Normative Instruction

NORMATIVE INSTRUCTION No. 394 OF 15 AUGUST 2025

Provides for general requirements, analytical tolerances, label flow, list of categories, and proof of expiration date for sanitizing products, in accordance with Collegiate Board Resolution No. 989 of 15 August 2025.

It defines the list of isolated or combined substances used in prescription and prescription-retaining medicinal products, as provided for in Collegiate Board Resolution – RDC No. 471 of 23 February 2021.

NORMATIVE INSTRUCTION – IN NO. 338 OF 29 NOVEMBER 2024

Establishes, in accordance with Anvisa Collegiate Board Resolution RDC no. 945 of 29 November 2024, the list of Equivalent Foreign Regulatory Authorities (EFRAs) and details the criteria to adopt the optimized analysis procedure through regulatory reliance, as well as through risk and complexity assessment of applications for DDCM, DEEC, substantial alterations in the investigational product, and substantial amendments to the clinical protocol.

Establishes the list of medicinal gases classified as medicines subject to notification.

Provides for the specific criteria and procedures to define the Equivalent Foreign Regulatory Authorities for the process of health inspection of manufacturers of active pharmaceutical ingredients, Cannabis products for medicinal purposes, medicinal products, and biological products, as well as the optimized analysis procedure for the purposes of Good Manufacturing Practices Certification.

Establishes, in the terms of Collegiate Board Resolution – RDC no. 741 of 10 August 2022, optimized procedures for the purposes of analysis and decisionmaking regarding petitions for marketing authorization for medical devices, by taking advantage of analyses carried out by an Equivalent Foreign Regulatory Authority (EFRA).

It establishes the way to regularize the different categories of food and packaging, and the respec􀆟ve documenta􀆟on that must be presented.

Establishes the list of active pharmaceutical ingredients with phonetic or graphic similarity with other ingredients.

Establishes specific requirements for the labelling of large volume parenteral solutions, solutions for irrigation, dialysis, plasma expanders, and small-volume parenteral solutions.

Establishes the list of oral medicines intended for local ac􀆟on in the gastrointes􀆟nal tract that are candidates for biowaiver, as provided for in Ar􀆟cle 7, Item VI, of Collegiate Board Resolu􀆟on – RDC No. 749 of 5 September 2022.

Provides for permeability tests with Caco-2 cells and the valida􀆟on of such assays.

Provides for the Good Manufacturing Practices complementary to the reference and retention samples.

Provides for the Good Manufacturing Practices complementary to computerized systems used in the manufacture of medicinal products.

Establishes the maximum tolerated limits (MTLs) of contaminants in foods.

Establishes the list of authorized vegetal species, designations, composition of fatty acids, the maximum acidity values, and the maximum peroxide index values for vegetal oils and fats. 

Establishes the technical requirements for declaring the nutrition labeling of packaged foods.

Provides for the inclusion of new formula declaration on the label of foods when their composition is altered. 

Establishes the list of maximum residue limits (MRL), acceptable daily intake (ADI), and acute reference dose (ARfD) for active pharmaceutical ingredients (API) of veterinary medicinal products in foods of animal origin.