Pharmaceuticals and medical devices in Brazil are regulated by Federal Laws and Resolutions (known as Resoluções or RDCs) issued by ANVISA, the National Health Regulatory Agency.

Key legislation for pharmaceuticals includes:

• Law 5,991/1973, known as the Law of Sanitary Control of the Distribution and Sale of Medicines, which regulates the distribution, sale and control of medicines and related products;
• Law 6,360/1976, the primary statute for pharmaceutical products, covering production, commercialisation, advertising, labelling, quality control and penalties;
• Law 6,437/1977, which outlines penalties for violating federal sanitary statutes and regulations; and
• Law 9,294/1996, which imposes restrictions on the use and advertising of specific products.

Key legislation for medical devices includes:

• RDC 751/2022, amended by RDC 810/2023, which establishes rules for risk assessment, notification procedures, registration, labelling and use of medical devices;
• RDC 850/2024, which sets the validity term for medical device marketing approvals;
• RDC 830/2023, which establishes rules for in vitro diagnostic devices, including its instruments, complemented by IN 320/2024;
• RDC 657/2022, which regulates software as a medical device (SaMD); and
• Normative Instruction 290/2024, under the terms of RDC 741/2022, which establishes a procedure for analysing medical device registration petitions, utilising analyses by an Equivalent Foreign Regulatory Authority (AREE).

ANVISA operates independently within the Ministry of Health as the primary regulatory authority. It oversees the production, marketing and utilisation of health-related products and services, as well as supervising ports, airports and borders. ANVISA functions as a semi-autonomous agency, with administrative and financial autonomy but linked to the federal government (Ministry of Health). Oversight and budgetary control are provided by the Ministry, while ANVISA’s board of directors, composed of technical experts, makes science-based decisions regarding regulations and approvals.

Regulatory decisions in the pharmaceutical and medical field can be contested through administrative appeals, either directly to the relevant regulatory authority or via lawsuits in federal courts.

The process for filing administrative appeals against ANVISA’s decisions is governed by Law 9,784/1999, which regulates administrative procedures within the Federal Public Administration, and RDC 266/2019. ANVISA’s decisions undergo a maximum of three instances:

• first instance – decisions by Organisational Units;
• second instance – Appeals Division (Gerência-Geral de Recursos or GGREC); and
• final instance – Collegiate Board of Directors (Diretoria Colegiada or DICOL)

First instance appeals are directed against decisions issued by ANVISA’s Organisational Units and must be addressed to the authority responsible. If unresolved initially, appeals are reviewed by the General Appeals Management at the second stage and, if necessary, escalated to the Appeals Division (GGREC) and ultimately to the Collegiate Board of Directors (DICOL).

Appeals must adhere to formal requirements outlined in RDC 266/2019, Article 4 onwards, and must be submitted in writing. The deadline for appealing an ANVISA decision is 30 days from the notification date.

Similar challenges can be applied to other regulatory matters under ANVISA’s jurisdiction, such as food, cosmetics, sanitisers and tobacco derivatives.

ANVISA categorises pharmaceutical products based on their active pharmaceutical ingredient (API) and innovative characteristics as outlined in RDC 753/2022, amended by RDC 948/2024, as can be seen below:

Pharmaceutical Categorisation (RDC 753/2022)

Primarily, but not exclusively:

• reference drug – an original, rigorously tested drug approved by ANVISA;
• generic drug – a cost-effective alternative drug with the same ingredients, form and effect;
• innovative drug – a drug that features new molecules, combinations or delivery methods;
• new drug – a drug that contains previously unapproved molecules; and
• similar drug – a drug that is similar to a reference drug with minor variations.

Medical Device Categorisation (RDC 751/2022 - amended by RDC 777/2023 and 810/2023)

Categorised by use and risk:

• active medical device – operates with external energy, alters density of gravity or converts energy;
• diagnostic and monitoring device – provides information on health states;
• therapeutic device – modifies, replaces or restores biological functions;
• single-use device – used once per procedure;
• implantable device – fully or partially inserted into the body;
• invasive device – partially or fully penetrates the body; and
• in vitro diagnostic device – analyses samples for diagnostic purposes.

Risk Classification

• Class I – low risk;
• Class II – medium risk;
• Class III – high risk; and
• Class IV– maximum risk.

Clinical Trials for Pharmaceuticals

• RDC 945/2024 establishes the guidelines and procedures for conducting clinical trials in the country with the aim of subsequently granting drug registration.
• CNS Resolution 251/1997 defines regulatory and bioethical guidelines.
• CNS Resolution 466/2012 establishes general rules for clinical trials.
• RDC 505/2021 (amended by Normative Instruction 270/2023) governs clinical trials for advanced therapy medicinal products.

Clinical Trials for Medical Devices

• Law 14.874/2024 provides for research involving human subjects and establishes the National System of Ethics in Research with Human Subjects.
• RDC 837/2023 regulates medical device trials.
• RDC 751/2022 (in force but amended by RDC 777/2023 and 810/2023) defines risk classification, notification, labelling and use instructions.

Pharmaceuticals

For ANVISA approval of pharmaceutical trials, sponsors must submit a Drug Clinical Development Dossier (DDCM) as per RDC 945/2024. ANVISA’s Co-Ordination of Research and Clinical Trials department (COPEC) assesses the DDCM for sanitary risks before approval. ANVISA aims to complete its analysis within 90 days. Sponsors must also provide detailed protocols to the Research Ethics Committee (CEP) before trials commence. Imported products for human research must also obtain ANVISA approval, with sponsors maintaining responsibility for data integrity and quality, even if functions are delegated to a Clinical Research Organisation (CRO).

It is worth noting that Law 14,874/2024 establishes a new deadline of 90 days for ANVISA’s analysis of primary petitions for clinical trials with human beings.

Medical Devices

RDC 837/2023 simplified medical device clinical trials in Brazil, aligning with international standards and clarifying ANVISA approval requirements. This regulation eliminates the need for Clinical Research Process Consent and expedites approvals by consolidating documentation under a single Medical Devices Clinical Research Dossier (DICD) process. This streamlining removes the necessity for CEP opinions, simplifying paperwork. Only trials with results that could support Class III and IV medical device registration in Brazil necessitate ANVISA submission.

ReBEC (Registro Brasileiro de Ensaios Clínicos) is the official Brazilian Registry of Clinical Trials, operated by ANVISA. It is a public platform where anyone can find details about clinical trials conducted in Brazil, including study design, participant criteria and contact information.

The database contains information such as trial title, sponsor, investigational product, phase, primary and secondary endpoints, inclusion/exclusion criteria and participating research centres.

Health data is considered sensitive under National Research Ethics Committee (CONEP) Resolution 466/2012 and Law 13,709/2018, also known as the General Data Protection Law (Lei Geral de Proteção de Dados Pessoais or LGPD), mandating confidentiality for trial participants’ data in both public and private institutions.

Sponsors must document and report adverse events, especially fatal or life-threatening ones, to ANVISA electronically within seven days of becoming aware of them (RDC 945/2024).

Section II, subsections I and II of RDC 945/2024, specify that sponsors must submit annual monitoring reports on the trial drug’s progress, detailing all adverse events using subject codes. They also require a final report after the trial’s completion across all participating countries, including information on withdrawn subjects and verified adverse events.

These reports must meet the minimum requirements outlined in Article 73 for annual reports and Article 74 for final reports. The annual report should be submitted within 60 days of the annual reference date (the trial’s start date in Brazil), while the final report is due within 12 months of the trial’s conclusion.

Law 14,874/2024 also establishes that the researcher is responsible for submitting the research documentation, including any amendments, to the CEP for approval, but the reporting of adverse events continues to be ANVISA’s responsibility.

There are no specific regulations in Brazil that explicitly restrict the use of online tools for supporting clinical trials, such as for recruitment or monitoring purposes.

However, it is essential to ensure that any online tools used comply with CONEP Resolution 466/2012 and the LGPD, which clearly states that health data is considered sensitive, and confidentiality of trial participants’ data is mandatory for both private and public institutions.

Building on the discussion above, health data is considered sensitive, necessitating strict confidentiality safeguards in both private and public institutions. According to Article 5, Item II of the LGPD, sensitive personal information includes details regarding a natural person’s racial or ethnic origin, religious beliefs, political views, union or other organisational memberships, health or sex life, and genetic or biometric data.

Transferring personal data from clinical trials to a third party or affiliate is possible but subject to stricter conditions outlined in Article 11 of the LGPD.

• Specific consent – explicit and informed consent from the data subject is mandatory, clearly explaining the recipient and purpose of the data transfer.
• Limited exceptions – the LGPD permits transferring sensitive data without consent in limited circumstances, such as legal compliance or protecting the data subject’s life or safety. However, these exceptions are interpreted narrowly.

Following on from 2.5 Use of Data Resulting From Clinical Trials, data from clinical trials in Brazil faces strict data protection regulations due to its personal and sensitive nature. Before transferring such data to third parties or affiliates, explicit consent from participants, contractual agreements outlining data security protocols and potential data residency restrictions must all be considered.

Article 4 of RDC 751/2022 (in force but amended by RDCs 777/2023 and 810/2023) regulates the classification of medical devices as any instrument, apparatus, equipment, implant, in vitro diagnostic medical device, software, material or other article, intended by the manufacturer to be used, alone or in combination, in human beings, for some specific medical purpose, and whose principal intended action is not achieved by pharmacological, immunological or metabolic means in the human body, but which may be aided in its intended action.

For a product to be classified as a pharmaceutical (regarding Law 10,742/2003), it should be any pharmaceutical product, technically obtained or prepared, for prophylactic, curative, palliative or diagnostic purposes.

Biologic products often involve complex manufacturing processes and unique safety considerations compared to traditional chemical drugs. Therefore, obtaining marketing authorisation for biologics in Brazil typically involves additional requirements beyond those for chemical drugs.

Comprehensive Dossier

Detailed information about the biologic product must be submitted to ANVISA. This dossier typically includes:

• product characteristics;
• manufacturing information;
• non-clinical studies – data from pre-clinical studies (in vitro and in vivo) assessing the product’s safety and potential efficacy;
• clinical studies – data from well-designed and controlled clinical trials in humans to demonstrate the product’s safety and efficacy for the intended use; and
• risk management plan – a comprehensive plan outlining potential risks associated with the product and strategies to mitigate those risks.

Comparability Studies

For biosimilars (biologics that are similar to an already approved reference product), additional comparability studies demonstrating similarity to the reference product in terms of quality, safety and efficacy are often required.

Stricter Regulatory Requirements

Compared to chemical drugs, biologics might face stricter regulatory requirements related to manufacturing process controls, product characterisation and ongoing monitoring of safety post-marketing.

Additional Considerations

• Foreign clinical trials – clinical trials conducted outside Brazil might be accepted by ANVISA under certain conditions. However, specific requirements regarding data integrity and compliance with Good Clinical Practices must be met.
• Post-marketing surveillance – marketing authorisation holders are typically required to conduct post-marketing surveillance to monitor the safety and efficacy of their biologic product in the real-world setting.

The following are some of the main resolutions that relate to biological products.

• RDC 55/2010 (in force but amended by RDC 948/2024) regulates the registration of new biological products and biological products.
• RDC 913/2024 regulates post-registration changes and cancellation of registration of biological products.
• RDC 412/2020 establishes the requirements and conditions for conducting stability studies for the purposes of registration and post-registration changes to biological products.

Marketing authorisations for pharmaceuticals and medical devices are valid for ten years from the date of their publication in the Brazilian Official Gazette (DOU). They can be renewed for successive ten-year periods.

Certain requirements must be met for renewal, for example, for medicines, the product must have been marketed for at least 80 months (two-thirds) of the ten-year period (120 months).

For medical devices, for example, revalidation of the registration must be requested no more than 12 months and no less than six months before the registration expires.

The registration of a product which is subject to health surveillance may be cancelled in the following situations.

• When the renewal of the product’s registration has not been requested within the period specified by ANVISA.
• When it is proven that the product or manufacturing process may present a risk to the health of the consumer, patient, operator or third parties involved.
• When a request from the holding company is made when it no longer has any interest in marketing the product.
• When a request from the holding company is made when the registration is to be transferred to another company.

In addition, ANVISA can take preventive measures to protect public health during a health risk assessment. These measures, authorised by Law 6,360/1976, Law 9,782/1999 and Law 9,784/1999, include inspection actions such as seizure, recall, prohibition and suspension of activities relating to the product or service in question (storage, marketing, distribution, manufacture, import, advertising and/or use).

Furthermore, ANVISA can utilise precautionary measures, which are also proactive administrative actions based on the terms of Law 6,437/1977. These measures aim to safeguard public health in situations of imminent risk, even before a formal hearing with the party involved. For example, a precautionary interdiction can be applied when there is clear evidence of product alteration or adulteration.

Once a health investigation is completed and an infraction is confirmed, ANVISA initiates the process of charging the responsible party. Penalties for sanitary infractions, as defined in Law 6,437/1977, can be applied individually or in combination.

The process for obtaining marketing authorisation for pharmaceuticals and medical devices in Brazil is overseen by ANVISA.

What follows is a summary of the steps.

• Pre-application:
1. compile all necessary data and documentation; and
2. evaluate risk classification and seek pre-submission consultations with ANVISA.
• Formal application:
1. submit a comprehensive dossier electronically through ANVISA’s online platform.
• Technical evaluation:
1. ANVISA experts assess safety, efficacy and quality; and
2. inspections of manufacturing facilities or clinical trial sites may be conducted.
• Decision and issuance:
1. ANVISA issues a final decision approving or rejecting. It is also possible that it may request further information for making such decision; and
2. if approved, ANVISA issues a marketing authorisation document.

Variations to marketing authorisation:

• similar process, but typically less extensive; and
• complexity depends on the nature of the change: minor, moderate or major.

Transfer of marketing authorisation:

• eligibility is limited to specific corporate operations such as mergers or successions;
• procedures are outlined in RDC 903/2024;
• deadlines vary by product category; and
• no other changes are permitted in the transfer petition.

Steps for submitting a registration transfer request:

• petitioning;
• fees;
• protocol;
• statement of the corporate or commercial transaction carried out, as set forth in Annex I of RDC 903/2024;
• a certified copy of the operating licence or sanitary permit issued by the competent authority, updated to reflect the corporate or commercial change; and
• monitoring

Important points:

• the registration number follows a specific formation process; and
• the validity of the registration remains the same regardless of the transfer publication date.

In Brazil, patient access to pharmaceuticals and medical devices typically requires ANVISA’s marketing authorisation. However, exceptions exist.

• Clinical trials – patients can join strictly regulated trials for new products. This requires informed consent.
• Compassionate use programmes – eligible patients with life-threatening conditions and no alternatives may access unapproved products under strict criteria:
1. eligibility – determined on a case-by-case basis;
2. physician request – detailed justification submitted to ANVISA;
3. ANVISA approval – evaluation based on risks and benefits; and
4. limited availability – access granted from a limited supply, often from the manufacturer.

Compassionate use is not guaranteed, and ANVISA holds final approval authority.

The regulations concerning the obligation on the marketing authorisation for pharmaceuticals and medical devices are summarised below.

Pharmaceuticals (Medicinal Products)

Marketing authorisation (MA) process

• RDC 31/2014 (in force but amended by RDC 438/2020) defines procedures for obtaining an MA in Brazil, including documentation requirements and evaluation timelines.
• ANVISA (National Health Surveillance Agency) oversees the process.
• Phases include pre-clinical studies, clinical trials (Phases I-III) and post-marketing (Phase IV) studies.

Pharmacovigilance obligations (medicinal products)

RDC 658/2022 establishes General Guidelines for Good Manufacturing Practices for Medicines.

Post-marketing obligations

Phase IV trials may be imposed to monitor real-world safety and efficacy.

Medical Devices

RDC 751/2022 (in force but amended by RDC 777/2023 and 810/2023) regulates the risk classification, notification and registration regimes, labelling requirements and instructions for use of medical devices.

• Technovigilance obligations – manufacturers must actively participate in technovigilance.
• Post-marketing obligations – similar to pharmaceuticals, ongoing safety assessment is crucial.

The following are some resolutions regarding the control, inspection and monitoring of products and services:

• RDC 67/2009 (in force but amended by RDC 702/2022) – technovigilance standards applicable to health product registration holders in Brazil.
• RDC 551/2021 – obligation for registration holders to carry out and report field actions, meaning actions of a health product with the aim of reducing the risk of an adverse event related to the use of the health product already on the market of health products in Brazil.
• RDC 665/2022 – Good Manufacturing Practices for Medical Products and Diagnostic Products for In Vitro Use.

In the realm of third-party access to pharmaceutical and medical device authorisations, regulation is governed by the Information Access Law (Law 12,527/2011). Despite the sensitivity and confidentiality of health products, interested third parties can request access to registration information under this Law.

Article 7 states that access to information includes obtaining data from records or documents produced by relevant bodies or entities, whether stored publicly or not, as well as information concerning public asset administration, resource usage, bidding and administrative contracts.

However, it is important to note that while all information regarding a registered health product may be requested, it may not always be provided by regulatory agencies such as ANVISA or the Chamber for the Regulation of the Medical Market (CMED).

The primary regulation safeguarding commercially confidential and individual-related information is the “secrecy law” (Lei do Sigilo). Additionally, trade secrets benefit from specific legislation protection, crucial for preserving proprietary knowledge and fostering competitiveness and innovation.

To safeguard trade secrets effectively, companies should implement practical measures:

• identification and classification – recognise and appropriately classify information deemed as trade secrets;
• access control – limit access to authorised personnel only;
• contracts and agreements – incorporate confidentiality clauses in contracts with partners, suppliers and employees;
• physical and digital security – implement measures to protect electronic documents and data physically; and
• training and awareness – educate employees on the significance of confidentiality and trade secret protection.

In Brazil, the regulatory framework foresees routes for expediting the registration of medicines and medical devices. The optimisation of the registration proceedings has recently been enhanced by new rules regarding regulatory reliance enacted between 2022 and 2024. Additionally, for medical devices, the issuance of authorisations can be faster for products classified as Group 1 or 2 based on their risk level.

Pursuant RDC 751/2022, the category of medical devices is divided into four groups.

• Group 1 and 2 – classified as low risk. These devices are required to be notified to ANVISA, following a simplified process that demands the submission of fewer documents (on average, three documents).
• Group 3 and 4 – classified as high risk. For these devices, a full registration procedure is required with ANVISA, involving the submission of more comprehensive documentation (on average, five documents).

Regarding importation, there is a distinction between registered and notified medical devices. Imported medical devices subject to registration require the submission of proof of registration, a certificate of free sale or equivalent document, issued by the competent authority of the country of manufacture and sale, as well as a declaration from the legal manufacturer. On the other hand, notified medical devices only require the declaration issued by the legal manufacturer.

Finally, it is important to point out that in vitro medical devices have their own specific regulations, as set out in RDCs 830/2023 and 848/2024. Although they follow the same regulatory process of notification or registration, the documentation required for these devices differs from that applicable to others.

Brazil has embraced the notion of regulatory reliance. With RDC 741/2022, ANVISA recognises assessments by Equivalent Foreign Regulatory Authorities (AREEs). Normative Instructions (IN) 289/2024 and (IN) 290/2024 detail the procedures for utilising these assessments. IN 289/2024 applies to medicines, biological products, vaccines and active pharmaceutical ingredients, while IN 290/2024 specifically addresses medical devices.

The applicable AREEs for each sector are as follows.

Medicines, biological products and vaccines:

• European Medicines Agency (EMA);
• Health Canada;
• Swissmedic;
• Medicines and Healthcare products Regulatory Agency (MHRA);
• US Food and Drug Administration (FDA);
• Therapeutic Goods Administration (TGA); and
• World Health Organization (OMS)

Active Pharmaceutical Ingredients:

• World Health Organization (OMS); and
• European Directorate for the Quality of Medicines & HealthCare (EDQM)

Medical Devices:

• Australian Therapeutic Goods Administration (TGA);
• Health Canada (HC);
• US Food and Drug Administration (FDA);
• Japan Ministry of Health, Labour and Welfare (MHLW).

Brazil makes use of regulatory decisions of other jurisdictions to optimise its product registration procedures. Therefore, if a company has already obtained authorisations from internationally recognised jurisdictions, the issuance of ANVISA’s authorisations can be expedited. The analysis conducted by AREE can be accepted for the purpose of implementing an optimised analytical procedure facilitated by regulatory trust practices, such as collaborative work and mutual or unilateral recognition. The practice of the optimised analysis procedure will be based on the instructional documentation prepared by the Equivalent Foreign Regulatory Authority, as established in specific normative acts.

For the purposes of adopting the optimised analysis procedure, the instructional documentation of the Equivalent Foreign Regulatory Authority must:

• prove that the product subject to the instructional documentation is essentially identical to the one submitted for evaluation by ANVISA;
• have been prepared using standards consistent with those used by ANVISA, to ensure it has the same scope; and
• be presented in its complete form, including the questions and guidelines that were made during the analysis by the Equivalent Foreign Regulatory Authority, unless excepted in specific normative acts.

Both pharmaceutical and medical device manufacturing facilities in Brazil need a licence to operate, known as an Autorização de Funcionamento (AFE), issued by ANVISA.

The procedure for obtaining an AFE is outlined in RDC 16/2014 (in force but amended by RDC 860/2024).

• Registration – the company and product must be registered with ANVISA.
• Documentation – detailed documentation should be submitted describing manufacturing processes, quality control measures and plant layout, complying with Good Manufacturing Practices (GMP) regulations (RDC 658/2022 for pharmaceuticals and specific RDCs for medical devices).
• Inspection – ANVISA conducts a facility inspection to verify compliance.
• Approval – If compliant, ANVISA issues the AFE.

Activities authorised by the AFE include manufacturing, storage of raw materials and finished products, and quality control procedures.

The AFE has no expiry date.

Additional notes:

• while a GMP certificate is not mandatory for the AFE, facilities must adhere to ANVISA’s Good Manufacturing Practices.
• documentation requirements and inspections may vary based on product complexity and risk classification; and
• for certain products such as electrical medical devices, breast implants, rubber gloves and sterile disposable syringes, an INMETRO certificate confirming compliance with Brazilian standards is necessary.

Wholesale distributors of pharmaceuticals and medical devices in Brazil must be licensed by ANVISA. The Authorisation to Operate Pharmacies and Drug Stores (AFE) permits the sale of industrialised medicines, including those under special control per Regulation SVS/MS 344/1998 and updates.

The application process, outlined in RDC 16/2014, Article 28, requires the submission of technical and formal documentation.

Once granted, the AFE for Wholesale allows commercialisation of various products such as medicines, pharmaceutical inputs, health products, cosmetics, personal hygiene items, perfumes and disinfectants between legal entities or to professionals.

The AFE has no expiry date.

As mentioned in 1.3 Different Categories of Pharmaceuticals and Medical Devices, ANVISA categorises pharmaceutical products based on their API and innovative characteristics, as outlined in RDC 753/2022.

Law 6,360/1976 is the primary pharmaceutical law, governing production, marketing, advertising, labelling, inspection, quality control, penalties, importation and marketing authorisation of medicines, drugs, active ingredients and medical devices. Decree 8,077/2013 regulates it.

To secure marketing authorisation for medicinal products, the applicant must be an authorised manufacturer or importer. ANVISA authorisation is mandatory for manufacturing/selling pharmaceuticals and/or importing them before market entry.

Various government agencies enforce import regulations for pharmaceuticals and medical devices.

• National Health Regulatory Agency (ANVISA):
1. oversees health product import/export; and
2. sets specific technical requirements/procedures via resolutions/directives.
• Federal Revenue Department (Secretaria da Receita Federal do Brasil):
1. manages customs control at Brazilian borders; and
2. collaborates with ANVISA to verify import documents, classify goods and collect duties/taxes.
• Ministry of Agriculture, Livestock and Supply (MAPA):
1. participates in importing specific agricultural/veterinary medical devices; and
2. collaborates with ANVISA on import procedures for these products.
• National Institute of Metrology, Standardisation and Industrial Quality (INMETRO):
1. involved in importing certain medical devices meeting technical standards; and
2. may require additional certifications/conformity assessments to meet Brazilian specifications.

In Brazil, only a local legal entity can serve as the importer of record for pharmaceuticals and medical devices. Specific requirements must be met.

Eligible importer of record:

• Brazilian legal entity – registered with the relevant commercial registry. This includes subsidiaries of foreign companies or wholly Brazilian-owned companies; and
• foreign company with a branch office – a foreign company can be the importer if it has a duly established and registered branch office in Brazil.

Importer of record requirements:

• valid CNPJ (National Registry of Legal Entities) – the company must possess a valid CNPJ, a unique identification number for Brazilian legal entities;
• qualified technical professional – the importer must employ a qualified technical professional responsible for the imported products, possessing relevant qualifications;
• permanent establishment – maintaining a physical establishment in Brazil with proper infrastructure for storage and distribution to ensure supply chain traceability; and
• ANVISA registration – the importer must be registered with ANVISA, allowing verification of regulatory compliance and import management capacity.

In Brazil, importing pharmaceuticals and medical devices requires prior authorisation from ANVISA.

Key regulations, including RDC 810/2023 amending RDC 751/2022 (in force with amendments), cover risk classification, notification, registration regimes, labelling requirements and usage instructions for medical devices. Additionally, RDC 18/2014 regulates communication to ANVISA regarding temporary or permanent discontinuation or reactivation of medicine manufacture or import.

Import Authorisation (AI) requirement:

• commercial imports typically require an AI from ANVISA;
• importers must apply for the AI before the shipment reaches Brazil; and
• ANVISA assesses applications and supporting documents to ensure product registration, technical compliance and adherence to GMP.

Exemptions may apply in certain cases.

• Donations – importing for public health programmes as donations may be exempt from AI, subject to specific ANVISA procedures and documentation.
• Emergency situations – temporary authorisations may be granted during public health emergencies.
• Clinical trials – authorised trials have specific import procedures for investigational drugs and medical devices.
• Personal use – limited exemptions may exist for small quantities for personal use, but travellers should verify guidelines with ANVISA or Brazilian customs to avoid penalties.

Brazil’s non-tariff regulations and restrictions (NTRs) for imports, including pharmaceuticals and medical devices, ensure product safety, quality and compliance.

Basis for imposing NTRs:

• Harmonised System (HS) Tariff Code – determines NTR requirements based on product classification;
• technical description – product characteristics can dictate NTRs; eg, medical devices may need extra certifications; and
• regulatory category – ANVISA’s classification influences NTRs, with high-risk products facing stricter regulations.

Laws and regulations listing products subject to NTRs:

• Law 13,097/2015 – governs import/export of health products, outlining ANVISA’s role;
• ANVISA resolutions and directives – specify technical requirements, registration and import processes for different product categories; and
• other legislation – additional regulations from ministries such as MAPA or INMETRO may apply.

Brazil engages in trade agreements with provisions for trade and regulatory facilitation. Some include the following.

Trade Bloc

Mercosur was formed in 1991 with Argentina, Uruguay, Paraguay and associate members such as Bolivia, Chile, Peru, Suriname and Guyana. Mercosur promotes trade integration via tariff reductions and regulatory harmonisation.

Free Trade Agreements (FTAs)

Brazil has FTAs with various countries:

• Uruguay and Paraguay (Mercosur);
• Argentina (Mercosur);
• Bolivia (Mercosur);
• Chile;
• Paraguay (bilateral);
• Israel;
• Palestine;
• Egypt; and
• South Africa

Trade/Regulatory Facilitation Provisions

FTAs often include the following. 

• Mutual Recognition Agreements (MRAs) – recognising each other’s testing and certification procedures to reduce redundant testing.
• Harmonisation of technical standards – aligning regulations and standards to simplify compliance.
• Streamlined customs procedures – speeding up customs clearance and reducing paperwork.
• Transparency and information sharing – enhancing regulatory transparency and information exchange for smoother trade in regulated goods.

Brazil imposes price controls on pharmaceuticals and medical devices through CMED, regulating prices, fostering competition and setting price ceilings.

Key laws include:

• Law 10,742/2003 – establishes CMED and modifies previous legislation; and
• Decree 4,937/2003 – defines criteria for drug price adjustments.

Medical devices undergo economic monitoring per RDC 478/2021, with Normative Instructions 84/2021 and 119/2022 outlining monitoring details.

Drug Price Approval

The process involves submitting economic data and proposed prices based on drug categories outlined in CMED’s Resolution 2/2004.

CMED’s decision is subject to appeals, with final decisions potentially reviewed by federal courts.

Drug Price Categories (Resolution 2/2004)

• Categories I-VI – classify drugs based on novelty and therapeutic benefit, each with specific pricing rules.
• Omissive category – for drugs not fitting established categories.

Appealing Price Decisions

Companies can challenge CMED decisions internally and through federal courts if legal grounds exist.

Drug Price Classification

CMED classifies approved drug prices into three categories.

• Factory price (PF) – maximum price for companies selling drugs to pharmacies and the government.
• Maximum consumer price – highest price pharmacies can charge consumers.
• Maximum selling price to the government – price resulting from applying a mandatory discount (PAC) to the PF. The PAC is adjusted annually.

Price Adjustments and Industry Concerns

Annual price adjustments, criticised for lagging behind inflation, affect drug pricing, though actual market prices often fall below set ceilings, especially for generics.

International reference prices indirectly influence drug pricing in Brazil, particularly in Category I, where they play a significant role. Resolution 2/2004 establishes a price basket comprising nine countries, serving as a benchmark for evaluating manufacturer prices, excluding taxes.

Category I, for new patented drugs offering substantial benefits, is directly influenced by international prices. The proposed PF cannot exceed the lowest PF practised for the same product in the basket of countries, ensuring competitive market entry.

However, drug pricing in Brazil is influenced by factors beyond international prices.

• Product characteristics – novelty, therapeutic benefit and patent status influence pricing.
• Cost-effectiveness analysis – companies must demonstrate the drug’s cost-effectiveness compared to existing treatments.
• Public health needs– CMED may prioritise public health considerations, setting prices below international levels.

Brazil’s healthcare system blends public and private financing for drugs.

Public System (SUS)

• SUS prioritises essential healthcare and medication access for citizens.
• SUS is government-funded to ensure universal health access (Article 196 of the Constitution).

Drug acquisition:

• public bidding – transparent, cost-effective drug procurement via public bidding;
• government may purchase patented drugs without bidding;
• productive development partnerships – strategic drug partnerships with private firms ensure reliable supply at set prices; and
• technology incorporation (CONITEC):
1. evaluates new technology inclusion into SUS based on evidence and cost-effectiveness;
2. stakeholder submissions undergo CONITEC review and final recommendation; and
3. Law 14,313/2022 allows SUS reimbursement for off-label drug uses upon CONITEC approval.

Private System (Health Insurance)

Health insurance coverage:

• ANS oversees private health insurance, defining mandatory coverage; and
• ANS’s List of Procedures mandates drug coverage based on contracted plans.

List of procedures:

• ANVISA authorisation – only ANVISA-approved drugs are included; and
• the list is updated every two years to include new technologies.

Judicialisation:

• lawsuits ensure access to drugs not covered by SUS or private plans;
• Constitutional guarantee (Article 196) supports patient access, especially for rare diseases or cannabis-based products.; and
• Supreme Court guidelines consider ANVISA approval, alternative treatments and unreasonable delays in drug evaluation.

Brazil employs cost-benefit analysis (CBA) within Health Technology Assessment (HTA) processes for pharmaceuticals and medical devices, though its direct influence on pricing and reimbursement decisions varies.

HTA process and CBA:

• CONITEC manages Brazil’s HTA process, considering factors such as clinical effectiveness, safety, budgetary impact, ethics and societal/public health effects; and
• CBA evaluates technology costs against expected health benefits.

Impact on pricing:

• while CBA informs negotiations for essential drugs on the RENAME list, it is not decisive; and
• government considers affordability, production costs, R&D expenses and reasonable profit margins, with international prices as negotiation benchmarks.

Impact on reimbursement:

• CBA heavily influences reimbursement decisions by SUS;
• SUS prioritises interventions with favourable cost-benefit ratios, ensuring significant health benefits at justifiable costs; and
• high-cost, low-benefit technologies may not be reimbursed by SUS.

Limitations of CBA:

• CBA complexities and uncertainties arise in calculating long-term health benefits and costs; and
• quantifying ethical considerations and improved quality of life in economic terms can be challenging.

Brazil has implemented regulations to oversee physician prescribing and pharmacy dispensing, aiming to ensure rational medication use and control pharmaceutical spending.

The Federal Council of Medicine and ANVISA provide guidance.

• The Federal Council of Medicine offers guides for medical prescriptions.
• ANVISA’s RDC 44/2009 (RDC current with amendments) outlines Good Pharmaceutical Practices for pharmacies.

Prescription regulations:

• only licensed physicians and dentists may prescribe medications;
• prescriptions must adhere to a standard format set by the Ministry of Health;
• stricter rules govern controlled substances prescriptions; and
• electronic prescriptions, while not yet mandatory, are increasingly being utilised.

Pharmacy regulations:

• only licensed pharmacists may dispense medications, ensuring proper prescription verification;
• pharmacists may substitute generics for brand-name drugs with patient consent;
• pharmacies must retain dispensed prescriptions for record-keeping; and
• some medications are available over the counter, with pharmacists providing guidance on usage and interactions.