Law No. 9.782 establishing the National System of Sanitary Surveillance, and creating the National Sanitary Surveillance Agency.
Country
Type of law
Legislation
Date of original text
Date of latest amendment
Abstract
This Law, consisting of 46 articles divided into six Chapters and one Annex, establishes the National System of Sanitary Surveillance, and creates the National Sanitary Surveillance Agency (ANVISA). The National System comprises actions defined by Law No. 8.080 of 19 September 1990, implemented by the Federal Government's direct and indirect Public Administration, States, Federal District and Municipalities, that carry out activities of regulation, standardization, control and inspection in the area surveillance. ANVISA is the responsible authority to implement and enforce the provisions of items II to VII of art. 2 by performing the following activities: coordinate the National Health Surveillance System; promote and carry out studies and research within the scope of its attributions; establish norms, propose, follow up and execute the policies, the directives and the actions of sanitary surveillance; establish norms and standards on limits of contaminants, toxic wastes, disinfectants, heavy metals and others. Goods and products that are subject to sanitary control and inspection by the Agency are: medicines for human use, their active substances and other inputs, processes and technologies; food, including beverages, bottled waters, their inputs, packaging, food additives, limits on organic contaminants, residues of agrochemicals and veterinary drugs; any products involving the possibility of health risk, etc.
The Law is divided as follows: Creation and Competence of the National Health Surveillance Agency; Organizational Structure; Management Agreement; Equity and Revenues; Final and Transitional Provisions. The Annex specifies Sanitary Surveillance Inspection Fees.
The Law is divided as follows: Creation and Competence of the National Health Surveillance Agency; Organizational Structure; Management Agreement; Equity and Revenues; Final and Transitional Provisions. The Annex specifies Sanitary Surveillance Inspection Fees.
Attached files
Web site
Entry into force notes
This Law enters into force on the day of its publication.
Notes
Last amendments up to Law No. 13.411 of 28 December 2016.
Repealed
No
Source language
English
Legislation Amendment
No
Original title
Lei n. 9.782 - Define o Sistema Nacional de Vigilância Sanitária, cria a Agência Nacional de Vigilância Sanitária, e dá outras providências.