Medicinal Products

End-to-end support from experienced regulatory experts.

Drug Product Registration in Brazil – Overview

ANVISA - National Health Surveillance Agency is the health authority in Brazil. It protects the population against health risks arising from the use and consumption of goods and services, health supplies, as well as exposure to environmental and occupational factors, public health emergencies, and the provision of health services, through regulation, control, surveillance, and sanitary promotion.

ANVISA operates through regulatory, control, and sanitary promotion actions, within the framework of current health legislation and international best practices. These activities are supported by scientific evidence, technical capacity, and professional ethics, using a risk-based, process-oriented approach, in collaboration with federal and local health authorities, while promoting best regulatory practices.

Through its specialized areas and commissions, ANVISA plays a key role in evaluating the safety, efficacy, and quality of medicinal products, granting marketing authorizations, and overseeing the quality and safety of products available in the Brazilian market.

Classification of Medicinal Products in Brazil

Medicinal products are classified into the following categories.

  • Low-risk Medicines
  • Biologic Products
  • Dynamized Medicines
  • Specific Medicines
  • Herbal Medicines
  • Medicinal Gases
  • Generic medicines
  • New medicines
  • Advanced therapy products
  • Radiopharmaceuticals
  • Similar medicines

Medicinal Product Registration in Brazil

For a medicinal product to be registered and marketed in Brazil, ANVISA must assess the administrative and technical-scientific documentation related to its quality, safety, and efficacy.

A marketing authorization can only be applied upon request by a company legally established in Brazil and duly authorized to perform pharmaceutical activities. The company must obtain all legally required authorizations from the competent local health authority (state or municipal level) and from ANVISA to operate in Brazil.

For imported medicines, the company responsible for the importation acts as the Marketing Authorization Holder (MAH) and must comply with the regulatory requirements applicable to importers under Brazilian legislation. In addition, the product must undergo quality control release in Brazil, and importing companies must maintain their own quality control laboratory and storage facilities in the country, except where otherwise permitted under applicable regulations, provided that the established regulatory requirements are duly fulfilled. The importer remains fully responsible for ensuring the quality, efficacy, and safety of the medicinal products it imports, including legal responsibility.

An authorized user with the appropriate profile must access the ANVISA petitioning system to submit the dossier, which will then undergo regulatory review by the Agency.

A summary of the steps for medicine registration in Brazil is provided below.

A) Product Development

During this stage, extensive studies are conducted to define the pharmaceutical form and formulation most appropriate for patients.

B) Non-clinical Phase

Before a medicine is tested in humans, its pharmacological action and safety profile must be investigated in the laboratory to determine the mechanism of action, evaluate toxicity, and establish safe dose ranges and routes of administration for initial human testing.

C) Clinical Phase

Clinical trials are designed to evaluate the safety and efficacy of medicine in human subjects. These studies are conducted in different phases and may take several years to complete.

Before initiation, clinical research must be approved by ethical and technical review bodies to ensure that studies are conducted safely and in accordance with regulatory and ethical standards.

D) Submission Steps:

Once sufficient evidence of quality, safety, and efficacy has been generated, the company may submit a marketing authorization application to Anvisa.

The application must include administrative documentation, evidence of product quality, and data demonstrating safety and efficacy.

The company must also provide certification of compliance with Good Manufacturing Practices (GMP) for the manufacturing site, in addition to the applicable sanitary authorizations required.

The following steps are required to submit a new medicine application to ANVISA:

  • Identify the appropriate petition subject code based on the product classification.
  • Compile the dossier in accordance with ANVISA requirements, which may include (as applicable): Company authorizations (AFE and/or AE), Good Manufacturing Practice (GMP) certification, Quality documentation (CMC), Nonclinical and clinical data or bioequivalence studies, Equivalence studies and/or comparative dissolution profile, Pharmacovigilance information, Labeling and package insert in Portuguese, information related to API.
  • Submit the application through ANVISA’s electronic system and pay the applicable government fees.
  • After submission and payment, a protocol number will be generated.

E) Evaluation by Anvisa

ANVISA assesses the dossier for compliance with regulatory requirements related to quality, safety, and efficacy.

Also, ANVISA may issue technical queries requesting additional information. The MAH must address and submit responses within the established regulatory timeline.

F) Final decision

After the analysis, Anvisa will issue a final decision, which may be: 

  • Approval: Marketing authorization is granted, allowing commercialization in Brazil.
  • Rejection: The application is denied if requirements are not met.

Equivalence pathway (optimized procedure):

Available for products previously approved by Equivalent Foreign Regulatory Authorities (AREE), as defined by ANVISA, and that meet all requirements established by the applicable legislation. In such cases, ANVISA may consider regulatory assessments conducted by these authorities, allowing for an optimized review of the registration process.

Regardless of the documentation issued by the AREE for the purposes of the optimized procedure, the applicant must submit all technical and legal documentation required by the applicable health regulations, except for the exceptions provided in specific regulations.

Notification

Some medicines may be subject to regularization through a simplified notification procedure under specific ANVISA regulations. In these cases, they do not require approval from the health authority but a notification before beginning commercialization. Notification is only possible for medicines included in the regulations and provided that all the requirements established for the category in which they fall are met.

After approval and commercialization, pharmacovigilance activities are conducted to identify, assess, and monitor adverse events associated with the use of the medicine. The objective is to ensure that the benefit-risk balance remains favorable throughout the product’s lifecycle.

Regulatory Support Services

Freyr supports the Brazilian drug registration process by providing gap analysis, dossier review, compilation, and submission services, ensuring full compliance with ANVISA regulatory requirements.

Product Maintenance and Compliance:

Sr. No Application Validity
01 Validity for Sanitary Registration / Marketing of Authorization (MoA) Ten (10) years from the date of registration.
02 Renewal of Registration certificate The renewal application must be requested no earlier than twelve months and no later than six months prior to the expiration date of the registration.
03 Post Approval Changes (Variations) Any change of registered medicine should be sent to ANVISA with relevant documents, on a case-by-case basis.

Pharmacovigilance

At Freyr, we are committed to patient safety and regulatory management; therefore, pharmacovigilance constitutes an essential component of our service portfolio, aligned with the requirements of the applicable health regulations in Brazil.

In Brazil, VigiMed is the official system used for reporting suspected adverse events related to medicines and vaccines by healthcare professionals, patients, Marketing Authorization Holders, and clinical trial sponsors.

These pharmacovigilance activities are regulated by ANVISA under the coordination of GGMON (General Management of Monitoring of Products Subject to Health Surveillance).

These activities include, among others:

  • Receipt, management, and reporting of Individual Case Safety Reports (ICSRs).
  • Preparation and submission of Periodic Safety Update Reports and Periodic Benefit-Risk Evaluation Reports (PSUR/PBRER).
  • Literature monitoring.
  • Development of Risk Management Plans (RMPs).
  • Post-marketing surveillance studies.
  • Safety signal detection and management.
  • Additional pharmacovigilance activities, when applicable.

Pharmaceutical companies must have a pharmacovigilance unit constituted, and all pharmacovigilance activities must be overseen by a local person responsible for pharmacovigilance, duly appointed in accordance with ANVISA requirements.

Associated Services for Pharmaceutical Product Registration in Brazil – Freyr Expertise

  • Regulatory Affairs Consulting and Pharma Market Access.
  • End-to-end Pharmaceutical Drug Product Registration.
  • Authorized local agent Support.
  • Pharma GMP Compliance Support.
  • Dossier Gap Analysis as per ANVISA Regulatory Requirements.
  • Preparation of Gap Analysis Report and Remediation Plan.
  • Pharmaceutical Dossier Preparation and Submission to ANVISA.
  • Brazil Pharma Regulatory Services.
  • Query Support Management until Approval.
  • Pharmaceutical Regulatory Services.
  • Pharmaceutical Lifecycle Management Support.
  • Pharmaceutical Artwork Management.
  • Ad-hoc Brazil Regulatory Consultation

Technovigilance (Post-marketing surveillance)

Technovigilance plays a key role in the post-market oversight of medical devices, supporting the early detection of potential risks, enabling timely corrective actions, and ensuring the continued safety, performance, and regulatory compliance of devices marketed in Brazil.

In Brazil, technovigilance activities are regulated and overseen by the Brazilian Health Regulatory Agency (Anvisa).

These activities include, among others:

  • Collection, analysis, and reporting of complaints, incidents, and adverse events related to medical device;
  • Management and reporting of health alerts.
  • Preparation and notification of technovigilance reports through the Notivisa system.

The Marketing Authorization Holder (MAH) is the legal entity responsible for the medical device registered in its name in Brazil. As such, it is responsible for responding to the health authorities regarding any technical complaint, adverse event, serious public health threat, safety alert, field action, or any other occurrence representing a sanitary risk associated with its products.

Also, the MAHs must have a technovigilance unit constituted, and all technovigilance activities must be overseen by a local person responsible for technovigilance, duly appointed in accordance with ANVISA requirements.