Pharmaceutical advertising regulation and medical device advertising in Brazil

The main legal source regarding the advertising of medicines and medical devices in Brazil is Law No. 6360/1976 ("Health Surveillance Law"), which provides for the health surveillance to which medicines, drugs, pharmaceutical and related inputs, cosmetics, sanitizers and other products are subject. The Health Surveillance Law is regulated by Decree 8077/2013 ("Regulatory Decree"). 

Other legal sources related to the subject are Law No. 9782/1999 ("Anvisa Law"), which, among other provisions, establishes the National Health Surveillance Agency ("ANVISA"); Law No. 9294/1996, which provides for restrictions on the use and advertising of medicines, among other products, ("Law on Medicines Advertising Restrictions"), regulated by Decree No. 2018/1996; Law No. 8078/90, which provides for consumer protection rules ("Consumer Defense Code"); and Law No. 6437/1977, which establishes the violations of the health surveillance laws and the respective sanctions and penalties ("Health Surveillance Sanctions Law"). 

It is worth noting that ANVISA’s Board of Directors Resolution No. 96/2008 (RDC No.96/2008 - which provides for advertising, publicity, information and other practices directed to the publicity or commercial promotion of medicines) defines advertising and publicity as the set of information and persuasion techniques and activities aimed at disclosing knowledge, making a certain product or brand better known and/or more prestigious with the purpose of influencing the public through actions directed at promoting and/or inducing the prescription, dispensation, purchase and use of medicines ("Advertising"), further providing a non-exhaustive definition of the concept of "ad", as "each of the elements produced for an advertising or sales promotion campaign, with their own roles and characteristics, which follow the specificity and language of each outlet. Examples: ad, insert, film, spot, jingle, poster, billboard, panel, sign, display, folder, banner, mobile, outdoor, busdoor, visual aid, etc."

Complementary, advertising by doctors is further regulated by the Resolution of the Federal Council of Medicine (CFM Resolution No. 1974/2011 - "Medical Advertising Manual"), which, as of March 11, 2024, will be revoked and replaced by CFM Resolution No. 2236/2023 ("New Medical Advertising Manual")" and CFM Resolution No. 2217/2018 ("Medical Ethics Code "), both enacted by the Federal Council of Medicine. 

Finally, so as to be very clear, we are only considering herein specific regulations to medicines and medical devices, and not analyzing regulations from the perspective of personal hygiene products, cosmetics, dermocosmetics and/or perfumes, for instance. 

1.1 Medicines 

Just to better understand the terms, medicines are defined in Brazil (in general) as pharmaceutical products, technically obtained or prepared for prophylactic, curative, palliative or diagnostic purposes, pursuant to article 4(II) of Law 5991/1973 ("Medicines"). 

In addition to the abovementioned rules, other provisions applicable to the advertising of medicines are set out in resolutions issued by ANVISA, such as RDC No. 60/2009, as amended by RDC No. 768/2022, which provides for the production, dispensing and control of free medicine samples. 

1.2 Medical devices 

Also for a better understanding of the terms, it is important to clarify that medical devices/medical products are defined in Brazil (broadly) as any instrument, apparatus, equipment, implant, in vitro diagnostic medical device, software, material or other article, intended by the manufacturer to be used in human beings, jointly or severally, for any of the following specific medical purposes, and which main intended action is not achieved by pharmacological, immunological or metabolic means in the human body, but which may be aided in its intended action by such means: (ii.a) disease diagnosis, prevention, monitoring, treatment (or relief); (ii.b) injury or disability diagnosis, monitoring, treatment or repair; (ii.c) investigation, substitution, alteration of an anatomic or  physiological or pathological process or state; (ii.d) life support or maintenance; (v) conception control or support; or, (ii.e) provision of information by means of in vitro human body sample examination, including organ and tissue donation ("Medical Devices"), according to article 4(X) of ANVISA RDC No. 751/2022, which provides for risk classification, notification and registration, and labeling requirements and instructions for the use of medical devices ("RDC No. 751/22"). 

It is worth noting that RDC No. 751/22 is not applicable to used or refurbished medical devices (regulated by the provisions of RDC No. 579/2021); customized medical devices (regulated by RDC No. 305/2019) and medical devices for in vitro diagnostics (regulated by RDC No. 36/2015 as amended by RDC No. 423/2020). 

The main regulatory rules on the advertising of medical devices are set out in the Health Surveillance Law, the Anvisa Law, the Consumer Defense Code and RDC No. 751/22 and other resolutions highlighted above.

2.1 Medicines 

Yes, in addition to to the specific legislation, there are private entities in Brazil that have their own codes of conduct, which lay down rules on Advertising in general and even on Advertising of Medicine, applicable to their respective members and associates. 

The Brazilian Advertising Self-Regulation Council ("CONAR") is one of such bodies, being a private entity maintained by the advertising industry that promotes and supervises advertising practices. CONAR has issued the Brazilian Advertising Self-Regulation Code ("CBAP") and the Digital Influencer Advertising Guidelines ("Influencers’ Guide"). Considering the recognition and importance granted to CONAR by the market, it acts as an overall advertising watchdog and regulator, and is observed and respected even beyond its members and associates. 

Other examples of private regulatory bodies are the Trade Union for the Pharmaceutical Industry (SINDUSFARMA), the Associação da Indústria Farmacêutica de Pesquisa (INTERFARMA), and the Associação Brasileira da Indústria de Medicamentos Isentos de Prescrição (ACESSA). 

2.2 Medical devices 

There are still no specific self-regulatory bodies in Brazil to regulate the advertising of medical devices. 

There is no rule that requires prior authorization or payment of fee for the advertising of medicines and medical devices, whether to the general public or to healthcare professionals. However, only medicines and medical devices duly approved by and registered with the Ministry of Health (article 58 of the Health Surveillance Law), through ANVISA, and with such registration duly published by the Union Official Gazette (DOU) (article 3 of the RDC No. 96/08 and article 12(4), of the Health Surveillance Law) may be advertised.

 Yes, Brazilian laws regulate the advertising of over-the-counter and prescription-only medicines differently. 

The general rules on advertising medicines are mainly provided in articles 1 and 21 of the RDC 96/08. However, the division of the rules between the advertising of over-the-counter medicines and prescription-only medicines is specifically set out as follows:

• The advertising of over-the-counter medicines is permitted to the general public and its basically regulated by RDC 96/08, in particular articles 22 to 26 (detailed below); and,
• The advertising of prescription-only medicines is forbidden to the general public and limited to media intended exclusively for distribution to doctors, dentists and pharmacists (article 58(1) of the Health Surveillance Law), such as journals with exclusive technical content, referring to pathologies and medicines, aimed directly and solely at health professionals qualified to prescribe and/or dispense medicines, except for magazines with socio-cultural articles and other non technical-scientific issues. The main regulations governing the advertising of prescription-only medicines are established in articles 27 to 32 of RDC 96/08 (as detailed below). 

In addition to general rules, RDC 96/08 includes the following provisions, which are important in this analysis:

• Manipulated Medicines: Information related to manipulated medicines must comply with the provisions of articles 36 and 37, without prejudice to any other rules;
• Pharmaceutical sales rep’s visits: must comply with the rules set out in article 38; and,
• Advertising at Scientific Events: compliance with the provisions of articles 39 to 43 is mandatory. 

In addition, it is worth noting that the advertising and publicity of medicines in the context of social campaigns is forbidden, and mentioning social campaigns in medicine ads is also forbidden, according to article 44 of RDC no. 96/08. 

Nonetheless, it is also worth highlighting the provisions of articles 46 and 47 of RDC no. 96/08, which set forth that (i) the granting of a reduction in medicines price, likewise their purchase free of charges, subject to the delivery of coupons, cards or any other means or material, or the provision of any data that allows the patient’s identification, the prescribing professional, the institution to which the professional is connected or the place of prescription, is subject to regulation by the Medicines Regulation Chamber; and (ii) the materials referred to in articles 12, 13 (head of article), 18 and 39 of the RDC 96/08 wil not use any medicine-related designations, symbols, pictures, images, drawings, figurative or mixed brands, slogans or any advertising arguments. 

5.1 Medicines 

The main general restrictions to which the advertising of medicines is subject in Brazil are set out in article 8 of RDC 96/08. Thus, it is prohibited in Brazil:

• Stimulate and/or induce the indiscriminate/excessive use of medicines;
• Suggest or encourage diagnoses to the general public;
• Suggest a cure or prevention of any disease that requires treatment under medical supervision;
• Offer consumers prizes, participation in contests or similar resources that induce them to use medicines unnecessarily;
• Include images of people using the medicine;
• Encourage the general public to indulge in physical, food or alcohol excesses;
• Advertise a medicine as new two years after it was first marketed in Brazil;
• Include statements or dramatizations that induce fear or apprehension in the general public;
• Offer a refund or other benefit of any kind for the purchase of a medicine because of its possible ineffectiveness;
• Suggest that the medicine has pleasant features, such as: "tasty", "yummy", "delicious" or likely expressions or include images or pictures that refer to its taste;
• Use imperatives that directly induce the consumption of medicines, such as "have", "take", "use", "try"; e,
• Use expressions or images that may suggest that a person's health could be affected by not using the medicine. 

The advertising of medicines neither will use designations, symbols, pictures or other graphic representations, or any indications that could render the information false, incorrect, or that could lead to misinterpretation, misunderstanding, error and/or confusion regarding the true nature, composition, origin, dosage, form of use, purpose and/or characteristics of the product (article 14 of RDC no. 96/08). 

Considering Medicines that have sedative and/or drowsy effects, as per article 17 of RDC 96/08, the ad must include the warning: "(the medicine trade name or, in the case of Over-The-Counter Medicines, the active ingredient) is a medicine ". Do not drive vehicles or operate machinery while using such product, as your agility and attention may be impaired". 

Without prejudice to the above conditions, it is worth highlighting (i) the express prohibition included in article 10 of RDC 96/08, which forbids the participation/use of medicines in loyalty programs rolled out/created by pharmacies and drugstores; and, (ii) the prohibition from advertising medicines during breaks in television shows aimed at children and adolescents, as per the Law n.º 8.069/1990 (“Statute of the Child and Adolescent”). 

Considering that the advertising of medicines for the general public will mandatorily concern over-the-counter medicines, it is worth emphasizing, in addition, the provisions of article 26 of RDC 96/08:

• Using expressions such as: "Shown in clinical trials", "Scientifically proven";
• Suggesting that the medicine is the only alternative treatment, implying that healthy lifestyle habits and/or consulting a doctor are superfluous;
• Featuring the name, image and/or voice of a lay person in medicine or pharmacy, which characteristics are easily recognized by the public due to their celebrity, claiming or suggesting they use the medicine or recommending its use;
• Using direct or indirect language linking the use of the medicine to excess alcohol or food intake;
• Using direct or indirect language relating the use of a medicine to a person's physical, intellectual, emotional or sexual performance or beauty, except when these are medicinal properties approved by ANVISA;
• Present abusive, misleading or frightening visual representations of changes to the human body caused by illness or injury;
• Include messages, symbols and images of any kind directed at children or adolescents, as classified in the Statute of the Child and Adolescent. 

On the other hand, as according to Brazilian regulations the advertising of prescription-only medicines may only be directed to a specific health professional audience, we will not indicate specific prohibitions in this topic.

5.2 Medical Devices

There is no specific provision regarding limitations to the advertising of medical devices according to their target audience. 

Anyway, it is worth noting that, in case a warning message must be broadcast to prevent health risks involving a medical device, the so called “field actions”, the registration holder of the medical device will notify ANVISA in advance of the action to be adopted (article 9 of RDC 551/2021), and present ANVISA with the messages that will be broadcast; the media that will be used; the times and duration of the broadcast, which must be appropriate to the audience and the product to be targeted by the action. 

To clarify, field actions are actions carried out by manufacturers or holders of product registration for health to reduce the risk of occurrence of adverse events related to the use of the product for health already marketed. 

In any case, depending of the medical device and of the advertising’s content, the advertising of medical devices should be aimed at the general public or health professionals. 

Advertising to healthcare professionals is related to the advertising of prescription-only medicines. Considering prescription-only medicines, in addition, the advertising will be limited to media intended exclusively for distribution to doctors, dentists and pharmacists. 

Notwithstanding, pursuant to the provisions of the sole paragraph of article 29 of the RDC 96/08, the medication package insert published on the internet, without restricted access, must be up-to-date and faithfully reproduce what was approved by Anvisa, and not include any medicine-related designations, symbols, pictures, drawings, images, slogans or any other advertising arguments.\ 

The advertising of prescription-only medicines under special control via prescription notice or prescription withholding will only be made in exclusive journals with technical content concerning pathologies and medicines, aimed directly and solely at health professionals qualified to prescribe and/or dispense medicines, excluding magazines with socio-cultural material and other non technical-scientific issues (article 32 of RDC no. 96/08). This advertising of prescription-only medicines under special control is permitted insofar as it is a true copy of a technical-scientific article about the active ingredient of the medicine published in already mentioned technical-scientific journals, specifying the full bibliography, as well as in visual aids for the exclusive use of the pharmaceutical sales rep and medicine monographs. 

Advertising directed to healthcare professionals refers to the Advertising of Prescription-only Medicines. Considering Prescription-only Medicines, in addition to the duty to comply with all the general requirements and other applicable restrictions, the RDC No. 96/08 also provides for additional information to be indicated, with a font size of at least two millimeters, as follow:

• Trade name of the medicine, if any;
• Name of the active ingredient as per the Brazilian Nonproprietary Name - DCB and, failing that, the INN or botanical nomenclature, which must be at least 50% the size of the trade name;
• Anvisa registration number, including at least nine digits;
• Indications;
• Contraindications. When the benefits of the medicine are highlighted in the ad text, at least one contraindication and one of the most frequent medicine interactions must be highlighted with visual impact complying with the proportionality of 20% of the size of the largest font used;
• Cautions and warnings (including adverse reactions and interactions with medicines, food and alcohol);
• Dosage;
• Medicine classification with regard to prescription and dispensing;
• Printing date of the printed ads;
• Vaccine ads must also include information on the number of doses required for full immunization. 

In addition to these points, the advertising aimed at healthcare professionals (advertising of prescription-only medicines) will also observe that (i) internet ads will be accessible exclusively to professionals qualified to prescribe or dispense medicines by means of an electronic registration system, and a Pharmaceutical Medicine Liability will be included informing about legal restrictions of access (article 29 of RDC no. 96/08); (ii) prescription medicine package leaflets published on the internet, without restricted access, will be up-to-date and faithfully reproduce the package leaflets approved by ANVISA and will not include any designations, symbols, pictures, drawings, images, slogans or any other medicine-related advertising claims (sole paragraph of article 29 of RDC no. 96/08. 

Without prejudice to the points above with regard to the information disclosed in the Ad, in articles 30 and 31 of RDC no. 96/08 also establish that:

• Any scientific-related statements, quotes, tables or illustrations will be taken from clinical studies published in scientific journals, preferably with evidence levels I or II and will be faithfully reproduced and and the bibliography will be specified;
• The creation of graphs, charts, tables and illustrations of mechanisms of action to convey information that is not produced in scientific studies will rigorously express the veracity of the information and the full bibliography must be specified.
• The graphs, tables and illustrations of such mechanisms of action must be truthful, accurate, complete and unbiased, and will not be presented in such a way as to lead into error or confusion about the characteristics of the medicine through visual impact.
• Statements concerning the bioavailability and bioequivalence of the active ingredients will be based on studies issued by qualified laboratories and approved by ANVISA, provided that they are duly referenced and available on the company's website and the Customer Services. 

It is a primary requirement in all ads that their content is properly and clearly identified as an advertising content, in accordance with the principle of transparency and consumers’ right to information. 

Without prejudice to such specific conditions, as those related to the advertising of medicines that have sedating and/or drowsy effects, or else comparative advertising, for example, we detail below the content for Over-The-Counter Medicines ads to the General Public. 

8.1 Medicines

Medicine ads to the general public comprise over-the-counter medicines can only be made as provided in article 7 of Law 9294/1996. 

Under the Law on Medicines Advertising Restrictions, the Advertising of Medicines will observe the following:

• Medicine Ads in the media will include warnings about the harm of Medicines under phrases established by the Ministry of Health (article 7(4)), spoken and written whenever possible;
• Anodyne Medicines and Over-The-Counter Medicines will include abuse warnings (article 7(1));
• Medicine ads neither will include statements that cannot be scientifically proven, nor testimonials from non legally qualified professionals (article 7(2)); and,
• All Medicine Ads will include a warning stating that if any symptoms persist, a doctor should be consulted (Article 7(5)). 

Medicines that contain substances banned by the World Anti-Doping Code will include warning with this information on their labels, package leaflets and advertising materials, under Law 14806/2024. 

Also, RDC no. 96/08 sets forth other conditions that must be observed when advertising over-the-counter medicines to the general public:

• The bibliographical content quoted in advertising or publicity of Over-The-Counter Medicines will be made available by the company in its Consumer Service (SAC) and in the helpdesk for professional prescribers and dispensers of medicines (article 3(3)).
• Trade name of the Medicine, if any;
• Name of the active ingredient according to the Brazilian Nonproprietary Name - DCB and, failing that, the INN or botanical nomenclature, which must be at least fifty percent (50%) the size of the trade name;
• ANVISA Registration Number, with at least nine digits, except for radio advertising;
• In the case of simplified medicine notices, the following phrase: "SIMPLIFIED MEDICINE NOTICE RDC Anvisa Nº......../2006. Operating License - AFE nº:..........................", except for radio advertising;
• The indications;
• Printing dates of the Ads;
• Information that can be scientifically proven (article 7 of RDC no. 96/08) 

As per article 6 of RDC no. 96/08, the required information, when displayed in writing, will be presented in colors that contrast with the ad background, will be displayed in the predominant ad reading direction and will have to be immediately visible, keeping the proper distance proportions, indispensable for legibility and clearness. Considering advertising or publicity broadcast on television, in case the written information is not uttered it will be displayed for long enough to be read. 

Finally, for the advertising of overall medicines, the following is permitted:

• the use of anatomical pictures, in order to guide the health professional or patient to correctly use the product;
• Information about the taste of the medicine;
• expressions such as: "safe", "effective" and "quality", jointly or independently, as long as they are complemented by phrases that justify the veracity of the information, which must be based on studies published in scientific journals and be duly referenced;
• the use of expressions such as "absolute", "excellent", "maximum", "optimal", "perfect", "total" related to the efficacy and safety of the medicine, when faithfully reproduced from studies published in scientific journals and duly referenced;
• whenever included in the properties approved by Anvisa upon the registration of the medicine, inform that the medicine can be used by any age group, including through images (RDC no. 23/2009);
• whenever determined by Anvisa, include messages such as: "Approved", "Recommended by a specialist", "most frequently recommended" or "Advertising Approved by the Health Surveillance", "by the "Ministry of Health", or an equivalent message referring to a similar State, City or Federal District body;
• mentioning the number of countries where the medicine is marketed and/or manufactured, as long as the countries are identified in the ad. 

In the case of generic medice, article 16 of the RDC 96/08  states advertising will include the phrase: "Generic Medicine - Law No. 978799". It is worth noting that, as per article 7(4), of the Law on Medicines Advertising Restrictions, over-the-counter medicines may be advertised in ad campaigns sponsored by the Ministry of Health and at establishments authorized to dispense them, indicating the reference medicine. 

8.2 Medical Devices

In addition to complying with other Advertising rules and general principles of the Consumer Defense Code, the Health Surveillance Law, the Anvisa Law and the Brazilian Advertising Self-Regulation Code - CBAP, RDC 751/22 establishes that any communication or advertising of medical devices on the market will be in strict compliance with the information submitted to ANVISA by the medical device application or registration holder (article 32). 

Despite not using the same expression in other quotes, RDC no. 96/08 defines "Scientific Material" as scientific articles published in technical books. There are no specific legal or regulatory definitions for the term "scientific data" that determines the basic information that will support the advertising. 

Considering a free definition based on market practices we may understand scientific data as technical records obtained from technical research, studies and/or analyses, published as dissertations, theses, articles, etc. in specialized journals, which may be verified.  

In this context, besides observing any further rules of the Resolution, articles 30 and 31 of RDC no. 96/08 stand out, presenting specific data-related rules that should be used to support the Advertising of Prescription-only Medicines:

• Any scientific information-related statements, quotes, tables or illustrations must be taken from clinical studies published in scientific journals, preferably with evidence levels I or II and must be faithfully reproduced and the bibliography must be specified;
• Graphs, charts, tables and illustrations of mechanisms of action created to convey information that is not produced in scientific studies must strictly express the veracity of the information and the full bibliography must be specified.
• Graphs, tables and illustrations of mentioned mechanisms of action must be truthful, accurate, complete, non-biased, and and will not be presented in such a way as to lead to error or confusion about the characteristics of the medicine through visual impact; e,
• Statements concerning the bioavailability and bioequivalence of active ingredients will be based on studies issued by qualified laboratories and approved by ANVISA, provided that they are duly referenced. 

In addition, Article 7 of RDC no. 96/08 provides that any information on medicines must be scientifically proven, and Item 3 of Annex I of the Brazilian Advertising Self-Regulation Code - CBAP states that references to studies, whether scientific or consumer studies, must always be based on research that has been carried out and interpreted correctly. 

Furthermore, as will be mentioned below, considering comparative advertising, the respective data supporting the comparison must be published in scientific journals with recognized evidence levels.            

Yes, the comparative advertising of medicines is allowed in Brazil, as long as it is based on data extracted from comparative studies duly published in scientific journals, preferably with recognized evidence levels (evidence I or II), and which full bibliography is specified (article 15 of RDC no. 96/08). 

Considering the comparison between medicine prices, comparative advertising will be primarily, but not exclusively:

• directed to the general public, if between interchangeable Medicines, according to article 11 of RDC no. 96/2008.
• restricted to prescribing professionals, in the case of price comparison between non-interchangeable medicines, based on marketing information and provided that the Medicines have the same active ingredient, as per article 11(1) of RDC no. 96/2008;
• Cannot comprise medicines classified as biologic, even if they have the same indication, pursuant to article 11(3) of RDC no. 96/2008. 

Without prejudice to the specific provisions, it is worth highlighting the general rules set out in the Brazilian Advertising Self-Regulation Code - CBAP, specifically in article 32 on comparative advertising. 

The advertising of over-the-counter medicines may be made on the Internet to the general public, provided that the requirements set out above are met, including with regard to the exposure of the package insert of the medicinal product. 

The advertising of prescription-only medicines by internet does not modify the general rule that the content is accessible, exclusively, to professionals qualified to prescribe or dispense drugs, through an electronic registration system, a waiver of liability stating the legal restriction of access (Article 7 of RDC no. 96/08). 

The New Medical Advertising Manual (Resolution CFM Nº 2336/2023) sets forth advertising and publicity provisions that must be observed by doctors on their social networks, and which, considering the advertising of medicines, must be observed. 

Advertising of Medical Devices on the internet and on social networks can be done, provided that it keeps strict agreement with the information presented to ANVISA by the holder of the notification or registration. 

Without prejudice to the foregoing rules, it is worth noting that, given the need to identify the advertising nature of posts, CONAR published the Guide to the Advertising by Digital Influencers, which establishes guidelines for applying Brazilian Advertising Self-Regulation Code - CBAP rules to commercial content on social networks, determining, among other relevant points, that texts identifying the advertising as "ad", "publi" and "publipost" be inserted, as per item 1.1. 

ANVISA is the main body responsible for overseeing the compliance with the publicity and advertising of over-the-counter and prescription-only medicines by any means of communication, in addition to medicine labeling (article 68, sole paragraph, of the Health Surveillance Law), as well as for controlling, supervising and monitoring, pursuant to other health laws, the advertising of products subject to health surveillance regime (article XXVI, of Law No. 9782/1999). 

In the event of a breach of the Health Surveillance Law, the following penalties provided in the Health Surveillance Sanctions Law will be applicable, without prejudice to civil and/or criminal sanctions, such as: (i) warning; (ii) fine; (iii) seizure of the product; (iv) destruction of the product; (v) prohibition of the product; (vi) suspension of sales and/or manufacture of the product; and, (vii) deregistration of the product. 

Other entities that have the power to supervise ad-related infringements are the Public Prosecutor's Office, the consumer protection authorities and private entities, such as CONAR, regarding their respective members. 

Currently the Brazilian Congress is discussing Bill No. 4340/2020, which aims to amend the Law on Medicines Advertising Restrictions and restrict the advertising of Anodyne and Over-The-Counter Medicines to specialized journals aimed directly and specifically at health professionals and institutions, as well as provide that the advertising of Brazilian medicinal flora herbal products are subject to scientific proof of their therapeutic effects. 

Furthermore, Bill 3415/2019, which amends the Brazilian Penal Code (Decree-Law 2.848/1940) is also under discussion to increase the penalty on the sale of abortifacient medicines and amend article 10(V) of the Health Surveillance Law to include a fine ten (10) times higher than the legal minimum wage for those who advertise prohibited abortifacient medicines. 

In addition, it is part of the ANVISA Regulatory Agenda of 2024-2025 to review rules for the preparation, harmonization, updating, publication and availability of package inserts for patients and health professionals, in view of the need for alignment with international regulations, regarding the format, content, as well as forms of availability that accompany the evolution of digital technologies, including the electronic/ digital package. 

ANVISA also intends to analyze and define strategies to promote access to information necessary for the safe consumption of health products by people with visual impairment aiming at the implementation of labeling in Braille.