19.1. General considerations
The extraction, production, manufacturing, processing, synthesis, purification, fractionation, packaging, repackaging, importation, exportation, storage, and shipment of medicines, drugs, pharmaceutical ingredients, and related products are subject to health surveillance regulations in Brazil.
For the purposes of this study, “related products” are defined as any substance, product, device, or accessory that cannot be classified as a drug, medicine, or pharmaceutical ingredient, but whose use or application is related to the defense and protection of individual or public health, personal or environmental hygiene, or diagnostic and analytical purposes, including cosmetics and perfumes, as well as dietary products, optical products, medical acoustic, dental, and veterinary products.
It should be borne in mind that the public health surveillance regulations that form part of the Brazilian public health legal framework are matters of public order and are based on the police powers granted to public health authorities at all levels, particularly at the federal level.
Likewise, health actions and services are considered matters of public importance, and the government must be responsible for their regulation, inspection, and oversight. Although health is a right of all and a duty of the State, the implementation of health actions and services is entrusted not only to the State but must also be carried out through private-law legal entities. It is, therefore, a complex and highly regulated sector.
19.2. National Health Surveillance System
The National Health Surveillance System comprises federal, state, and municipal units and consists of the following entities: the Ministry of Health, the National Health Surveillance Agency (ANVISA), the National Council of State Health Secretaries (CONASS), the National Council of Municipal Health Secretaries (CONASEMS), the State, Federal District, and Municipal Health Surveillance Centers (VISAS), the Central Public Health Laboratories (LACENS), the National Institute for Health Quality Control (INCQS), the Oswaldo Cruz Foundation (FIOCRUZ), and the State, District, and Municipal Health Councils.
At the federal level, the main functions of the National Health Surveillance System consist of defining national health surveillance policy; regulating, controlling, and inspecting products, substances, and services of interest to public health; conducting health surveillance at ports, airports, and borders— , a function that may also be carried out by the states, the Federal District, and the municipalities—; monitoring and coordinating state, district, and municipal health surveillance activities; providing technical and financial cooperation to the states, the Federal District, and the municipalities; to act in special circumstances posing a risk to health and to maintain a public health surveillance information system, in cooperation with the states, the Federal District, and the municipalities.
The activities entrusted to the National Health Surveillance System are carried out at the federal level by the Ministry of Health—with regard to the formulation, monitoring, and evaluation of the national health surveillance policy and the general guidelines of the National Health Surveillance System—by the National Health Surveillance Agency (ANVISA), and by other agencies and entities of the Federal Executive Branch whose areas of activity are related to the system.
Let us therefore focus on the role of ANVISA—the National Health Surveillance Agency—which is responsible for regulating the pharmaceutical market in Brazil.
19.3. ANVISA—National Health Surveillance Agency
ANVISA, a federal autonomous agency operating under a special regime—a regulatory agency characterized by administrative independence, the stability of its leadership during their terms of office, and financial autonomy—is affiliated with the Ministry of Health and has as its institutional mission to promote the protection of public health, through health oversight of the production and marketing of products and services subject to health surveillance, including the environments, processes, inputs, and technologies related to them, as well as the control of ports, airports, and borders.
ANVISA’s role, within the context of the administrative decentralization of a typical public administration service, is justified above all by the need for specialization in providing a public service of such magnitude in order to achieve better results.
Among the agency’s responsibilities are the coordination of the National Health Surveillance System; the promotion and conduct of studies and research within the scope of its responsibilities; proposing, monitoring, and implementing health surveillance policies, guidelines, and actions; establishing norms and standards regarding limits for contaminants, toxic residues, disinfectants, heavy metals, and other substances that pose a health risk; temporary intervention in the administration of production entities that are financed, subsidized, or maintained with public funds, as well as in service providers and/or exclusive or strategic producers for the supply of the domestic market; administration, and collection of the public health surveillance inspection fee; the granting and revocation of operating authorizations for companies that manufacture, distribute, and import products subject to public health surveillance; approval of the import and export of such products; the granting of product registrations for the commercialization of such products; the granting and revocation of certificates of compliance with good manufacturing practices; the closure, as a public health surveillance measure, of facilities used for the manufacture, control, import, storage, distribution, and sale of products and the provision of health-related services, in the event of a violation of relevant legislation or an imminent health risk; the prohibition of the manufacture, import, storage, distribution, and marketing of products and raw materials in the event of a violation of relevant legislation or an imminent health risk; the monitoring and auditing of state, district, and municipal agencies and entities that are part of the National Health Surveillance System, including official health quality control laboratories; the coordination and implementation of quality control for goods and products subject to health control and inspection; the regulation, control, and inspection of products and services that pose a risk to public health or of special health quality monitoring programs; and the issuance of notices of violation and imposition of penalties in the event of a violation of health laws and regulations.
ANVISA’s scope of control and inspection includes medications for human use, their active ingredients, and other inputs (drugs or raw materials, additives, or complementary substances of any nature intended for use in medications, where applicable, and their containers), processes, and technologies; food, including beverages, bottled water, their ingredients, packaging, food additives, and limits on organic contaminants, pesticide residues, and veterinary drug residues; cosmetics, personal hygiene products, and perfumes; sanitizers intended for cleaning, disinfection, or pest control in residential, hospital, and communal settings; diagnostic kits, reagents, and supplies; medical, hospital, dental, and blood therapy equipment and materials, as well as laboratory and imaging diagnostic equipment and materials; immunobiologicals and their active substances, blood, and blood products; human and veterinary organs and tissues for use in transplants or reconstructions; radioisotopes for in vivo diagnostic use, as well as radiopharmaceuticals and radioactive products used in diagnosis and therapy; cigarettes, cigarillos, cigars, and any other smokable product, whether or not derived from tobacco; and any products that pose a potential health risk, whether obtained through genetic engineering, by another procedure, or exposed to radiation sources.
For legal purposes, a pharmaceutical product intended for prophylactic, curative, palliative, or diagnostic purposes is considered a drug.
19.4. Health Surveillance Fees
Individuals and legal entities engaged in the manufacture, distribution, and sale of products, as well as the provision of services subject to health surveillance, are considered taxpayers for this tax.
The taxable event for the Health Surveillance Inspection Fee is the performance of acts within the jurisdiction of the National Health Surveillance Agency (ANVISA), such as the granting of marketing registrations, operating authorizations, approvals, inspections, and the issuance of certificates and forms, among others.
The collection and enforcement of the Health Surveillance Fee may be delegated to the states, the Federal District, and the municipalities, at ANVISA’s discretion; provided that any tax not paid on time will be collected, through administrative or judicial proceedings, with interest, fines, and surcharges in lieu of a judgment against the debtor for attorney’s fees.
19.5. Registration of Pharmaceutical Products
The manufacture, marketing, or display for sale of medicines, drugs, pharmaceutical inputs, and related products must be preceded by a marketing authorization in the form of a health registration granted by the Ministry of Health, through ANVISA; it is understood that any modification to the formula, change in the composition or quantities of ingredients, addition, subtraction, or innovation introduced in the product’s formulation must be submitted in advance to the health authority for prior and express authorization, under penalty of registration cancellation.
In this regard, it is worth noting that the importation, sale, display for sale, storage, and distribution of a product without registration, when required; in violation of the formula specified in the registration; without the identity and quality characteristics required for their commercialization; with reduced therapeutic value or activity; of unknown origin; or purchased from an establishment without a license from the health authority—constitute a crime against public health, which is also considered a heinous crime.
A drug may not be registered if its composition contains a substance that is not recognized as clinically or therapeutically beneficial.
Drugs, medicines, and pharmaceutical supplies that contain narcotic substances or cause physical or psychological dependence, as well as medicines in general, will only be registered or have their registrations renewed if their packaging complies with the standards approved by the Ministry of Health.
The health registration is valid for ten years throughout the national territory and may be renewed for equal and successive periods, subject to the rules and exceptions set forth in the applicable regulations. Since 2020, the general rule for drugs has been a ten-year validity period, currently governed by RDC 912/2024. In the case of previously unapproved generic drugs prioritized under the terms of RDC 204/2017, the 365-day period for marketing provided for in the regulations applies. Under this prioritization criterion, applications for which the reference drug is protected by a patent with a validity period exceeding 300 days, counted from the date of filing, are not classified as priority cases, except in the circumstances provided for in the regulation.
Both registration and its renewal are only effective upon publication in the Federal Official Gazette.
It is important to note that, under penalty of forfeiture, the renewal of the registration must be requested by the registrant no earlier than twelve months and no later than six months prior to the registration’s expiration date; the registration is automatically considered renewed if no decision has been issued by the health authority by the time of its expiration.
The registration of drugs, medicines, pharmaceutical inputs, and related products, in addition to meeting specific requirements, is contingent upon scientific and analytical evidence demonstrating that the product is safe and effective for its intended use and that it possesses the necessary identity, activity, quality, purity, and safety.
Furthermore, the registration applicant may be required to submit pharmacoeconomic information to the health authority, such as the price the company charges for the product in other countries, the cost of acquiring the active ingredient, the cost of treatment per patient using the product, the potential number of patients to be treated, the price list the company intends to charge in the domestic market—with a breakdown of the tax burden—a breakdown of the product’s marketing proposal, including projected expenses for sales efforts and advertising, the price of the modified product—in cases of a change in formula or dosage form—and a list of all substitute products available on the market, along with their respective prices.
Evidence that a particular product, previously considered safe, is harmful to health or does not comply with public health legislation must result in its withdrawal from the market and the requirement to alter its formulation and the wording on labels, package inserts, and packaging, under penalty of registration cancellation and product seizure.
1 RDC 912/2024.
2 Article 3, paragraphs 2 and 4, of ANVISA RDC 204/2017.
19.6. Registration of New Drugs
Under the terms of RDC 753/2022, a new drug is one that contains a new molecule, defined as a new active pharmaceutical ingredient (API) or an analog API considered a new chemical entity in Brazil. An innovative drug is one that features a new combination, a new single-ingredient drug, a new route of administration, a new concentration, a new dosage form, new packaging, a new therapeutic indication, or some other innovation compared to a new drug already registered in Brazil.³
A company interested in obtaining a health registration for a new drug must provide the health authority with comprehensive information regarding its composition and use, so that the authority may assess its nature and determine its level of safety and efficacy.
New drugs intended exclusively for experimental use under medical supervision are exempt from registration and may even be imported with the express authorization of the Ministry of Health. It should be noted, however, that this exemption is valid only for a period of three years, after which the product must be registered, under penalty of seizure ordered by the Ministry of Health.
In Brazil, the general requirements for the regulatory approval of drugs for human use are set forth in RDC 948/2024, and for synthetic and semisynthetic drugs classified as new, innovative, generic, and similar, in RDC 753/2022. The evaluation of the dossier essentially covers aspects of quality, safety, and efficacy. The safety and efficacy evaluation of new and innovative synthetic and semisynthetic drugs is conducted by the Safety and Efficacy Evaluation Division (GESEF) of the General Directorate of Medicines (GGMED) at ANVISA.
The quality analysis—which involves a review of documentation and the technical report—consists of verifying all stages of the product’s manufacturing process, from the procurement of materials, through production, quality control, release, storage, and shipment of finished products, as well as related controls.
Efficacy and safety analyses are conducted through the evaluation of nonclinical and clinical studies, as applicable, including post-marketing pharmacovigilance data when available and relevant.
It is worth noting that the approval of studies involving new drugs or health products not yet registered in Brazil, developed and manufactured within the country, will be granted upon submission of the documentation required by a specific regulatory act, accompanied by a notification of the manufacture of special batches intended exclusively for clinical research when the study involves a drug not yet approved in Brazil.
3 Reference drug – an innovative product registered with the federal agency responsible for health surveillance and marketed in the country, whose efficacy, safety, and quality have been scientifically proven to the competent federal agency at the time of registration
19.7. Registration of Generic Drugs
A generic drug can be defined as a drug similar to a reference or innovative product, intended to be interchangeable with the reference drug, generally produced after the expiration or waiver of patent protection or other exclusive rights, with its efficacy, safety, and quality proven, and always designated by the DCB (Brazilian Common Name—the name of the drug or pharmacologically active ingredient approved by the federal health authority) or, in the absence thereof, by the INN (International Nonproprietary Name—the name of the drug or pharmacologically active ingredient recommended by the WHO—World Health Organization).
It is important to note that the following will not be accepted for registration as generic or similar drugs: biological products, immunotherapeutics, human plasma and blood derivatives; herbal medicines; specific drugs; homeopathic remedies; drugs subject to simplified notification; hospital-use antiseptics; diagnostic products and radiological contrast agents; radiopharmaceuticals; and medical gases.
A company seeking to obtain a health registration for a generic drug must submit the documentation required by applicable regulations, including proof of pharmaceutical equivalence and, as applicable, bioequivalence studies or documentation demonstrating eligibility for a bioexemption.
Based on the legal concept of a reference drug—which is the innovative drug duly registered and marketed in Brazil, whose efficacy, safety, and quality were scientifically proven at the time of registration—the innovative drug generally serves as the reference drug; however, in its absence, ANVISA is responsible for designating one.
A bioequivalence study involves comparing the bioavailability of the test drug and the reference drug under similar experimental conditions, with the aim of demonstrating their equivalence, in accordance with the technical requirements established by ANVISA.
19.8. Registration of Similar Drugs
A similar drug is one that contains the same active ingredient(s), has the same concentration, dosage form, route of administration, dosage, and therapeutic, preventive, or diagnostic indication as the reference drug registered with the federal agency responsible for health surveillance; it may differ only in characteristics related to the product’s size and shape, expiration date, packaging, labeling, excipients, and vehicles, and must always be identified by brand name.
The registration of a similar drug is subject to evaluation and approval by ANVISA, provided that the applicable health requirements are met. The similar drug, whether manufactured in Brazil or abroad, must have its efficacy, safety, and quality proven in accordance with current regulations.
The registration of a generic drug, as well as that of other drugs, will be declared expired if renewal is not requested during its final six-month validity period. Furthermore, if the drug has not been marketed for at least a period corresponding to the final two-thirds of the registration’s validity period, the registration will not be renewed.
In the event of the registration’s expiration, an application for a new registration may be filed two years after verification of the fact that led to the expiration of the previously granted registration, unless such expiration is attributable to the company in question.
A company seeking to obtain a health registration for a similar drug must submit to the health authority a certificate of pharmaceutical equivalence, a dissolution profile certificate, and a dissolution method development report, just as required for the registration of generic drugs. However, these documents need not be submitted if the similar drug is manufactured at the same facility, using a formulation, production process, and equipment identical to those used in the manufacture of the reference drug.
To obtain registration, proof of bioequivalence or documentation demonstrating eligibility for a bioexemption must also be submitted, as applicable, in accordance with the applicable technical requirements.
If the pharmacokinetic parameters of the test drug and the reference drug indicate a need for adjustment, the product’s formulation may be modified until they are compatible. If the company chooses not to modify the formulation, it must propose a dosing regimen that ensures safety and efficacy if the pharmacokinetic curves fall below the safety limit or exceed the therapeutic limit. In this case, the drug will be a product resulting from a change in pharmacokinetic properties; it will be exempt from the requirement to submit a clinical study and cannot be a reference product.
In the case of a similar drug consisting of drug combinations, or two or more dosage forms in the same package for concomitant or sequential use, proof of the relative bioavailability of each active ingredient in the formulation compared to the reference drug will be required.
One of the main differences between generic drugs and similar drugs is that the former are identified by the DCB or, in its absence, by the DCI, while the latter are identified by brand name or trade name. Interchangeability is established in relation to the respective reference drug; there is no automatic interchangeability between a generic drug and a similar drug.
19.9. Operating Authorization
Obtaining a marketing authorization for the product from the regulatory authority is not the only legal requirement for companies seeking to engage in any type of economic activity related to products subject to health surveillance. In fact, in addition to health registration, such companies must obtain an operating authorization from ANVISA and must be licensed by the health agency of the Federal Units in which they are located.
Registration pertains to the product, while the license applies to the facility, and the operating authorization pertains to the company’s operations. The operating authorization is granted upon fulfillment of the legal, technical, and administrative requirements set forth in the applicable health regulations.
The Operating Authorization (AFE) is, therefore, an act within ANVISA’s jurisdiction, granting authorization for the operation of companies, establishments, institutions, and agencies, subject to compliance with the technical and administrative requirements of the health regulations in force, in accordance with, among other applicable regulations, RDC 16/2014.
The AFE is required of every company that engages in the storage, distribution, packaging, shipping, export, extraction, manufacturing, fractionation, import, production, purification, repackaging, synthesis, processing, and transportation of drugs and pharmaceutical ingredients intended for human use, cosmetics, personal hygiene products, sanitizing perfumes, and the bottling or filling of medical gases. The AFE is specific to each activity, and a company is not permitted to engage in activities not covered by the registration it has obtained.
Companies that engage in the activities listed above but handle substances subject to special control or medicines containing such substances must obtain a Special Authorization (AE).
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The technical requirements that drug manufacturers must meet to obtain an operating authorization are: (i) facilities, equipment, and technical apparatus that are necessary and in proper working order for their intended purpose, including qualifications and calibrations; (ii) an established quality system; (iii) a clearly defined validation and qualification policy, in cases where required by the specific Good Manufacturing Practices (GMP) standard; (iv) utility systems supporting the production process that are in a condition suitable for their intended purpose; (v) hygiene, storage, and operating conditions appropriate to the product’s needs, so as to reduce the risk of contamination or changes to its characteristics; (vi) personnel trained to perform production, quality control, quality assurance, and other support activities; (vii) means for the inspection and quality control of the products it manufactures, including specifications and analytical methods; (viii) standard operating procedures and other necessary documents completed and approved; (ix) means capable of eliminating or reducing pollutants resulting from the manufacturing process that cause harmful effects on health; and (x) evidence of compliance with the project development plan up to, at a minimum, the project input data definition phase, for manufacturers of health products.
Importers, distributors, warehouses, carriers, exporters, and repackagers must comply with the following technical requirements: (i) existence of a) facilities, equipment, and technical apparatus necessary and in proper working order for their intended purpose, including qualifications and calibrations; (ii) the availability of qualified and properly trained human resources to perform the activities of the company or facility, including, in the case of a drug importer, ensuring drug quality, investigating quality deviations, and other support activities; (iii) hygiene, storage, and operating conditions appropriate to the product’s needs, in order to reduce the risk of contamination or alteration of its characteristics; (iv) standard operating procedures for the receipt, identification, inventory controls, and storage of finished, returned, or recalled products; (v) a self-inspection program, specifying its scope, frequency, responsibilities for implementation, and actions to be taken in the event of nonconformities; (vi) a separate, identified, and restricted-access area for the storage of products or substances subject to special control; (vii) an inventory control system that enables the issuance of periodic inventory reports; (viii) a formal system for investigating quality deviations and the preventive and corrective measures adopted after identifying the causes; (ix) an established quality system; (x) a waste management plan; (xi) adequate receiving and shipping areas protected against weather variations; (xii) mechanisms to ensure that suppliers and customers are duly registered with the competent health authorities, where applicable; and (xiii) for carriers, a list of the number and identification of company-owned or third-party vehicles under their responsibility, made available for transport, which must be equipped with the necessary equipment to maintain the specific transport conditions required for each product subject to health surveillance.
Furthermore, the licensing by the local authority of industrial or commercial establishments engaged in such activities will depend on the company having been authorized to operate by the Ministry of Health—through ANVISA—and on each establishment meeting the technical and health requirements established in the regulations and instructions of the Ministry of Health, including those regarding the effective supervision of qualified technical personnel in the various sectors of activity. Furthermore, each establishment must hold a specific and independent license, even if there is more than one in the same locality belonging to the same company.
It should be emphasized that the operating authorization issued by the federal health authority will authorize the company to operate throughout the national territory and must be renewed whenever there is a change in the specific activity for which it was granted.
It is also worth noting that the following acts constitute a health violation: extracting, producing, manufacturing, processing, preparing, handling, purifying, dividing, packaging or repackaging, importing, exporting, storing, shipping, transporting, purchasing, sell, transfer, or otherwise use food, food products, medications, drugs, pharmaceutical ingredients, dietary products, hygiene products, cosmetics, related products, packaging, sanitizers, utensils, and devices that affect public or individual health—without registration, a license, or authorizations from the competent health agency, or in violation of the provisions of the relevant health legislation. In the event of a violation, in theory, penalties may include a warning, seizure and destruction, suspension of operations, revocation of registration, and/or a fine.
19.10. Importation of Pharmaceutical Products
The registration of drugs, medications, and pharmaceutical inputs of foreign origin will depend not only on the legal requirements common to domestic products but also on proof that they are already registered in the country of origin. Only companies authorized by ANVISA for this activity may import products subject to health surveillance; the importation of raw materials and pharmaceutical ingredients intended for the manufacture of medicines by a company that does not hold an Operating Authorization or a Special Operating Authorization, as applicable, is prohibited.
According to ANVISA RDC 637/2022, companies engaged in the manufacture, import, export, repackaging, storage, shipment, and distribution of active pharmaceutical ingredients must register them with ANVISA, subject to the exemptions provided for in the regulation.
Goods classified as drugs, food, cosmetics, hygiene products, perfumes, sanitizers, medical devices, and in vitro diagnostic products—whether in the form of finished products, in bulk or as semi-finished products, intended for commerce, industry, or direct consumption, must have their import authorized provided they are formally compliant with the National Health Surveillance System regarding the mandatory requirements—as applicable—for registration, notification, filing, model authorization, registration exemption, or any other form of control regulated by ANVISA.
Health authorization for the importation of goods by an individual or legal entity shall be granted only upon compliance with technical and administrative guidelines and submission of an application, either electronically or manually, as provided and regulated by ANVISA.
On an emergency or temporary basis, considering the international epidemiological context—whether involving humans, animals, or plants—or the implementation of public health programs related to the health control of goods and of individuals or legal entities involved in the manufacturing and service provision processes for the importation of goods and products subject to health surveillance, the health authority may prohibit the importation or entry of products subject to health surveillance.
The granting of an Import License by ANVISA shall entail the inspection of the goods prior to customs clearance or delivery for the purposes of display or human consumption, at the discretion of the health authority or whenever so required.
19.11. Labeling and Advertising of Pharmaceutical Products
Advertising, in any form of dissemination and through any medium, of products subject to health surveillance may only be conducted after authorization by the Ministry of Health. As will be seen below, the principle of transparency, which underpins consumer rights, is widely upheld by ANVISA in the regulation and oversight of pharmaceutical advertising.
In this regard, in the case of drugs, medications, or any other product required to be sold by medical or dental prescription, advertising shall be restricted to publications intended exclusively for distribution to physicians, dentists, and pharmacists.
The labeling or advertising of products subject to health surveillance may not include designations, geographic names, symbols, figures, drawings, or any indications that could lead to misinterpretation, error, or confusion regarding the origin, source, nature, composition, or quality of the product, or that attribute to the product purposes or characteristics different from those it actually possesses.
The following practices are expressly prohibited: advertising drugs not registered with ANVISA in cases required by law; making direct and/or indirect comparisons that are not based on information substantiated by clinical studies published in indexed journals; advertising the same drug as new more than two years after the date it first went on the market, except for new packaging formats or new therapeutic indications registered with ANVISA; causing fear or distress and/or suggesting that a person’s health will be or may be affected by not using the drug; discriminating on the basis of nationality, sex, race, religion, or other grounds; publish messages such as: “Approved,” “Recommended by an expert,” “Demonstrated in clinical trials,” or “Advertisement Approved by the Health Surveillance Agency,” the “Ministry of Health,” or a corresponding state, municipal, or Federal District agency, except in cases specifically determined by the National Health Surveillance Agency; suggest a reduction in risk, to any degree, except in cases where such a reduction in risk is explicitly stated in the approved indications or properties at the time of registration with ANVISA, and even in such cases, only in publications intended for healthcare professionals; include messages, whether verbal or nonverbal, that misrepresent the actual indications of medications registered with ANVISA; attribute curative properties to a drug when it is intended—as per its ANVISA registration—solely for the symptomatic treatment and/or management of chronic diseases; suggest the absence of side effects or adverse effects, or use expressions such as “harmless,” “safe,” or “natural product,” except in cases registered with ANVISA.
Any type of advertising, publicity, or promotion of a drug directed at the general public must be conducted in a manner that makes the promotional nature of the message evident.
Communications directed at healthcare professionals, whether conveyed through mass media, verbally, or nonverbally, are considered advertising and must comply with legal requirements.
In the advertising, promotion, and marketing of over-the-counter drugs, the following practices are prohibited: encouraging and/or inducing the indiscriminate use of drugs and/or the use of dosages and indications not listed in the drug’s registration with ANVISA; including messages of any kind directed at children or adolescents, as well as using symbols and images for this purpose; promoting or organizing contests, promising or offering financial incentives or prizes contingent upon the sale of medicines; suggesting or encouraging diagnoses by recommending a corresponding treatment, with the sole exception of phrases or images that define, in scientific or lay terms, the medicine’s indication for isolated symptoms; claim that a drug is “safe,” “without contraindications,” “free of side effects or risks of use,” or use equivalent expressions; claim that the medication is a food, cosmetic, or other consumer product, just as no food, cosmetic, or other consumer product may be presented or appear to be a medication; exploit illnesses, injuries, or disabilities in a grotesque, abusive, or misleading manner, whether or not they result from the use of medications; claiming and/or suggesting that a drug is superior to another by using expressions such as: “more effective,” “less toxic,” “the only possible alternative within the category,” or using expressions such as: “the product,” “the top choice,” “the only one,” “the most frequently recommended,” “the best”—these expressions may only be used if supported by scientific evidence and previously approved by ANVISA—; stating and/or suggesting that a medication is superior to another by using expressions such as: “more effective,” “better tolerated”—these expressions may only be used if supported by scientific evidence and previously approved by ANVISA—; using direct or indirect language linking the use of a medication to a person’s physical, intellectual, emotional, or sexual performance, or to their beauty, except when such properties have been approved by ANVISA; suggesting that the medication has pleasant organoleptic characteristics such as: “tasty,” “delicious,” “delightful,” or equivalent expressions.
In the specific case where the name and/or image of a professional is mentioned to endorse the advertised properties of the medication, the advertising message must include the name of the professional involved, along with their registration number with the respective professional council or other professional registration body.
Quotations, tables, or other illustrations taken from scientific publications and used in any advertisement, publicity, or promotion must be faithfully reproduced and must specify the complete bibliographic reference.
In the case of generic drugs, in accordance with Law 9.787/99 and its regulations, the following phrase must be included: “generic drug – Law 9.787/99.”
Pharmaceutical company representatives must provide accurate and complete information about the drugs they represent during advertising, promotional, and marketing activities directed at healthcare professionals authorized to prescribe and dispense medications.
In their promotional, advertising, and marketing activities, representatives must limit themselves to the scientific information and characteristics of the drug registered with ANVISA.
It is prohibited to grant, offer, or promise prizes, monetary benefits, or benefits in kind to healthcare professionals authorized to prescribe or dispense drugs, as well as to those engaged in direct-to-consumer sales.
Sponsorship by a pharmaceutical manufacturer or distributor of any public or private events, symposia, congresses, meetings, conferences, and similar gatherings—whether partial or total—must be disclosed in all promotional materials or documents resulting from or related to the respective event.
The distribution of free samples must be done in packaging containing at least 50% of the content of the original product approved by ANVISA, intended exclusively for professionals authorized to prescribe or dispense medications, except for free samples of contraceptives and medications for continuous use, which must now contain, must contain 100% of the content of the original registered and marketed package. In the case of antibiotics, the minimum quantity must be sufficient to treat one patient.
Author: Luiz Augusto Lopes Paulino
Dannemann Siemsen
Av. Rodolfo Amoedo, 300 – Barra da Tijuca
22620-350 Rio de Janeiro- RJ
Tel.: (21) 2237 8700
E-mail: [email protected]
Av. Brigadeiro Faria Lima, 4.221 – 3º andar
04538-133 São Paulo – SP
Tel.: (11) 2155 9500
E-mail: [email protected]
Internet: www.dannemann.com.br