Collegiate Board Resolution
2025
Collegiate Board Resolution | Subject |
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. | |
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. | |
Provides for the operaon 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. | |
COLLEGIATE BOARD RESOLUTION – RDC ANVISA No. 963 OF 20 FEBRUARY 2025 | 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. |
COLLEGIATE BOARD RESOLUTION – RDC No. 961 OF 6 FEBRUARY 2025 | 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. |
2024
Collegiate Board Resolution | Subject |
COLLEGIATE BOARD RESOLUTION – RDC No. 954 OF 20 DECEMBER 2024 | 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. |
COLLEGIATE BOARD RESOLUTION – RDC No. 945 OF 29 NOVEMBER 2024 | 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. | |
Prohibits the manufacture, importation, commercialization, distribution, storage, transportation, and advertising of electronic smoking devices (ESDs). | |
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. |
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. |
2023
Collegiate Board Resolution | Subject |
COLLEGIATE BOARD RESOLUTION – RDC NO. 830 OF 6 DECEMBER 2023 | Provides for risk classification, notification and marketing authorization regimens, and instructions for use of in vitro diagnostic medical devices, including its instruments. |
2022
Collegiate Board Resolution | Subject |
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. | |
COLLEGIATE BOARD RESOLUTION – RDC No. 763 OF 25 NOVEMBER 2022 | Amends Collegiate Board Resoluon – 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. 751 OF 15 SEPTEMBER 2022 | Provides for risk classification, notification and marketing authorization systems, as well as labeling requirements and use instructions regarding medical devices. |
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 . | |
COLLEGIATE BOARD RESOLUTION – RDC No. 749 OF 5 SEPTEMBER 2022 | Provides for waiver from bioequivalence/relave bioavailability studies. |
Provides for the criteria to conduct relave bioavailability/ bioequivalence (BA/BE) studies and pharmacokinec 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. | |
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. |
2021
Collegiate Board Resolution | Subject |
Provides for the marketing authorization for tobacco products. | |
Provides for the display for sale and the commercialization of tobacco products. | |
Provides for the rules to conduct clinical trials with investigational Advanced Therapy Medicinal Products in Brazil and gives other provisions. | |
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 health requirements for vegetal oils and fats | |
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. |
2020
Collegiate Board Resolution | Subject |
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. | |
Amends Collegiate Board Resolution – RDC No. 200 of 26 December 2017 and Collegiate Board Resolution – RDC No. 73 of 7 April 2016, to provide for the submission of the Active Pharmaceutical Ingredient Dossier (DIFA) in medicinal product marketing authorization and post-marketing authorization, respectively. | |
Establishes the Active Pharmaceutical Ingredient Dossier (DIFA) and the Active Pharmaceutical Ingredient Dossier Adequacy Letter (CADIFA). |
2019
Collegiate Board Resolution | Subject |
COLLEGIATE BOARD RESOLUTION – RDC NO. 332 OF 23 DECEMBER 2019 | 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. | |
COLLEGIATE BOARD RESOLUTION - RDC NO. 318 OF 6 NOVEMBER 2019 | Establishes the criteria for the conduction of Stability Studies for active pharmaceutical ingredients and medicinal products, except biologicals, and gives other provisions. |
COLLEGIATE BOARD RESOLUTION – RDC No. 249 OF 13 SEPTEMBER 2005 | Determines that all establishments manufacturers of intermediate products and active pharmaceutical ingredients must comply with the directives established in the TECHNICAL REGULATION OF GOOD MANUFACTURING PRACTICES OF INTERMEDIATE PRODUCTS AND ACTIVE PHARMACEUTICAL INGREDIENTS, in accordance with Annex I of this Resolution. |
2018
Collegiate Board Resolution | Subject |
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. | |
Provides for the organization of health surveillance actions carried out by the Union, States, the Federal District, and Municipalities, regarding Operation Authorization, Licensing, Marketing Authorization, Certification of Good Practices, Monitoring, Inspection, and Standardization, within the scope of the Brazilian Health Surveillance System (SNVS, in Portuguese). |
2017
Collegiate Board Resolution | Subject |
COLLEGIATE BOARD RESOLUTION – RDC No. 205 OF 28 DECEMBER 2017 | 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. |
COLLEGIATE BOARD RESOLUTION – RDC No. 204 OF 27 DECEMBER 2017 | Provides for the prioritization of requests for marketing authorization, post-marketing authorization, and previous approval for clinical research of medicinal products. |
COLLEGIATE BOARD RESOLUTION – RDC NO. 200 of 26 DECEMBER 2017 | Provides for the criteria for the granting and renewal of the marketing authorization of medicinal products with synthetic and semisynthetic active ingredients, classified as new, generic, and similar medicinal products, and gives other provisions. |
Provides for the validation of analytical methods and gives other provisions. | |
COLLEGIATE BOARD RESOLUTION – RDC NO. 136 OF 8 FEBRUARY 2017 | Establishes the requirements for mandatory declaration indicating the presence of lactose on food labels. |
2016
Collegiate Board Resolution | Subject |
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. |
2015
Collegiate Board Resolution | Subject |
COLLEGIATE BOARD RESOLUTION – RDC No. 53 OF 4 DECEMBER 2015(*) | 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. |
2014
Collegiate Board Resolution | Subject |
Provides for the Good Manufacturing Practices for Active Pharmaceutical Ingredients. |
2013
Collegiate Board Resolution | Subject |
Approves the Technical Regulation for the Good Manufacturing Practices for Medical Devices and In Vitro Diagnostic Devices and gives other provisions. |
2012
Collegiate Board Resolution | Subject |
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. |
2010
Collegiate Board Resolution | Subject |
Provides for the conduction of Pharmaceutical Equivalence and Comparative Dissolution Profile Studies. |
2008
Collegiate Board Resolution | Subject |
COLLEGIATE BOARD RESOLUTION – RDC NO. 96 OF 17 DECEMBER 2008 | Provides for advertising, publicity, information, and other practices, the objective of which is the dissemination or commercial promotion of medicinal products. |
2003
Collegiate Board Resolution | Subject |
Approves the Technical Regulation for Generic Medicinal Products. |