ANVISA Resolution 982/2025 - English Translation

THE BOARD OF DIRECTORS OF THE NATIONAL HEALTH SURVEILLANCE AGENCY, using the powers conferred by article 15, III and IV, combined with article 7, III and IV of Law No. 9,782, of January 26, 1999, and article 187, VI, § 1 of the Internal Regulations approved by Resolution of the Board of Directors - RDC No. 585, of December 10, 2021, resolves to adopt the following Resolution, as deliberated in a meeting held on July 28, 2025, and I, Acting Director-President, determine its publication.

Art. 1 This Resolution provides for the use of health risk management criteria and monitoring of company compliance for purposes of initial granting or renewal of the Good Manufacturing Practices Certificate (CBPF) and the Good Distribution and/or Storage Practices Certificate (CBPDA) for establishments that carry out manufacturing, distribution and storage activities of active pharmaceutical ingredients (APIs), medicines, Cannabis products for medicinal purposes, biological products and medical devices.

Art. 2 For the purposes of this Resolution, the following definitions are adopted:

I - storage: set of operations that includes guarding, handling and safe conservation of products and related controls;

II - Equivalent Foreign Regulatory Authority (AREE): foreign regulatory authority or international entity that has regulatory practices aligned with those of Anvisa, responsible for ensuring that products authorized for distribution have been adequately evaluated and meet recognized standards of quality, safety and efficacy, and which will be considered by Anvisa in regulatory confidence practice;

III - Good Distribution and/or Storage Practices Certificate (CBPDA): document issued by Anvisa certifying that a certain establishment complies with the technical requirements of Good Distribution and Storage Practices or Good Storage Practices, set forth in current legislation, necessary for product commercialization;

IV - Good Manufacturing Practices Certificate (CBPF): document issued by Anvisa certifying that a certain establishment complies with the technical requirements of Good Manufacturing Practices, set forth in current legislation, necessary for product commercialization;

V - distribution: set of activities related to cargo movement that includes supply, storage and dispatch of products, excluding direct supply to the public;

VI - establishment: unit responsible for performing one or more activities that can be certified;

VII - manufacturing: all operations involved in the preparation of a given product, including acquisition of materials, production, quality control, release, storage, dispatch of products and related controls;

VIII - pharmaceutical form: final state of presentation of a pharmaceutical preparation after one or more operations performed, with or without the addition of excipients, in order to facilitate its use in a given route of administration;

IX - risk management: systematic process consisting of several stages for identification, evaluation, control, monitoring and communication of associated risks, with the objective of ensuring safety, quality and efficacy throughout the entire life cycle of products subject to health surveillance;

X - health inspection: set of technical and administrative procedures that aims to protect individual and collective health, through on-site verification or, in specific cases, remotely, of compliance with legal and regulatory health frameworks related to developed activities and health conditions of establishments, processes and products, allowing the adoption of guidance and correction measures for situations that may cause harm to population health;

XI - active pharmaceutical ingredient: any substance introduced in the formulation of a pharmaceutical form that, when administered to a patient, acts as an active ingredient, and that may exercise pharmacological activity or other direct effect in diagnosis, cure, treatment or prevention of a disease, and may also affect the structure and functioning of the human organism;

XII - biological active pharmaceutical ingredient: active pharmaceutical ingredient obtained from starting materials of biological origin;

XIII - Medical Device Single Audit Program (MDSAP): international program that allows health product manufacturers to be audited by recognized certification organization;

XIV - inspection report: report that describes the company's situation regarding compliance with good manufacturing and/or distribution and storage practices, according to the standards referenced in the report scope;

XV - inspection report from Equivalent Foreign Regulatory Authority (AREE): report issued by foreign regulatory authority or international entity that has regulatory practices aligned with those of Anvisa considered in regulatory confidence practice, whose content describes the company's situation regarding compliance with good manufacturing practices according to the standards referenced in the report; and

XVI - equivalent inspection report: report issued by health authority or auditing body recognized by Anvisa that describes the company's situation regarding compliance with good manufacturing and/or distribution and storage practices, according to the standards referenced in the report scope.

Art. 3 The criteria for health risk management applied to granting or renewal of CBPF or CBPD/A for establishments that carry out activities related to active pharmaceutical ingredients (APIs), medicines, Cannabis products for medicinal purposes, biological products and medical devices are:

I - product class and risk classification;

II - complexity and criticality of the establishment;

III - storage and transport conditions of input(s) and finished product(s);

IV - compliance history and regularity of companies and products;

V - history of compliance with Good Manufacturing Practices and Distribution and/or Storage by the establishment to be certified;

VI - line, manufacturing stage and pharmaceutical form to be certified;

VII - post-market monitoring of products;

VIII - time elapsed since last inspection;

IX - inspection reports or CBPF issued by Equivalent Foreign Regulatory Authority (AREE);

X - inspection reports or CBPF issued by regulatory authorities or member entities of the Pharmaceutical Inspection Cooperation Scheme (PIC/s);

XI - inspection report issued by health authority of member country of the International Medical Device Regulators Forum (IMDRF);

XII - audit reports issued under the Medical Device Single Audit Program (MDSAP);

XIII - results of laboratory, fiscal or control analyses;

XIV - national and international epidemiological and health context;

XV - control by random inspection;

XVI - risk of discontinuation of products subject to health surveillance in the national market; and

XVII - inspection report issued by Anvisa or by State, District or Municipal Health Surveillance agencies, according to organization of health surveillance actions and competencies exercised by the Union, States, Federal District and Municipalities.

§ 1 The criteria listed in items I to XVII of this article are not arranged in order of application or relevance and will be used in combination, observing the health risk involved and the applicability of the criterion to the manufacturing unit subject to certification.

§ 2 The analysis of risk management criteria will be performed by Anvisa based on information provided by the applicant, together with information available in Anvisa systems and external databases.

§ 3 Results based on Artificial Intelligence models may be used as risk management criteria, provided they meet Anvisa's technical standards of consistency, data protection, traceability and technical validation.

Art. 4 Initial granting or renewal of CBPF or CBPDA referred to in article 1 of this Resolution must occur through:

I - analysis of inspection report from Equivalent Foreign Regulatory Authority (AREE);

II - risk analysis, according to criteria established in article 3 of this Resolution; and

III - conducting inspection, motivated by risk analysis result.

§1 Adoption of one or more of the mechanisms listed in items I to III of this article does not exempt the preparation of technical opinion.

§2 The mechanisms listed in items I to III of the caput of this article may be used in combination, observing the principles of Public Administration.

Art. 5 Health requirements and technical-administrative guidelines are maintained for all initial granting or renewal processes of CBPF and CBPDA referred to in article 1 of this Resolution, regardless of adoption of mechanisms referred to in article 4 of this Resolution.

Art. 6 Initial granting or renewal processes of CBPF and CPBDA referred to in article 1 of this Resolution will be subjected to continuous compliance monitoring, based on criteria established in article 3 of this Resolution.

§1 Information obtained through monitoring referred to in the caput may indicate the need to conduct inspection, regardless of CBPF or CBPDA validity.

§2 Based on monitoring data referred to in the caput of this article, Anvisa may, at any time, determine the initiation of investigation proceedings or Certificate cancellation.

§3 Cancellation referred to in § 2 of this article must be supported by justifications related to identification of irregularities or risks related to the establishment or products supplied by it.

Art. 7 Anvisa's action to verify compliance with Good Manufacturing or Distribution and Storage Practices may be complemented by specific inspection programs.

Sole paragraph. Programs referred to in the caput of this article will be defined based on health risk management provided for in article 3 of this Resolution, considering the complexity of related activities, technologies involved, historical inspection, monitoring and product registration data.

Art. 8 The applicability of requirements of this Resolution to initial granting or renewal processes of CBPF or CPBDA, for which no decision has been published in the Official Gazette of the Union, is established.

Sole paragraph. Petitions filed with Anvisa prior to this Resolution entering into force are included in the provisions of the caput of this article.

Art. 9 Application of health risk management mechanisms established in article 4 of this Resolution to initial granting or renewal processes of CBPF or CBPDA referred to in article 1 of this Resolution is conditioned to approval by the Board of Directors.

Art. 10 Resolution - RDC No. 497, of May 20, 2021, published in Official Gazette of the Union No. 98, of May 26, 2021, section 1, pages 205-207, shall be in force with the following changes:

"Art. 4 Granting of Certification referred to in this Resolution is conditioned to analysis through risk management and issuance of technical opinion certifying that the establishment meets the technical requirements of Good Manufacturing Practices or Good Distribution and/or Storage Practices necessary for product commercialization. ........................................................................................................................" (NR)

"Art. 10. Good Manufacturing Practices Certification and Good Distribution and/or Storage Practices Certification must be cancelled at any time, whenever there is analysis through risk management and technical opinion certifying that the establishment does not meet the technical requirements of Good Manufacturing Practices or Good Distribution and/or Storage Practices necessary for product commercialization. ......................................................................................................................." (NR)

"Art. 35. For decision regarding Good Practices Certification referred to in this chapter, in case of establishments located in MERCOSUR countries, except Brazil, Anvisa is responsible for analysis through risk management and issuance of technical opinion, based on guidelines set forth by existing legislation within MERCOSUR scope." (NR)

"Art. 36. In case of establishments located in national territory or in other countries outside MERCOSUR, Certification referred to in this chapter must be granted through analysis by risk management and issuance of technical opinion, which must consider the following items: ................................................................................................................................. Sole paragraph. The opinion set forth in the caput of this article may consider other factors defined through risk management." (NR)

OFFICIAL GAZETTE OF THE UNION