and all over Brazil, right? He is also invited to give lectures in various Brazilian states. So it's a source of pride, is n't it, to have Dr. Adriano here with us, someone who studies these topics extensively and is always ready to help us all? Okay, so I want to call on Dr. Adriano now, who's already here on the screen, right, Dr. Adriano? So, to begin, we'll start with the changes that have already occurred. With the implementation of RDC 1000 in 2025 and the issues that are still expected to arise, right? We've been receiving a lot of questions here at our pharmaceutical guidance department. So, we initially listed 10 main questions that we have. I'm going to be doing this challenge with Dr. Adriano to answer our questions. So, Adriano, welcome!
Hey, please say goodnight to everyone who's joining us tonight. There are many people from São Paulo, but also many people from elsewhere.
Goodnight. Good evening, everyone. It's a great pleasure to be here to discuss this issue of RDC 1000 of 2025, and now it's also starting to catch on a little with RDC 1015 of 2026 regarding cannabis-based products. So we're going to address these two issues regarding this new RDC (Regulatory Resolution) that's having an impact, specifically the notification process. Some people say things like, "Oh, old notifications aren't valid anymore, they're not valid." So, I think this debate, this live stream, will be very enjoyable for clarifying many things. So, I want to thank all the pharmacists in the state of São Paulo, and throughout Brazil. I see here, there are even people from Juazeiro do Norte, right? Hey, São João, São José da Bela Vista, right? Also, Alisson, and quite a few other people who may have already attended some courses and are here today to update their knowledge, because it 's a major concern of this organization to disseminate knowledge. Well, Anvisa has been publishing RDCs (Regulatory Resolutions), normative instructions, and it's important that the agency, in a way, can contribute this knowledge to the professional who is there at the front line, okay? So it's a great pleasure to be here, Luciana, and let's have this lovely live stream together, God willing. Let's go. Let's go. Look, Adriana, you mentioned Juazeiro do Norte, but there are people from Pernambuco, from the interior of São Paulo, Pim da Manhangaba, Atibaia, Rondônia. Hey everyone, welcome! It's a pleasure, CRF São Paulo. We always care about our pharmacists in São Paulo, but we're also always at the forefront in serving all pharmacists throughout Brazil. So we are here to help. Oh, there, Assis, Caraguatatuba. Welcome, everyone. It's great to be here with you guys on a Friday night, isn't it?
Pharmacists love to talk about legislation.
Let's go, shall we? Either you love talking about legislation, or it's just the daily grind that keeps us here on Friday night, right, folks?
Oh, land of Vupor, there's Votuporanga, land of our friend Malta, there are also quite a few people. Piracicaba in your land, land, in my land. So, let's go, everyone. Okay Adriano, so to start, because this live stream is quite long and we have a lot of questions, let's begin with these 10, shall we? So, Adriano, I'd like you to tell us how RDC 1000 of 2025 also impacts other sanitary regulations. I think that's a question many people have.
Okay, okay, so I'll start designing it there because it'll be easier for you to visualize, alright? So, when we talk about RDC 1000 of 2025, it may not seem like it, but it's an RDC that, at first, when everyone read it, they imagined was simply a basic RDC, with a simple text, but it's not. This RDC (Regulatory Resolution), it directly impacts our Ordinance 344 and Ordinance 6 of 1999. For those who don't know, Ordinance 6,999 encompasses and consolidates all the normative instructions of Ordinance 344. So, even if we address all the questions you have about Ordinance 344, the answer is in Ordinance 6,999. This alters our issue with RDC58, regarding the B2 prescription notification, and directly impacted RDC1/2011, telidomide. In RDC 471 of 2021, which is now called the class of medicines under prescription and retention, in RDC 873 of 2024 regarding the issue of territorial validity and where the national prescription control system is implemented, and mainly meets the requirements of Law 599173, Law 13.732/2020, and Law 14063 of 2020. So, it is an RDC that really changed, that impacted in a very significant way, Luciana.
That's right, isn't it? It really interferes, doesn't it? And the crazy pharmacist. And we, who didn't even like attending Deon's classes, huh, Dr. Adriano, now we're here, having to relate the RDC (Regulatory Technical Standard) to various regulations. Perfect. Look, there are people from your hometown here too, you know, Adriano?
Presidente Prudente, Eneida. Okay, cool. Yes, Alexandre, we'll address RDC 1015 a little bit, after RDC 1000. Adriano, so let's move on to a second question, which is also a very common one: will there be changes to physical prescriptions?
Well, will physical prescriptions continue to exist or not? I think that's a question that everyone's asking.
Well, when we talk about notifications, I think it's important that we understand this live stream well. First, we're going to talk about physical notifications, right? Those that already exist, those that are issued directly by health authorities, which are permitted for their production. So, physical notifications will continue to exist. OK?
Therefore, all prescribers, and when we say prescribers of medications under Ordinance 344, we mean dentists, veterinarians, and others, will continue to request their prescription pads from the health authority. It's also important to remember that notification forms are not specifically provided to individuals such as doctors and veterinarians, but also to legal entities like clinics, hospitals, and charitable institutions. Therefore, all these individuals and legal entities must contact the health authority to fill out their forms, which will be entered into the National Revenue Control System, and through which the health surveillance authority will then provide authorization for production. One change we already have here in the case of RDC 1000 is that the yellow prescription notification, which was provided by the municipal health authority, was produced in the state, sent to the municipality, and then provided to individuals and legal entities. So, what happens next? Surveillance agencies are no longer required to provide the checkbook free of charge.
However, in the questions and answers section of Anvisa (Brazilian Health Regulatory Agency), it is made clear that it remains optional for the municipality to continue providing this prescription pad free of charge to the prescriber, whether an individual or an institution, correct? as needed. Ah, of course, the vast majority will end up choosing to provide the numbering so that these institutions can print their checkbooks, right? Never forget, folks, that every time the prescriber picks up this prescription pad, it is their great responsibility to fill in all the fields correctly. We practically don't have rules or laws in Brazil, right? Whether they are federal or state regulations, except for Acre, where it seems there is a specific rule regarding data not filled in by the prescriber, what can the pharmacist do? To prescribe. prescribe, not fill in that empty field. So, it's also important here, and I know for sure that we must also have many health surveillance agencies that, when issuing the prescription pads, informed the prescriber of the need to correctly fill in the name, address, and CPF (Brazilian tax identification number), right? Filling in the full name of the medication, or prescribing the generic name, its concentration, its pharmaceutical form, and the quantity is very important. It's not simply about including the box; you can include the box, but it's important to highlight this in the dosage instructions. It's one tablet every 8 hours, one tablet every 12 hours, or one tablet a day. But why a long treatment period? Because the pharmacist is very important to him. If I can understand the post-operative period properly, I can provide a basic and ideal solution to the patient's needs. Why?
Simply administering a certain medication every 8 hours is one way to manage the situation, but for how long will the patient need to use it?
Could he have a chronic condition?
That's why we strongly request support from health authorities.
We are also starting a new project, through which we can discuss with the health authorities their responsibility to inform the president about the correct completion of the form. And of course, this notification will always be retained at the pharmacy, never forgetting, the notification, the physical notification, it will continue to exist, right? Whether for individuals or legal entities.
Luciana, okay? OK. Well, Adriano, I think that's perfect. It became very clear, right? That's very well explained, but we'll still go into that, right? Well, having the physical prescriptions, right? Okay, valid. Well, before we move on to our third question, I also wanted to point out that there are people here, look. People arrived from Araçatuba, from Mato Grosso. Welcome, right? Roraima, Rondônia, Piauí. That's really cool, guys. Welcome everyone!
Hey Adriano, thanks for clarifying things for us regarding physical prescriptions. I also think another very common question that comes up and reaches us is regarding the models and notifications, with the changes brought about by the RDC, right? But what about the old models, can they still be used?
So, let's go. Well, from the moment the RDC (Regulatory Resolution) is published, it revokes the models from Ordinance 344.
So, many people imagined that they could no longer accept the old models, correct? On the contrary, folks, it was revoked for its creation.
So, there are many institutions, there are many prescribers who have made their prescription pads, and there is a set time frame. Look, and those older models that you're seeing here in the first notification, B, in the older model. I used model B as a basis for you. Wow, so he can continue using it as long as it's in stock, yes, no problem at all, folks. Okay? Anvisa never released a statement saying, "Look, the old model will be valid until date X." No, that doesn't exist, right? So, as long as it's still in stock, they can use it. Now, if I ever saw a technical note or instruction released stating: "Look, the old models can no longer be used, this will be widely publicized, whether by municipal, state health surveillance agencies or by Anvisa itself, and also replicated by entities and professional councils." Perfect. Yes, it can accept the old notification templates. However, Anvisa then released the first notification form, okay? I'm using base B. The first notification model you see here, I'm circling it, which is the one in the middle, is the first model for initiating garment production, so that health surveillance agencies could authorize garment production for individuals and legal entities. But notice one detail: the first model only included the patient's name, their CPF (Brazilian tax identification number), or, if the patient was a foreigner, their passport number, correct? And then we had a second version which expanded it to include the patient's name, CPF (Brazilian tax identification number), passport number (if the patient is a foreigner), and address. Why this change from the first version to the second version as a result of Law 5991, which mandates the inclusion of the address? So don't be surprised if you see all three models circulating, okay? Both the old, now revoked model and the first version, which only included the patient's name, CPF (Brazilian tax identification number), and the third option, the patient's name, CPF, and address. You might be thinking, "Wow, wo n't this cause confusion when I'm doing my record-keeping in my software for submission to Anvisa?" No, the data sent to Anvisa is the buyer's data, not what other data? From the patient. Perfect. But why do these fields have to be filled out correctly and completely? By the prescriber.
Very good. Perfect. Very well explained.
Confusing, right, guys? But thankfully Adriano is here to save us.
But accept them all.
For sure. So, Adriano, what were the main changes in the new models? Well, we already know that we can assist the older clients, so, folks, no need to panic, we can assist them. So, explain to us now this issue of changes in the new models.
Okay, so let's talk a little bit about these changes.
First, if you look at the old model, I'll even go back to the projection here, take a look at my old model. It featured the letter F, which stands for federal unit, and a number consisting of seven digits, correct? And this should be based on the state's abbreviation, like São Paulo, or the number 35, correct? And the numerical sequence with the new model, note, the number is now a composition of 14 digits. What are these 14 digits? So, let's go. Law 13.732 of 2018 amended article 35 of law 5991.
This amendment not only allowed for the validation of all prescriptions throughout the national territory—and when I say prescription, I also include notification—but also implemented the national prescription control system.
So she takes the lead, she assumes the responsibility of releasing the numbering to the health authorities to allow the production of what? In this case, we are now in the notification phase, correct? And in this way, Anvis ends up having a single database for the entire country. Previously, these numbers were provided to the municipal health surveillance agency by the state, but not anymore. It is Anvisa that provides this information. This allows us to even check that notification to verify its authenticity. So let's try to understand a little bit about how these 14 digits came about. The first four digits correspond to the year and month by which the health authority, then 25/07 on the day in the 7th month of the year 2025, was the year and month by which the health authority granted authorization for the production of this prescription pad. Then the notification type matches. Look here, number two. Number two corresponds to notification B. If it were a notification colored yellow, it would be number one. Next comes the numerical sequence in relation to what?
To the state. In the case of São Paulo, it would be number 35. In the case of Rio de Janeiro, 33. In the case of Espírito Santo, 32.
Correct? So, each state has its own sequence. And then a sequence of seven numbers. Look here. So, this is the 14-digit numerical sequence from now on. What errors did we start to notice? This is very important. So, let's go.
First, look what we noticed. That initial sequence 2572 should n't be in the number section, it should be in the footer; that's an error. Therefore, health surveillance agencies need to be very vigilant and well-informed.
This sequence of 14 discs should be in a single field, not part of it here in the footer. Another thing I didn't mention here is that in this numerical sequence, sometimes some printing companies omit the first zero, which is not allowed. That leaves only 13 digits, right? So you have to be very careful that this numerical sequence has 14 digits. And then we were able to see some absurd things, okay?
Some prescribers took this notification template from RDC000, put their name as the prescriber, their CR (registration number), their address, and then they had an old prescription pad of the old model, imagining that that model could no longer be used, what is it? And he took that sequence and put it here. No, guys, you can't do that, okay? No way. That's a mistake. And the worst part was that he went beyond just taking the new form, putting his name, his CR number, his address, getting that numerical sequence, and digitally signing that notification. There is no signature yet. Now, how can I verify the authenticity of this notification? So, if a notification B suddenly arrives in your city, perfect. Wow, but that blue has a different shade. It's very simple. How will we verify if this is an authorized notification? Simply enter the link I'm showing you here, or search for " SNCR Anvisa" on Google, click "access the system," " consult the prescription," enter the 14 digits here, and get the captcha. So in this case, 23 + 6 = the value will be 29. You enter the number 29, consult the prescription, and it determines that this is a prescription for what?
Duly authorized. So, it's possible for us to verify that. Therefore, what also changed in the fields, in the issuer field, which was for individuals, the prescriber's name, their registration number, and their full address remained the same. What has changed is that the company must now have the institution's name, full address, phone number, and the inclusion of its CNPJ or Kines number. So, please note that for these new models, health authorities must inform prescribers, and in the case of legal entities such as Santa Casa clinics, to include their CNPJ or Kness number. On the patient's side, we will have the patient's name, CPF (Brazilian tax identification number), passport number if the patient is a foreigner, and address. Don't forget that we're going to have that notification template that came without an address, which is still valid, okay everyone? So, there are notifications in this new format that will only include the patient's CPF (Brazilian tax identification number) without an address, but from now on, the health surveillance agencies will order the production of this new format with the patient's CPF and address. In the case of the old, now revoked, but still valid, notification, it will only include the patient's name and address.
Perfect. When the patient does not know their CPF (Brazilian tax identification number), the prescriber has the option of writing " does not have" in the CPF field. Perfect, which doesn't prevent him from accessing the medication. And in the case of veterinary prescribers, it is the name of the owner or guardian, the CPF (Brazilian tax identification number) of that owner or guardian, in the case of a foreigner, the passport number, full address, species, breed of the animal and size. In the buyer identification section, what happened was basically a simple change. Where we used to collect ID cards, what will happen now? The CPF [Brazilian Individual Taxpayer Registry] is being adopted as a national general registry, replacing the IRG [Brazilian National Identity Card], right? In this case, the CPF (Brazilian taxpayer ID) should be used in place of the RG (Brazilian national ID) on controlled prescriptions and prescription notifications. So, in the case of those who receive the old version of Ordinance 344, which still had name, ID, address, and CPF written on it, the ID can then be replaced by the CPF. And if you remember that old model, you had a space where you could put your name and the date of dispensation. Folks, this was already foreseen by ordinance 344. It's not just the name of the pharmacist dispensing it, it's not just the date you're dispensing it.
Decree 344 stipulated that we had to record the act of dispensing and identify the dispensing establishment, correct?
Now, this information, this note, won't be written on the front; you'll make a note on the back. So it is necessary, this can be done in handwritten form. If you want to make a stamp, you can make a stamp. If you want to ask your pharmacy's software developer to create a label that you can attach to the back of the notification, you can, but it's important to include the establishment's name, CNPJ (Brazilian tax ID), Kines (Brazilian business ID), full address, pharmacist's name, and the date they are dispensing the medication, as stipulated by Ordinance 344. And in the case of Ordinance 699, what? The act of dispensation. So here I am giving a suggestion for note-taking, correct? As should be noted on the back of this notification, the establishment's details, as we've already mentioned, the name of the medication or substance if it's a generic, or even the name of the compounded medication. The batch number, the quantity of boxes, or it can be by dosage units. So there's no need to say, "Wow, it's not a box, uh, it 's compounded, it was 60 capsules."
Then, put in 60 capsules. No, I want to put the number of boxes. There were two boxes, but how many pills were in each of those two boxes? So, put in two boxes with 30 tablets each. Regarding compounded medications, every notification or prescription submitted for compounding is recorded in the general prescription book. So, you just need to take that number and write it down here, right? The prescription's registration number in the prescription book. This only applies to compounding pharmacies, correct? In the footer, if you look now, it shows the name of the printing company, its CNPJ (Brazilian tax ID), and address, but the print run from issue number such-and-such to issue such-and-such has disappeared, right? But Anvisa [Brazilian Health Regulatory Agency] states : "It's legal to include the date this prescription, this notification, was printed. Recommended. Recommended, not mandatory. Perfect. And in the signature section, the prescriber can sign this prescription. So, let's imagine if the prescription belongs to an individual, a private doctor, they sign, but don't need to stamp it. If it belongs to an institution like Santa Casa Clínica, they sign. Then, a stamp is used to identify them as a prescriber from that institution, because we don't know which prescribers are part of that institution. And if they still don't want to stamp it, they can identify their signature with their name legibly and their... what? Their CR [Regional Health Council registration number]. This is stipulated in Ordinance 699, item 4.1, prescription notification, and also in item 4.1.3 of the prescription notification completion, article 81, item B. So, I'll read it here for you.
When the professional's data is properly printed in the issuer field, it's Dr. Antônio." Da Silva, he can simply sign the notification. He does n't need to stamp it. If the professional belongs to an institution, a hospital establishment, then yes, it's the Santa Casa de Misericórdia of municipality X, he must identify the signature with what? A stamp, containing the registration of the Regional Council to which he belongs, whether he is a doctor, dentist, veterinarian, or handwritten in a legible manner. This information is so important that it is included not only in Ordinance 344, but also in Ordinance 6, 99, and also in Ordinance 344, in Chapter 5, item H, correct? And here are the new models that were directly inserted by RDC1000. The notification model for humans. And something we have evolved, Anvisa, also publishes the veterinary model in notification A, and the human and veterinary notification model in notification B.
Note that the veterinary model changes here on the left corner to the B2 prescription notification; the new model must be accompanied by the terms, but in this case, the terms have not changed.
The notification for the special prescription of systemic retinoid, which has the symbol here of a woman prohibited for pregnant women, right? But look how cool this is here in the corner, besides the patient's name, CPF (Brazilian tax ID), and address, it also includes the date of birth and sex, the wording, right, which hasn't changed. And in the case of thalidomide, the new thalidomide model, the wording also hasn't changed, the terms remain identical. OK, Luciana.
Luciana, sorry, I was muted here.
Uh, folks, for a Friday night we're doing well, you know, Dr. Adriano? We have over 400 pharmacists here with us tonight. Uh, I told Adriano, wow, Friday was the only day on the schedule. I said: "Oh my goodness, what a rip-off, Friday night, what are we going to do with the pharmacists?" No one will show up.
Look at that! See? 400. So, congratulations to us warriors, who are here on a Friday night, right? After a really busy week at work. That's really cool. Thank you for being here with us. Hey Adriano, there are so many questions in the chat, you wouldn't believe it, my friend, you wouldn't believe it. But guys, don't worry, anything we ca n't answer today, okay? We will then guide you on how you can gain access. A large number of questions. Dr. Adriano already clarified that during his speech, right? But if you still have any doubts, we will answer them for you later through our guidance channel, our guidance department. Rudri, tell us a little bit about the special control prescription. I think she's undergone some kind of change too, right? The fields follow the same applicable rules as the notifications.
Okay, let's go. So, the first thing we learned today was about prescription notifications. It's important to remember that physical notifications can be provided to both individuals and legal entities and have a unique numbering system. When I enter a prescription for a controlled substance, the prescriber does not need to request authorization from the municipal health surveillance agency to prepare it, correct?
And she doesn't have a number. So here we have the old model for controlled substance prescriptions and the new model proposed by RDC 1000. The question then becomes : can the old model continue to be used? Yes, that's correct.
But it's also important that municipal health authorities send an official letter to prescribers, right?
Making it clear that there is a new model for manufacturing. And sometimes it becomes even easier, because sometimes they create that model on the computer, and then it's just a matter of changing the structure of that old model to the new model.
Now, those who have already prepared the paper forms, without any problem, can continue using them for an indefinite period until Anvis makes a statement. Look, older models can no longer be used. Perfect. And one really cool thing, guys, is this right here. The prescription for special control. Anvisa publishes its front page with its fields. It needs to be clearly marked as a controlled substance prescription, along with the issuer's identification, the patient's identification, and the prescription itself, right? Look there, the date, the prescriber's identification, and the identification of what?
From the buyer. Similarly, if possible, they should include the date this special control prescription form was printed. It is recommended. And one really cool thing is that they create an optional printable back. So there will be prescribers who will write the prescription on the front and send you the printed back, which contains the same information I suggested for the notification: the identification of the establishment and the identification of the dispensed product. Unlike a notification, a prescription can list up to three medications, how cool is that? or three substances. All good?
So this verse is optional for the prescriber to print. If you don't print it, as I told you, you can do it by hand, or you can make a stamp that you can put on the back of this special control prescription, or even adjust this detail with your software so that when you are dispensing, it releases a label and you attach it to the back. One question that came up in the Anvisa Q& A was: Can I change the layout of the special control prescription? Yes, folks, you can. The prescriber has the autonomy to change the layout, perhaps adding their clinic's logo, placing a logo there, or creating a design within the prescription. The important thing is that the special control prescription item and all fields are properly filled in.
Yeah, they're maintained. Now, on the issuer's side, the notifications were processed in the same way. If it's from the prescriber, name, CRE, CR and address. If it's a legal entity, in addition to the institution's name, the complete address is also needed, right?
City, state, and phone number, including the CNPJ or kines. So, the impact here is that legal entities must have a CNPJ or Kines. In the patient identification section, include full name, address, and CPF (Brazilian tax identification number).
However, there is no model that is exclusive to veterinarians. Therefore, in this case, for veterinarians who are printing your special control prescription, it is important that they put the name of what?
The owner's name, address, and CPF (Brazilian tax identification number) are required, including the animal's species, breed, and size. Why hasn't Anvisa (Brazilian Health Regulatory Agency) published a specific form for veterinarians? Perfect. So, he only includes that in his special control prescription. And then on the back we'll make a note of the dispensation. Never forgetting that you also need to have the establishment's identification and the details of the medications that were dispensed.
Dismissed. Guys, it's a box, two boxes with 10, two boxes with 20, two boxes with 30 or 90 tablets. What is it important to be what?
Regarding the buyer's data, the LRG (Brazilian Identity Card) has basically changed to the CPF (Brazilian Individual Taxpayer Registry). The special control prescription, to be clear, also applies to both individuals and legal entities. It's a two-part form, and we'll need to have it properly filled out, and we'll retain the first copy, the original copy. And just a reminder, the special control prescription doesn't have a number.
The only physical document that currently has a number, speaking of physical documents, is the notification.
Perfect. And what had the most direct impact on retail? It was common for the prescriber to obtain a private prescription.
When I use the term " private prescription," I mean a standard prescription, which can be from the prescriber themselves or from the institution. This is private prescription, right? So it was common to take the private prescription and prescribe the medication from Ordinance 344, which should be prescribed on a special control prescription. And would the pharmacy accept that, guys?
It could, therefore, be contemplated in decree 6 of 99, in article 84, in chapter 4.2, revenue.
Look what the text said.
Medical professionals, veterinarians, and dentists will prescribe using a special controlled prescription form in duplicate or a regular prescription form. However, article 84 was amended by RDC000.
And from now on, the new text is right here. See? The old recipe is over. It then becomes mandatory.
All medications listed in Ordinance 344 that are prescribed using a special control prescription can no longer use the private prescription form. All medications listed in Ordinance 344 that require a special control prescription must also be prescribed on a special control prescription. You can no longer use the private prescription. But this is becoming a major concern for pharmacists. Why? Because not all health surveillance agencies were aware of this yet, nor were all prescribers. So, it's clear, folks, that this is a time of adaptation, a time of transition, and that these prescribers will gradually receive this information. So, we strongly urge the health authorities to send this information to prescribers, stating that when dealing with medications listed in Ordinance 344, they should no longer use the private prescription but rather the special control prescription, and preferably the new model, correct? And just as it is a notification, when the prescription for controlled substances belongs to the prescriber himself, he can simply sign it. Since it's a Santa Casa Clínica institution, right? He must sign and stamp it, and if he doesn't want to stamp it, he identifies his signature with his legible handwritten name and his CR number (medical registration number), whether he is a doctor or dentist.
The veterinarian.
OK.
Thank you, Adriano. Look, Marl is saying here that you explain things very well, precisely and objectively. I agree as well. I also wanted to highlight the presence here on our live stream of two advisors from CRF São Paulo, Dr. Rosilene Martins and Dr. André Santos, who is in São José dos Campos, accompanied by several pharmacists watching the live stream. Thank you for the recognition given to these two friends and advisors here at CRF São Paulo.
I also want to highlight the presence of our volunteer, Dr. Damares, who is always collaborating in our technical groups. And once again, thank you to everyone from all over Brazil who is here with us. Adriano, so far we've discussed prescriptions involving medications listed in Ordinance 344.
And I'd like to ask you to also touch on other medications subject to prescription and prescription retention, such as antimicrobials and GLP-1 analogs. What are the changes for these classes of medications?
Pharmacists have many questions about this as well. And folks, don't worry, the questions you're asking, I'll give you a really good follow-up later, they 'll all be clarified.
Okay, let's go then. First, we talked about prescription notifications. Just to recap, the prescription notification has a number that is provided by the municipal health authority, right? or in some state. Perfect. There are particularities. Special control prescriptions do not have a number and are also valid for individuals and legal entities. And now I enter a class called prescription and retention medication class.
But what exactly is this class of prescription-only medication?
You knew her as a class of antimicrobial drugs. Wow, so it's no longer called a class of antimicrobial drugs. Now she calls it a class of prescription and retention medications. Yes. Why did this happen? From the moment Anvisa [Brazilian Health Regulatory Agency] was established, it had already been monitoring the irregular use of analogues, the pens in growth-prone drugs, and there was a significant increase in the use of those medications.
Anvisa is creating a very positive strategy. What does she do? It creates RDC 973 of 2025. This RDC 973 of 2025 aims to amend RDC 471 of 2021. And what was RDC 471 of 2021?
The class of drugs that used to be called the antimicrobial drug class. So, right off the bat, RDC973 changes the summary of the resolution. What we used to call the class of antimicrobial drugs, see RDC471, is now called the class of prescription and retention drugs.
So, this RDC973, it keeps changing the text in a way that it always refers to these things, and this resolution refers to the medicines or the class of medicines in the current normative instruction. So what is this current normative instruction? Today we have 132 antimicrobial molecules and five analogues. So, if Anvisa suddenly decides to release two more new analogues onto the market, I'm just making a supposition, okay everyone? I 'm not saying that Anvisa (Brazilian Health Regulatory Agency) has approved it, okay?
But if Anvisa suddenly approves two more analogues on the market, what does Anvisa do? She doesn't need to amend RDC 471 of 2021, right? Regarding the class of medication subject to retention, it simply revokes, it cancels Normative Instruction 360 and includes more medications here.
Perfect. And it creates a new normative instruction. So, it's a very positive strategy. Currently, the normative instruction in force includes 132 antimicrobial molecules and five analogues. So, everything we say about antimicrobials, we're also saying about analogues.
So, let's start to understand a big difference.
Analogues and antimicrobials are not included in Ordinance 344. Ordinance 344 requires a prescription notification or a special control prescription.
Antimicrobials and similar drugs require a prescription from a specialized doctor.
So, look at this detail. If you were receiving an antimicrobial or analogue prescribed on a special controlled prescription at your pharmacy, you were dispensing it irregularly. The doctor was prescribing irregularly because analogues and antimicrobials are not included in the regulations; they must be prescribed on a private prescription form, which can be from an individual, the doctor themselves, or a legal entity such as an institution. And who has the authority to prescribe?
Doctors, dentists, and veterinarians. In this case, nurses have the autonomy to prescribe antimicrobials, provided they are linked to or included within federal, state, or municipal programs or health institutions. Okay, so in addition to the patient's name, it also needs to include their age and gender. Wow, the resolution is the same for the analog model as well. The patient's age and sex are required. If you don't have one, you have the freedom to add it yourself.
Here we have guidelines that allow the pharmacist to include age and gender. He's in two ways. Unlike Ordinance 344, where you retained the original prescription, here you retain a copy, correct? The copy, the original copy, is for the patient. Regarding antimicrobials, they are valid from the moment the doctor, dentist, or veterinarian prescribes them, and are valid for 10 days, correct?
As for agon and analogues, it has a validity of 90 days, correct?
Whenever dispensing occurs, you will record the dispensing date, the quantity dispensed, the batch number, and the pharmacist's initials. In situations requiring prolonged treatment, the prescriber will specify prolonged use. Then comes a detail. If you included the phrase " prolonged use," it will function as follows. If it's an antimicrobial, that prescription that would be valid for 10 days from the start of the mission can now be valid for up to 90 days. This doesn't mean the patient has to take everything all at once. You can dispense doses in installments. It takes him a month, then he returns with the original copy that you've already noted the dispensing on. You write down the second dispensation, correct? For another month.
And when he returns, you take that first copy and make the third note. One detail: the first dispensing of antimicrobials must occur within 10 days, correct? The first dispensing occurs within 10 days. For analogous products, it is valid for 90 days straight. So, in this case, the longer the patient takes to buy, the more difficult it is to offer payment plans of 30 days, 30 days, and 30 days, correct? So now you realize that we have numbered notifications, special control prescriptions without numbers, and private prescriptions without numbers, which serve both individuals and legal entities. These are the official documents that the prescriber can create when issuing a prescription.
Very well, thank you very much for answering that question so clearly.
Hey Adriano, now let's talk a little bit about electronic prescriptions.
Explain to us the context of the changes that led to the publication of RDC 1000 to ensure greater traceability and security in the dispensing of electronic prescriptions.
Okay, let's go then, Luciana. Well, when we talk about electronic prescriptions, I'm going to use two terms here: digital prescription and electronic prescription. A digital prescription is what you are receiving today at your pharmacy, correct? And what Anvisa will be developing is electronic prescriptions. So, let's start by talking about the principle of digital revenue. In fact, digital revenue has a history both before and after the pandemic. What was a digital prescription before? Actually, it was companies that sold software to prescribers, usually doctors, that sold an electronic medical record system, right? Finally, he had the option to print the recipe, which was a printed recipe, allowing him to read it. The F was illegible; he would stamp it, sign it, and send it to the pharmacy. Well, due to the advent of the pandemic, these companies that had these electronic medical records realized that, due to social distancing, it was possible for the prescriber to issue a digital prescription. The digital prescription has a specific format, a specific pattern, as we call it; it's born digital, it has a digital characteristic. So, he created the digital prescription and signed it digitally, correct? When it started to emerge, during the pandemic, which was the moment that really boosted digital revenue, it began to appear within our establishments, and we had a great deal of doubt. My God, where in our commercial law, our law 5991, does it mention digital revenue? Where does it say anything about digital signatures? And when we look for legal support, lawyers have been using digitally signed processes, which have been proceeding through the courts for a very, very long time. And then we discovered that there was Provisional Measure 2200 of 2001, which established the ICP-Brasil public key infrastructure, considered the most secure ICP-Brasil signature in existence. So, what was our attitude? Electronic prescriptions, or digital prescriptions, are starting to appear in our pharmacies. We then asked Anvisa, "Anvisa, can we accept digitally signed prescriptions?" And Anvisa responds to us very well and very quickly. You may accept digitally signed private prescriptions and digitally signed special control prescriptions, but you must not accept digitally signed prescription notifications. So I could accept prescriptions for controlled substances, private prescriptions signed digitally, and less notification. And she made it clear that I had to have a resource, based on what's in the Anvisa (Brazilian Health Regulatory Agency) note, a resource to evaluate, to validate this special control prescription or this private prescription that came digitally signed. Hey everyone, it might not seem like it, but initially there was some resistance to providing services online, remotely. So much so that Ordinance 467 then creates telemedicine, or teleconsultation. Perfect. Later, the ordinance was revoked due to the creation of Law 13989 of 2020, which made it clear that telemedicine and teleconsultation would continue as long as the state of emergency due to the pandemic persisted. But of course, the issue of technological evolution has grown too much, to the point that when this pandemic issue ends, we have the publication of law 14.510/1510 which allows telehealth. So, the Medical Council regulates its telemedicine, the Veterinary Medicine Council regulates its veterinary telemedicine, there's telenutrition, telenursing, telepharmacy, each council regulates its own. But now look at the detail. So we could accept special control prescriptions, private prescriptions, whether physical, online, physical, from a natural person or legal entity, digitally signed, except for the notification. And we needed to have a validator feature. But then what ended up happening? Where did we validate this information? Inside the generating platform.
So, all of us pharmacists would log into the platform where the digital prescription had to be generated, we would register to verify if the prescription was a digitally signed prescription. And on that platform, we even noted things like, " Oh, he's already been dismissed." Wow, that's so cool, isn't it? Where was the regulation coming from?
Where was this regulated? It stated that my obligation was to access the generating platform to perform the validation, correct? And then people started to think that maybe this validation could be charged, but that was just a rumor, okay?
That never happened. Even so, we approached ITI to create a public validator website, which was initially called assinaturadigital.it.g.
golv.br. So what was the difference between validating on the generation platform and in IT? The IT guy would just say things like: it's a digitally signed prescription, and he'd show the type of signature that was used, what? The type of signature used in this digital prescription. And then we had Law 14,063 of 2020, which also amends our Law 5991, introducing digital signatures.
So, look at this cool thing. Now I had a law that recognized digital signatures, but I still didn't have a regulation (RDC) that would guide me on how to validate a digital prescription. This law 14.063, 063, which amends article 35 of law 5991, creates three types of signatures. Simple signature, widely used in hospital settings.
So the hospital buys the software, the doctor goes there, prescribes, right? And enter a password. Who created that password for him? The software developer, simple, fragile. Then we have advanced subscriptions. It's a secure signature; in fact, we use many advanced signatures today.
As private individuals, if I'm going to sell my car, I sign up for GolfBR, correct? It is a secure signature, and there is a qualified signature based on the ICP-Brasil standard. Guys, this is the safest one. Therefore, in the case of this law that amended Law 5991, it makes it very clear for medications listed in Ordinance 344.
I didn't mention analogues, I didn't mention antimicrobials that are part of the class of medications under prescription and intent, but for medications listed in Ordinance 344, the prescription must be signed by the prescriber through ICP Brasil, correct? Ah, but the prescriber can sign with ICP Brasil, right? qualified, all types of prescriptions, whether special control prescriptions or private prescriptions, can be the safest, it is the element that allows for full signature. Perfect. But since it's Ordinance 344, this mandatory requirement from CP Brasil already exists. The others, excluding Ordinance 344 or if the prescriber wanted an antimicrobial from GOV, right? Because it is a prescription and retention medication, it has autonomy. Ah, I want to prescribe a controlled substance medication, but I need a digital prescription and to sign it digitally with GOV. Yes, it's possible, as long as it has a natively digital structure and he signs with GOV. But when it comes to Ordinance 344, I always like to reinforce it three, four, five times. It has to be with ICP Brasil. The qualified one, the qualified one, she signs everything, right? GOVBR signs all decrees except for Ordinance 344.
And then we received news that the notification could be signed electronically. When we saw this announcement from Anvisa, we tried to dig a little deeper into it.
So, what exactly is this digitally signed notification? In fact, it was much more than a notification; it was the creation of the electronic prescription system.
Guys, look at my change now. I 'm switching from using the term "digital prescription" to "electronic prescription pads." So, Anvisa (Brazilian Health Regulatory Agency) selected some platforms as pilot programs, some prescribers as pilot programs, and these prescribers are now integrated into the National Prescription Control System. Who is this INCR? The National Prescription Control System is the one used by health surveillance agencies to issue serial numbers for physical prescription forms. Remember when I told you that a physical document is a notification, a special control prescription, and a private prescription? Correct? Currently, the surveillance agency only provides numbering that comes from the National Revenue Collection System for physical notifications. Therefore, these prescribers are properly registered with the SNCR.
Look at this fantastic thing. So, Anvis is now using this platform. This platform is integrated with SNCR.
Perfect. Therefore, all platforms must be integrated with the SNCR to generate an electronic prescription. Yes.
Oh, but in this case, there's a website from the Federal Council of Medicine, Dentistry, and Veterinary Medicine that does n't offer an electronic medical record, but rather an app that creates a digital prescription. All good? For it to become an electronic prescription system, this application from this particular website also needs to integrate with the National Revenue Accounting System; otherwise, it will not generate electronic prescriptions.
So, here's how it works.
The prescriber accesses this platform, this platform accesses the national prescription control system, and it generates a number. This then generates an electronic document called an electronic prescription, which may be a prescription notification, a special control prescription, or a prescription for retention, which involves antimicrobials and analogues. And the big change is the electronic prescription system; both the notification system, the special control prescription, and the prescription withheld at source, have a number. They have a number, both notification, special control prescription and prescription on retention. So this patient takes this electronic prescription, goes to a pharmacy, and the first step they have to take is for the pharmacy to access the IT website to validate the prescription. Wow, you mentioned going to the IT website, which is now called validar.itit.gov.br.
I'm not telling you to validate it on the generating platform; I'm telling you to validate it in the IT department. So he's going to go to the IT website, validate this electronic prescription, and instead of printing it, he's going to save this validation in a file, correct? So this pharmacy, through its pharmacist, will enter the government system to do what?
In the SNCR. So, look at this cool thing.
I'll show you in a moment how this SNCR (National System for Critical Control) recognizes this pharmacy and this pharmacist. Then he accesses the pharmacist's account on the SNCR and he will do the following: "Lpa, I have an electronic prescription." So I'm going to check if this prescription, this electronic prescription form, was issued to this prescriber in this specific state.
After he did that, what else can he do? Record the use of this electronic prescription number.
This means that if I take this electronic prescription and try to buy it elsewhere, I won't be able to. And what else does he record? the dispensation. The only detail is that all the actions you took—analyzing whether that prescription was issued to that specific prescriber, from that specific state, registering the use of that number, and registering the dispensing—you're doing all of that within the SNCR (National System of Prescription Control).
This SNCR is not linked to your software. It has no connection to your software. So after you've done that, you're going to go into your software and then what do you do? The commercialization process involves your software generating an XML file and then sending it to Anvisa. So, folks, the SNCR isn't linked to the software; you have to access it, complete all those steps, and then, in your software, you can proceed with the sale.
So, the forecast for Anvisa (Brazilian Health Regulatory Agency) to start this electronic prescription system was June 1st, but we observed that practically yesterday, on the 21st, Anvisa released a statement making it very clear that this functionality will happen in June, according to the schedule.
So does that mean it doesn't start on day one? We're not sure, okay? We have to wait for this schedule and the information from Anvisa, but the system is ready, right? The biggest problem lies in accessing the national revenue culture system, which I'll explain to you later, to understand the reason for that. When we talk about electronic prescriptions, it involves notifications, controlled substance prescriptions, prescriptions for exclusive use that dispense with analogues, and prescriptions for analogues and antimicrobials.
Perfect.
All notifications related to electronic prescriptions, whether notifications, special control prescriptions, or prescriptions requiring retention, will have a number. We wanted to ask Anvisa about this, and we did. And Anvisa releases a technical note stating: "Yes, electronic prescriptions will have a number, whether it's a notification, a special control prescription, or a private prescription." Look how cool, guys! For physical vehicles, those who have a number only need notification. Physics, a prescription requiring special control, doesn't have it. There is no physical private prescription. What will electronic prescriptions be like? numbering. And then we start to analyze this legislation.
Note then that ISISA states that every generating platform must be delivered to the SNCR. So we ask: will electronic prescriptions then be provided for both individuals and legal entities? And then comes the response from Anvisa. Initially only for individuals. So, no clinic, no hospital, no basic health unit, initially, although it may evolve later, will have electronic prescriptions. Only the prescriber— physician, dentist, or veterinarian—who is a natural person, will have this functionality, correct, of generating electronic prescriptions; it will not be applied to legal entities.
And then we start reading. So, let's go. Prescription notification. Excellent. The prescriber prescribes Ordinance 344.
Wonderful. And he signs with a qualified signature. It doesn't need to come with a prescription.
Perfect. It's an electronic document.
Unlike physics, where you attach a medical prescription. Not here, this is an electronic document. Secondly, the special control prescription prescribed by ordinance, the prescription for retention, which is a private prescription that prescribes analogues and antimicrobials, does not need to be in duplicate; it is a single document, an electronic document. So we took the opportunity to press Anvisa, saying: "Anvisa, so now we can mix them into a single document, not in duplicate.
The analogy with the ordinance." Anvisa responded to us: "Thank you for your contribution, but not initially, right?" Antibiotics cannot be mixed with prescription drugs (such as those listed in Ordinance 344).
Prescriptions requiring special control will be signed with a qualified signature.
Prescriptions for antimicrobials and analogues, including retention prescriptions, may be qualified or advanced. And what is the date I should consider for an electronic signature – the date of issue? Guys, this is the date shown here, the date the electronic prescription was generated. I'll go back a little and talk to you about it. It's very common to see today that electronic prescriptions haven't yet been implemented; instead, we're using digital prescriptions. Sometimes the prescriber takes a digital prescription that he issued a while ago, and you see a date here where it was issued, he takes that PDF, stamps it, and puts a new date on it. This date will be disregarded from now on, folks; the date for issuing an electronic prescription is this one here. Once a pregnancy has been generated, the time limit has passed, according to the prescription, what should it be anymore? Accepted.
So, does that mean I can continue validating the electronic prescription on the platform where it was generated? No.
Anvisa makes it clear that the appropriate place for us to validate whether a prescription was created digitally and digitally signed is in the IT department, not on the generating platform, correct? For both prescription notifications and special control prescriptions, including prescriptions requiring retention, we will verify the validity of the numbering in the national prescription control system. Yes, and we will only check this for electronic prescriptions, not physical ones. Then we will register the use of that number, preventing the patient from using that electronic prescription again, and we will fill in all the required fields of the SNCR (National System for the Control of Prescriptions), which involves the act of dispensing, identifying your company, and identifying the dispensing. Of course, when you enter the SNCR using the pharmacist's Golf BR code, it has already identified you as the pharmacist from such-and-such pharmacy. So we're just filling in the fields required by the SNCR, which we haven't yet had access to electronically.
Anvisa has made it very clear that it will provide this model and will create a step-by-step manual for accessing the SNCR. Guys, I want to emphasize this again. I have a physical notification. Can I register the use of that number in the SNCR so that this physical notification cannot be used elsewhere? No.
Registration is only done for electronic prescriptions. Perfect, Luciana.
Very good. That's really good, Tria. We already have over 500 people here with us.
My God, that's wonderful. There are so many questions. There are so many questions.
This is great.
Guys, we'll answer all your questions here in the chat, okay? Today it will be practically impossible, but our pharmaceutical guidance department, under the coordination of our dear Daniela Veríssimo, will be answering your questions via chat, okay? It's all these doubts. So, since this live stream will be recorded for you on our CRF YouTube channel, you'll be able to watch it as many times as you want, and these slides will be available, right?
So, uh, don't worry, just log in again and by Monday, or at the latest Tuesday, our DOF will have answered all your questions, okay?
I thought we were going to spend the whole night answering questions. I bought four bu here.
So it is. That's right, Adriano. That's messed up, isn't it?
Friday night, I too am a child of God. I spent the whole afternoon at a conference, the whole day at the cannabis conference, which was wonderful, wasn't it? Uh, here at Transamérica, right? It was a congress that was organized by our dear Dr. Margarete Aquim, who is one of ours, the coordinator of our cannabis group. It was a pleasure, but I also need to have dinner, right? So, otherwise we'll be here until about 4 in the morning, okay? Okay, then, that's good, right? I'm going to have to put away my four tubes of red. Just in case, save them because you'll need them later to answer everything. Guys, uh, I'm also going to ask you something.
Well, we always conduct a satisfaction survey that helps us to continuously improve our events, allowing us to bring you quality events like the one we're hosting today. If you can, please answer the satisfaction survey that our staff is posting here for you through this channel. It's very important for us to know if we're on the right track or not, right? We hope that together we can correct course and continuously improve this service that we provide to all pharmacists in São Paulo and Brazil, okay? I'm counting on you to answer our survey. It's very important to us.
There are people from Pelotas here. I was looking at it now, I'm starting to look at it now.
Rio de Janeiro. There are people here from all corners of Brazil. Very tasty, you know? Very tasty. We even have a board president, João Neto, who's here with us, the president from Maceió, right?
Thank you, João. Thank you for the honor.
Come on, let's go, shall we? Let's continue. Dri, uh, tell us, okay? Well, we know that dispensing medication is an act exclusive to pharmacists.
This is something we always emphasize in all our conversations with pharmacists and with society.
But the big question is how the pharmacist, as the dispenser, can/will he be able to access the SNCR.
Explain it to us.
Okay, so let's talk about access.
So, from the moment RDC 1000 was published, it didn't specify how that access would work. It was only after the Q& A that we realized that access would be through KNES, the National Registry of Health Establishments.
When that happened, we contacted Anvisa and explained to the GPcom staff, especially Renata and Dr. Thiago, whom we have great respect and affection for, that the vast majority of pharmacies did not have KNES, and that health surveillance agencies only provided KNES to pharmaceutical establishments that performed human vaccinations or clinical analysis tests. And for them it was a surprise, because there is already a consolidated ordinance from the Ministry of Health, number 1646 of 2015, in its article 7, which states that every pharmacy establishment must have what? Is your quint correct? And so we started promoting this in all the councils across the country through the Federal Pharmacy Council, okay? Well, spreading the word about the importance of pharmacies having kines. So, the municipal secretariats started to understand that they had to release [the funds], but we were also surprised because there were many municipalities that were having this difficulty. So what did Anvisa do? She's dropping a note, okay everyone? And what she says is that this note, which they analyzed internally within Anvisa, allows them to release access through another method, correct? of the establishments. So, here's how it was decided. For private pharmacies, access will be granted through their AF, the company's operating license. Never forgetting, the pharmacy has a certificate of compliance, an operating license, and authorizations granted by Anvisa (Brazilian Health Regulatory Agency). And one of these authorizations, for the public system, will be through Kines.
Now hold it like this. The flow of access to the national revenue control system for private dispensing establishments. So, I'm talking about private events because the public continued with Kinés. For private dispensers, the following steps will be observed. Therefore, the establishment must access the new Anvisa registration, not the old one, but the new one. So, who has access to the new registration? The regulatory agent who requested your FE or your accountant, correct?
Then he accesses this new registration.
After being linked to the respective AFE (Authorization for Operation), the establishment will be automatically recognized as a dispenser and enabled for the SNCR (National System for Recycling Control). So, when you enter the AF (Animal Feeding) information in this new registration, it automatically identifies an enabled dispenser for you. In that environment within the Anvisa registration system, the person responsible for the establishment, who is the security manager, the accountant, or the regulatory agent, will be able to view the SNCR and assign the access profile that is called, for example, pharmacy. The pharmacy profile is provided to authorized collaborators. And who are these authorized collaborators, folks?
They are the pharmacists. As Luciana just said, and made very clear, it's an act exclusive to the pharmacist. And, oh, the "aos," so it's plural, so you can give the pharmacy profile on SNCR to all your pharmacists, and their access to SNCR will be through the SNCR.
So, when that pharmacist logs into the SNCR using their GOB password, they have already identified the pharmacy with the dispensing establishment and have already identified the pharmacist. And what is happening right now? This new registration system from Ambisa is experiencing a slight delay in its functionality.
Therefore, as a result, no private pharmacy has been able to do this: to integrate the AF (pharmacy safety) so that it is recognized as a dispensing environment, allowing the manager to access the SNCR (National System for Pharmacy Control) and give the pharmacy profile to the employees. And even as of today, the 22nd, this new registration doesn't have that functionality. That's why Anvisa released that statement yesterday, making it clear that as soon as this new registration is ready, these managers will take action, right? And assign a profile before you can start accessing the SNCR. ANBISA will not release the SNCR until everyone is properly registered. That's why Anvisa is taking special care to avoid doing anything hastily, so that this process can begin smoothly. We are in constant contact with Visa, assisting them and passing on all these types of situations, and we will therefore help you pharmacists by providing information from Visa so that you can stay informed.
From the moment you say, "Oh, now you can do this with the new registration," the system will start operating, right? If we can allow the dispensation, we will relay the information coming from Ambisa. For you, giving wide publicity. This will not only be the Regional Pharmacy Council of São Paulo, but it will be the Regional Council for the entire country, with the assistance of the Federal Pharmacy Council. You can rest assured about that.
And since it's an electronic prescription system, I don't print it anymore. You will keep the physical PDF. So, you keep the IT validation, you keep the electronic format that you received. So that put an end to the practice of splitting prescriptions, because when you received a digital prescription, it might include both controlled substances and antimicrobials, and you would separate the antimicrobials here, the controlled substances there. That's no longer possible, because now you have to keep this electronic document safe; there's no way to circumvent it anymore, okay everyone? And the electronic prescription, it is used only once and cannot be reused. And then a very big doubt arose. And the analogs of the antimicrobials in RDC 471 of 2021, in its article 9, which the prescriber uses for continuous use, and it allowed me to fractionate it into 30 days, 30 days, 30 days. Is that no longer possible? Because it has a unique number and is meant to be used only once. Anvisa responded: " Initially, this functionality will not be available in the SNCR." That's why, in the case of analogues or antimicrobials, the prescriber uses the term "continuous use" for up to 90 days of treatment, correct? He should use the physical prescription form, not the electronic prescription form. Perfect, guys? And every electronic prescription will have a function, whether it's a notification, a special control prescription, or a prescription regarding retention. And when the digital prescription becomes an electronic prescription, everything generated without a date will still be valid for 30 days before being dispensed.
Thank you, thank you, Adriano. Uh, I said I was going to ask 10 questions, right? The top 10 are the top 10 that arrive here for us. We also have questions and answers just like Visa does.
See, everyone?
The doctor responds verbally, right? Yeah, he replies verbally.
Well, prescription notifications depend on being accompanied by a liability waiver or a clarification form, especially for notifications in electronic format. How does the issue of terms stand? Can they also be issued electronically?
Excellent. Well, we also asked Anvisa this question because some notifications, such as the B2 prescription notification, which in this case is Cutramina, the special prescription notification for systemic retinoids, and the thalitomide prescription notification, come with specific terms. And today you saw what I told you, there, being physical, the prescriber can attach the physical term. And since it's electronic, how will that be done? So, we raised several questions on behalf of Anvisa.
Here I'm showing you the questions. Perfect. For both anorexigenic drugs and special prescription notifications, systemic thyroid, right? Regarding the issue of telindobidin. We get the answer. If the prescriber wants to generate an electronic prescription, right? An electronic document, no problem at all, it can provide a physical document, OK? The prescriber can then physically sign, the patient physically sign, and the pharmacist physically sign. But the trend will be different. Once he generates an electronic prescription, he will probably want to link the term "electronic" to that electronic prescription as well. So, if it's going to be electronic, it has to be born digital from start to finish. So, the prescriber will sign digitally, and the patient will need to sign digitally as well. And don't worry, these platforms are already adapting.
They're going to take it, they're going to insert an advanced signature on the platform, where the prescriber gets the patient's data, and create an electronic signature for them as well— not an advanced digital signature, and it doesn't have to be a government signature. Then the patient signs digitally, and when the pharmacist receives this electronic prescription along with the electronic consent form, they just need to log into the platform, register to have this advanced electronic signature, and sign digitally as well. So if he embraces the term "digital native," he'll be digitally native from beginning to end, doctor, patient, and pharmacist.
Very good, very good. But I also promised at the beginning of our live stream that we weren't just going to talk about RDC 1000, right?
We were going to talk a little bit about RDC 1015, which deals with cannabis products, right, DRI? Well, even today, as I mentioned here with you all, there was a super important congress and also RDC 1015, which came into effect on May 4th, which replaces, right, the old 327, which was revoked.
So, there have also been some very significant changes in the dispensing of cannabis products.
Well, and then many doubts arose as well, doubts arose as well, of course, right?
We haven't even fully grasped number 1000 yet, and then came number 1015 to confuse things even more. So, Dri, if you could explain a little bit about the changes that have occurred regarding the dispensing of cannabis-based medications, we would appreciate it.
So, let's go. New RDC 1015 of 2026.
It replaced RDC 327 of 2019. Perfect, everyone. So, I'm going to show you what's currently in effect. Well, it's still in the transition phase, so we say it's a mixed RDC, okay? Believe it or not. So, folks, this RDC 1015 regulates cannabis-based products. Still a cannabis-based medicine. We only have one, which is mevatilpa, multiple sclerosis. The rest is all cannabis-based product. And the cannabis-based product regulated by M15 can be cannabidiol alone or cannabidiol combined with THC. And then when it has THC, we can have two variations.
Cannabidiol with THC up to 0.2% or cannabidiol combined with THC from 0.2% to 0.3%. So we can have this variation: cannabidiol alone, cannabidiol combined with THC up to 0.2%, or THC from 0.2% to 0.3%. This is something that has evolved in relation to 327, which was only permitted orally and nasally in 327. It now includes inhalation, viral, buccal, sublingual, and dermatological applications. It expanded. And there's a very important detail here: in article 105, it says that this cannabis-based product will have a commercial name, but this commercial name doesn't yet have a regulatory act established by Anvisa (Brazilian Health Regulatory Agency). Perfect. But we'll have that soon. So, here's the mixture of 1015 and 327. For now, the prescriber will prescribe it, so let's go, shall we? Cannabidiol is on the C1 list, okay? It's list C1. So, we 're working with medications listed in Ordinance 344, okay everyone? So, this prescriber should put the name of the phytopharmaceutical, cannabidiol, 200 mg per ml, followed by the name of what? It's from the lab that he wants. It's not just 200 mg per ml of cannabidiol giving various laboratories that option. No, he has to put the name of the phytopharmaceutical along with the name of the laboratory.
Perfect. Because once he mentions only sugarcane, the prescription is incorrect, since phytopharmaceuticals are not interchangeable.
All good? And when Anvisa regulates and disciplines the issue of replacing the name of the phytopharmaceutical with the commercial name, we will also publicize it. Then companies will have a deadline to make this change. For now, it's all still under the name of phytopharmaceuticals, correct? Advertising regarding this is exactly the same as for controlled medications; you cannot advertise Aligro, only in scientific journals. And who will be able to prescribe it? Let's remember, doctors, dentists, and veterinarians are also qualified to prescribe these medications. The veterinarian may prescribe a cannabis-based product that is sold in pharmacies. But where did you read that in Law 1015, which regulates and permits it? It's not in 1015, it's within Ordinance 344. If you look at Ordinance 344 in the list and the addendum, in the addendum, at the end of all the lists, in item 12, it makes it clear: "Prescription by legally qualified veterinary professionals registered with the Federal Council of Veterinary Medicine is permitted, for medicinal purposes for exclusively veterinary use, of medicines and products and cannabis with sanitary authorization." So, folks, when we look at 105, we read doctors, surgeons, dentists, don't forget, the veterinarian will also have this autonomy to prescribe, correct?
Anvisa even released a statement regarding this, okay? On November 7th, 2024, when the old resolution was still in effect. And what changed, folks? Let's see.
From May 4th onwards, cannabis-based products, that is, cannabidiol or cannabidiol associated with THC up to 0.2%, they... It will now be prescribed with a special control prescription. Previously it was with notification B, now it will be with a special control prescription and its label will change to a red label. I said it will change, I didn't say it changes automatically.
Companies have up to 90 days to petition Anvisa (Brazilian Health Regulatory Agency) for the change of what? The packaging label. So you will be dispensing with the special control prescription for cannabis-based products still with a black label. But the mandatory special control prescription came into effect on May 4th. Cannabis-based products with THC above 0.2 up to 0.3 continue to be with notification A. So here we have the transition, okay? Everything the prescriber prescribed before the 4th, they prescribed with notification B.
Okay? From the 4th onwards, if you receive a B prescription, a notification B in your pharmacy, you can refuse it.
Why? Because since the 4th the mandatory prescription has become a special control prescription. And this transition from black label to red label, as I told you, It will take time because companies are only now starting to access the website and begin promoting this petitioning action for changes in packaging. So we will have a long period of cannabis-based products still bearing the name of the phytopharmaceutical and still with the black label.
Perfect. However, everything that was cannabediol with THC above 0.2 up to 0.3 continues to be dispensed with a prescription notification. So, at the time of dispensing, you have to inform which document you are dispensing with. Was it with notification B issued before the 4th, or with a special control prescription? This is important.
This parameterization also did not change anything regarding the instructions we have to give to the patient, especially regarding cognitive impairment, correct? The informed consent form is still in duplicate, one copy in the medical record, the other with the patient. At the pharmacy, they only need to present the special control prescription or the prescription notification A when the cannabis-based product has THC between 0.2 and 0.3. Perfect. And it is controlled by the SNGPC. Because it's part of Ordinance 344. It belongs to list C1 and its manipulation is permitted, okay everyone? Based on phytopharmaceuticals, * Cannabis sativa L.* Note only with cannabidiol. You cannot manipulate cannabidiol with THC.
Perfect. They only allowed the base of cannabis sativa L. But also, in the same way, there is still no regulatory standard to determine how this manipulation should be done for compounding pharmacies.
Perfect, Dri. Thank you very much for clarifying 1015 for us as well. And I want to talk a little with you all before thanking Dr. Adriano here. Look, we are making our Instagram available.
You can also contact us, ask questions directly, okay?
We are available for you because we know how much you need help at this moment. And I also want to offer you a gift.
Every May 20th, the CRF launches, sorry, every On the 20th of each month, the CRF (Regional Pharmacy Council) releases a new training course on our virtual academy, which is accessible to all pharmacists in Brazil, from all CRFs, São Paulo and all the others. And on May 20th, we made available an exclusive training course on RDC 1000 of 2025, recorded here by Dr. Adriano for all pharmacists in Brazil. So, access it through ECAT CRF, the address is in the comments, so you can access the Virtual Academy and take this complete course.
And then, as Anvisa (Brazilian Health Regulatory Agency) updates the data, Dr. Adriano will update it there as well. This live session is recorded for you on the YouTube channel, you can access it there, and that's also where we will answer your questions. The Virtual Academy also offers this course, which is a gift for you so you can feel a little more confident in your daily work. I also want to make it available to... Pharmacists in São Paulo, because you need to access our channel to get in touch with our guidance department. So, for pharmacists registered here in São Paulo, you have a super important channel available: the DOF, the Pharmaceutical Guidance Department. And if the people here who help us can also put the guidance email address on the screen, which is [email protected], you can access it, send any questions you want. It's a department, a completely free service for you, where we have Dr. Daniela Verissimo, who coordinates this department, and several other pharmaceutical inspectors, also specialists in legislation, to help you.
Well, so you have all these channels so you can interact with us. And now I want to thank Dr. Adriano Falvo immensely, who accompanied us until now, gave us many explanations, even though we still have many doubts, Adriana!
You still have a lot of work ahead of you, but I want you to know that you can count on us with all our support. The board of directors, with all these tools, allows us to continue working together and doing a good job, continuing to serve the entire Brazilian population well and collaborating with the public health of our country, and especially with the safe and rational use of medications, which is our banner, the banner of the CR RF and the banner of all pharmacists here in Brazil. Well, then, good evening everyone. Thank you very much for joining us so far. We still have over 400 pharmacists present at 9:10.
So, a little bit went by, you know? When I said I was going to record, I had to have a few beers beforehand, Adriana, on this Friday. Oh, you said it would be recorded. People F.
Yes, but only a little bit went by.
Thank you, everyone. Thank you for being here with us on this cold Friday night, at least in São Paulo.
We're freezing here. And count on us. Thank you again. I hope you enjoyed it and please answer our satisfaction survey to help us improve even more for you. A big hug. All the best. Okay.
Good work and success to you all every day. Bye, everyone. Adriano, thank you, everyone. Once again, we're here. It's a great obligation of this organization to bring this information to you, pharmacists in the state of São Paulo, but we're talking about all of Brazil. Whenever we have news, we bring it to you. So, follow us, and you can be sure we'll do a new live stream and send it through our channels. That's why it's so important for you to follow us so we can always send you updated information. Thank you very much. Good night and God bless you. That's it. Good night, everyone. Thank you.
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