Collegiate Board Resolution

COLLEGIATE BOARD RESOLUTION No. 983 OF 28 JULY 2025

Amends Collegiate Board Resolution – RDC No. 843 of 22 February 2024, which provides for the regularization of food and packaging under the jurisdiction of the Brazilian Health Surveillance System (SNVS, in Portuguese) intended for supply within Brazilian territory.

COLLEGIATE BOARD RESOLUTION No. 982 of 28 July 2025

Provides for the use of health risk management criteria and compliance

monitoring for companies for the initial granting or renewal of the Good Manufacturing Practices Certificate or the Good Distribution and/or Storage Practices Certificate.

COLLEGIATE BOARD RESOLUTION No. 978 OF 6 JUNE 2025

Provides for the opera􀆟on of Services that perform actvities related to Clinical Analysis Tests (CAT).

Amends Collegiate Board Resolution – RDC No. 471 of 23 February 2021, which establishes the criteria for prescribing, dispensing, monitoring, packaging, and labeling medicinal products based on substances classified as prescription antimicrobials, whether isolated or in combination, as listed in a specific Normative Instruction.

Amends Collegiate Board Resolution – RDC No. 658 of 30 March 2022, which establishes the General Guidelines for Good Manufacturing Practices for Medicinal Products.

Provides for the updating of Annex I (Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control) of SVS/MS Ordinance No. 344 of 12 May 1998.

Establishes the general requirements for carrying out Forced Degradation Studies on medicines containing synthetic and semi-synthetic active pharmaceutical ingredients and defines the parameters for the notification, identification, and qualification of degradation products in these same products.

Amends Collegiate Board Resolution – RDC No. 326 of 3 December 2019, which establishes the positive list of additives for use in the production of plastic materials and polymeric coatings in contact with food.

Amends Collegiate Board Resolution – RDC No. 56 of 16 November 2012, which establishes the positive list of monomers, other starting substances, and polymers authorized for the production of plastic packaging and equipment in contact with food.

Provides for the simplified procedure for applications for the marketing authorization, postmarketing authorization and renewal of marketing authorization of medicinal products and gives other provisions.

Provides for the guidelines and procedures to conduct clinical trials in Brazil with a view to subsequently granting marketing authorization to medicinal products.

Provides for the Good Cosmetovigilance Practices for companies holding regularization of cosmetic products with the Brazilian Health Regulatory Agency (Anvisa).

Provides for the notification, registration and postregistration changes of medicinal gases classified as medicines.

COLLEGIATE BOARD RESOLUTION – RDC NO. 855 OF 23 APRIL 2024

Prohibits the manufacture, importation, commercialization, distribution, storage, transportation, and advertising of electronic smoking devices (ESDs).

COLLEGIATE BOARD RESOLUTION – RDC NO. 850 OF 20 MARCH 2024

Alters Collegiate Board Resolution – RDC no. 497 of 20 May 2021, which provides for the administrative procedures to grant the Good Manufacturing Practices Certificate and the Good Distribution and/ or Storage Practices Certificate.

COLLEGIATE BOARD RESOLUTION – RDC No. 843 OF 22 FEBRUARY 2024

Provides for the regularization of food and packaging under the jurisdiction of the Brazilian Health Surveillance System (SNVS) intended for supply within Brazilian territory.

COLLEGIATE BOARD RESOLUTION – RDC No. 848 OF 6 MARCH 2024

Provides for the essential safety and performance requirements applicable to medical devices and in vitro diagnostic (IVD) medical devices.

Provides for the conditions and procedures for the marketing authorization of pre-pandemic influenza vaccines, updating to a pandemic strain, and authorization of use, commercialization, and monitoring of pandemic influenza vaccines.

COLLEGIATE BOARD RESOLUTION – RDC No. 843 OF 22 FEBRUARY 2024

Provides for the regularization of food and packaging under the jurisdiction of the Brazilian Health Surveillance System (SNVS) intended for supply within Brazilian territory.

Provides for risk classification, notification and marketing authorization regimens, and instructions for use of in vitro diagnostic medical devices, including its instruments.

Amends Collegiate Board Resolution – RDC no. 47 of 8 September 2009, which establishes rules for the preparation, harmonization, updating, publication, and availability of medicine package inserts for patients and health professionals.

Amends Collegiate Board Resolu􀆟on – RDC No. 205 of 28 December 2017.

COLLEGIATE BOARD RESOLUTION RDC NO. 753 OF 28 SEPTEMBER 2022

Provides for the marketing authorization for medicinal products for human use with synthetic and semi synthetic active ingredients, classified as new, innovative, generic and similar medicinal products .

COLLEGIATE BOARD RESOLUTION RDC NO. 750 OF 6 SEPTEMBER 2022

Establishes the temporary optimized analysis procedure, which uses the assessments carried out by an Equivalent Foreign Regulatory Authority for the verified analysis of applications for marketing authorization and post marketing authorization for medicinal products biological pro ducts, and their inputs, as well as the active pharmaceutical ingredient dossier adequacy letter (CADIFA , in Portuguese ), submitted to Anvisa after Law no. 13,411 of 28 December 2016 entered into force .

Provides for waiver from bioequivalence/rela􀆟ve bioavailability studies.

Provides for the criteria to conduct rela􀆟ve bioavailability/ bioequivalence (BA/BE) studies and pharmacokine􀆟c studies.

Provides for the general criteria for the admissibility of analysis carried out by an Equivalent Foreign Regulatory Authority in a health surveillance process at Anvisa, through an optimized analysis procedure.

Establishes criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices.

Provides for the criteria for Good Manufacturing Practices Certification and establishes the inspection program for international establishments that manufacture active pharmaceutical ingredients.

Provides for the minimum requirements to guarantee the quality of imported biological products.

Provides for the Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products.

COLLEGIATE BOARD RESOLUTION RDC NO . 658 OF 30 MARCH 2022

Provides for the General Guidelines on the Good Manufacturing Practices for Medicin al Product s

Provides for the Good Manufacturing Practices for Active Pharmaceutical Ingredients.

It provides for the minimum requirements regarding the obligation, on the part of companies that are holders of marketing authorization for medicinal products, of notification on the implementation of medicinal products recall action to the competent health authorities and consumers, in the event of sufficient evidence or proof of quality deviation representing risk, aggravation, or consequence to health, as well as in the event of cancellation of marketing authorization related to safety and efficacy.

Provides for the marketing authorization for tobacco products.

Provides for the display for sale and the commercialization of tobacco products.

Provides for the requirements of composition and labelling of foods containing cereals for classification and identification as whole and to highlight the presence of whole ingredients.

Provides for the maximum tolerated limits (MTL) of contaminants in foods, the general principles for their establishment, and the analysis methods for the purposes of conformity assessment.

Provides for the criteria for prescribing, dispensing, controlling, packaging, and labeling medications based on substances classified as prescription antimicrobials, whether alone or in combination, as listed in a specific Normative Instruction.

Provides for the Good Practices of Distribution, Storage, and Transportation of Medicinal Products.

Provides for the nutritional labeling of packaged foods.

Establishes the requirements and conditions for the conduction of stability studies for the purposes of marketing authorization and postmarketing authorization alterations of biological products and makes other provisions.

Provides for the criteria for Good Manufacturing Practices certification and institutes the inspection program for international manufacturers of active pharmaceutical ingredients.

Establishes the Active Pharmaceutical Ingredient Dossier (DIFA) and the Active Pharmaceutical Ingredient Dossier Adequacy Letter (CADIFA).

Defines the requirements for the use of industrial trans fats in foods.

Provides for the assessment of risk to human health of veterinary medicinal products and the methods of analysis for the purposes of conformity assessment.

Provides for the health requirements for dietary supplements.

Provides for the requirements to confirm the safety of and the health benefits from probiotics for use in foods.

Establishes a special procedure for the approval of clinical trials, good manufacturing practices certification, and marketing authorization for new medicinal products for treatment, diagnosis, or prevention of rare diseases.

Provides for the prioritization of requests for marketing authorization, post-marketing authorization, and previous approval for clinical research of medicinal products.

Establishes the requirements for mandatory declaration indicating the presence of lactose on food labels.

Provides for the procedures to transfer the marketing authorization for products subject to health surveillance, global transfer of responsibility for clinical trials, and update of registration data related to the operation and certification of companies, as a result of corporate or commercial operations.

Provides for post-marketing authorization alterations, cancellation of marketing authorization for medicinal products with synthetic and semisynthetic active ingredients, and gives other provisions.

Establishes parameters for reporting, identification and qualification of degradation products in medications with synthetic and semi-synthetic active substances, classified as new, generic and similar, among other provisions.

Provides on the requirements for mandatory labelling of the main foods that cause food allergies.

Provides for the Good Manufacturing Practices for Active Pharmaceutical Ingredients.

Approves the Technical Regulation for the Good Manufacturing Practices for Medical Devices and In Vitro Diagnostic Devices and gives other provisions.

Provides on the conduction of stability studies on active pharmaceutical ingredients.

Provides for the maximum limits of tar, nicotine, and carbon monoxide in cigareties, as well as restrictions on the use of additives in tobacco products and gives other provisions.

Provides for the conduction of Pharmaceutical Equivalence and Comparative Dissolution Profile Studies.

Provides for advertising, publicity, information, and other practices, the objective of which is the dissemination or commercial promotion of medicinal products.

Approves the Technical Regulation for Generic Medicinal Products.