1. ANVISA
National Health Surveillance
Agency
.

2. INTRODUCTION
 ANVISA is regulatory body of BRAZIL. Brazil is biggest
country of South America. Some of the small countries
nearby Brazil are following the rules according to ANVISA.
 ANVISA means “Agencia Nacional de Vigilancia
Sanitaria”. This abbreviation is in Portuguese language. In
English, it means “National Health Surveillance Agency”
or sometimes it is written as “Brazilian Health
Surveillance Agency”.
 ANVISA is established on 26th January, 1999. Thus it
does not have long historical backgrounds.
 To get information about ANVISA, one has to open the
website www.anvisa.gov.br. The website will open in
Portuguese language first.

5. ANVISA
 ANVISA's Mission
"To protect and promote health, ensuring
the hygiene and safety of products and
services and taking part in developing
access to it."
 Values
Transparency
Knowledge
Cooperation

6. HIGHLIGHTS OF ANVISA
National System of Sanitary Surveillance
 In this section, you will find the addresses (in
portuguese) of the federal, state and municipal
units of sanitary surveillance that make up the
National System of Sanitary Surveillance.

7. HIGHLIGHTS OF ANVISA
Generic Drugs
 FAQs – Frequently Asked Questions. Answers given
for most frequently asked question about Generic
drugs by citizen.
 Industry –
 In this section, industry professionals can obtain information
about Brazil's Generic Drugs Policy.
 If your company wishes to apply for registration of a generic
drug, whose reference drug has not yet been informed by
ANVISA, please make a formal request to the Office of
Generic Drugs.
 Pharmaceutical equivalence and bioequivalence tests needed
for registering generic drugs can only be carried out by
reference centers duly authorized by ANVISA.
 Legislation – Rules and documents related to
regulation and registration of drugs in Brazil. Various
Guidelines different categories are given.

8. HIGHLIGHTS OF ANVISA
Medicine Bioavailability Bioequivalence
Centers
 Application Forms for BA/BE centers
Certification for Medicine Bioavailability/Bioequivalence Centers
Renewal of Certification for Medicine Bioavailability/Bioequivalence
Centers
 Centersfor carrying out BA/BE shall observe the
rules and technical regulations in force
 BA/BEGood Practices Manual is given in two
volumes

9. HIGHLIGHTS OF ANVISA
Travelers Information
How to get an International Certificate of Vaccination against
yellow fever
 In order to leave Brazil or travel to some of its areas, for example,
vaccination against yellow fever is needed at least 10 days before
travelling and you should bring with you your International Certificate
of Vaccination (ICV).
 With one shot, you will be protected for 10 years.
 People who were vaccinated more than 10 years ago need only a booster,
after which immunity comes immediately.
 Anvisa's Public Health Care Centers and Vaccination Rooms (in
Portuguese) are ready to provide the vaccine and to issue the
International Certificate of Vaccination (ICV), which is yellow.
 Every person vaccinated in one of the Sanitary Units of the Unified
Health System (SUS) receives the National Certificate of Vaccination,
which is white and accepted in the whole country.
 If, after that, you need the ICV, you should go to a Public Health Care
Center or to a Vaccination Room of ANVISA to copy the National
Certificate data to the International one. The signature of the Certificate
owner in the presence of the official agent who copies the data is
mandatory.

10. HIGHLIGHTS OF ANVISA
Severe Acute Respiratory Syndrome
 In Brazil, there may be probability of getting
Severe Acute Respiratory Syndrome (SARS)
disease, similar to yellow fever. Thus, ANVISA
had provided information on website for it. They
had provided WHO website link for direct
information.

11. OFFICES OF ANVISA
 Advisory Council
 Office of Ombudsman

12. OFFICES OF ANVISA
Advisory Council
 The Advisory Council is a collegiate body comprises
representatives of public administration
institutions, organized civil society and the scientific
community.
 Its main functions are
- To monitor and follow up the development of
activities carried out by the National Health
Surveillance Agency
- Requesting information and formulating proposals
relevant to the activities of the Agency.
 The Council convenes every three months.

13. OFFICES OF ANVISA
Office of Ombudsman
 The Office of the Ombudsman is a communication channel through
which the population speaks up and the Institution responds, informs
and educates.
 The Ombudsman is nominated by the Minister of the Health and
appointed by the President of the Republic for a two-year term.
 The Ombudsman is not allowed to hold any direct or indirect interest
in any company or any persons subject to the areas of action of the
Brazilian Sanitary Surveillance Agency.
 The Ombudsman enjoys full independence of action.
The Ombudsman is responsible for:
1. Receiving complaints from citizens and institutions and, within a
maximum deadline of two working days, to direct these through the
appropriate channels and to provide the person making the
denunciation or complaint with a response, informing, if appropriate,
of the steps to be taken henceforth;
2. Providing responses to the demands within the agreed deadlines
3. Producing monthly reports to the Collegiate Board of Directors
containing information about the steps taken and the manner in

14. GENERAL INFORMATION
SECTIONS
The institution
 Overview
 Competencies
 Structure
 Background
 Contact us

15. GENERAL INFORMATION
SECTIONS
ANVISA Informs
 Articles and interviews
 News
 Public consultation

16. GENERAL INFORMATION
SECTIONS
Services
(user services, database, revenues)

17. GENERAL INFORMATION
SECTIONS
Areas of action
 Blood and blood products
 Cosmetics
 Drugs
 Generic drugs
 Food
 Heath services
 International affairs
 Market regulation
 Medical devices
 Pharmacovigilance
 Ports, airports and borders
 Reblas- Brazilian Laboratory Network
 Sanitization products
 Tobaco
 Toxicology

18. GENERAL INFORMATION
SECTIONS
Legislation
 Cosmetics
 Drugs
 Food
 Generic Drugs
 Imported Merchandise
 Medical Devices
 Pharmacovigilance
 Ports, Airports and Borders
 Tobacco Products
 Technical Regulation - Rules for Inspections
applicable to inspect drug manufacturing
establishments

19. THE INSTITUTION
Overviews:
 The National Health Surveillance Agency was established by
January 26, 1999.
 The Agency is designated an autonomous agency operating under
a special regime. This means that ANVISA is an independently
administered, financially-autonomous regulatory agency.
 The Agency is managed by a Collegiate Board of Directors,
comprised of five members.
 The institutional purpose of the agency is to foster protection of
the health of the population by exercising sanitary control over
production and marketing of products and services subject to
sanitary surveillance.

20. THE INSTITUTION
Competencies:
 To coordinate the National System of Health Surveillance;
 To foster and carry out studies and research in line with the
Agency's range of agreed functions;
 To establish norms and standards regarding restrictions on
contaminants, toxic waste, disinfectants, heavy metals and other
materials which constitute a health risk;
 To administer and collect the Health Surveillance Inspection Fee
 To authorize the operation of manufacturing, distribution and
importing firms concerned
 To give assent to the importation and exportation of the products
listed in the Statute of the National Health Surveillance Agency
 To grant product registration permits in accordance with the
norms ascribed to the Agency's area of activity;
 To grant and to withdraw certificates of good manufacturing
practice
Continued……..

21. THE INSTITUTION
 To proscribe, as a health surveillance measure, manufacturing plants and those
premises involved in the management, importation, storage, distribution and sale
of health related products and services in the event of violation of the relevant
legislation, or on account of their constituting a likely health risk ;
 To prohibit the manufacture, importation, warehousing, distribution and
marketing of products and inputs in the event of any violation of the relevant
legislation or because such products and services constitute a likely health risk ;
 To cancel the operating permits, including special permits, of companies in the
event of violation of the relevant legislation or because of an impending health
risk ;
 To set up, coordinate and monitor toxicological and pharmaceutical surveillance
systems;
 To take the lead in revising, and periodically bringing up to date, the
pharmacopeia;
 To monitor and audit state, district and municipal bodies comprising the National
System of Health Surveillance, including the official health quality control
laboratories;
 To coordinate and carry out quality control in respect of goods
 To foster and develop staff resources for the National System of Health
Surveillance and to carry out domestic and international technical cooperation
activities;
 To summon offenders and apply the penalties foreshadowed in law;

22. THE INSTITUTION
 To monitor the prices of medical drugs,
items of equipment, components, inputs
and health services;
 Epidemiological surveillance and vector
inspection activities in respect of ports,
airports and border crossing points
 The Agency shall carry out its activities
fully in accordance with the guidelines.
 Regulating, controlling and inspecting
products and services which involve risks
to public health are within the proper
remit of the Agency.

23. THE INSTITUTION
Background of sanitary surveillance in Brazil
 Sanitary surveillance activities began in the 18th and 19th
Centuries with the aim of avoiding the spread of disease in the
world's newly emerging urban centers.
 The main purpose of this exclusive State responsibility was to
keep watch over certain professional activities, to put a stop to
charlatanism, and to inspect ships, cemeteries and places where
food was on sale to the public.
 The result was that the State, with the full power of the
Constitution behind it, became the repository of a wide range of
sanitary surveillance responsibilities, looking after the rights of
the consumer and assuming responsibility for providing better
health conditions for the population.

24. THE INSTITUTION
Structure of the National Health Surveillance
Agency Board of Directors
 Collegiate
 Advisory Center for Strategic Management
 Social and Institutional Communication Advisory Nucleus
 Center for Surveillance of Adverse Events and Quality Deviations
 Office of the Attorney
 Internal Affairs Office
 Office of the Ombudsman
 Advisory Council
 Committee for Management of Sanitary Surveillance Information System
 Committee for Policy on Human Resources for Sanitary Surveillance
 Sector Committee for Processes and Debureaucratization
 Committee for Decentralization of Sanitary Surveillance Actions
 Audit Office
 Advisory Office for Decentralization of Sanitary Surveillance Actions

25. THE INSTITUTION
 Advisory Office for Institutional Relations
 General Office of Administrative and Financial Management
 General Office of Blood, other Tissues, Cells and Organs
 General Office of Cosmetics
 General Office of Drugs
 General Office of Economic Regulation and Market Monitoring
 General Office of Foods
 General Office of Health Services Technology
 General Office of Inspection and Control of Inputs, Drugs and Products
 General Office of International Relations
 General Office of Knowledge and Documentation Management
 General Office of Laboratories of Public Health
 General Office of Medical Devices Technology
 General Office of Ports, Airports and Borders
 General Office of Sanitizing Products
 General Office of Toxicology

26. ANVISA INFORMS
This section includes various recent articles,
interviews and reports related to
 Products
 New developments in regulations
 Ombudsman activity
 New standards for calibration or testing
procedures
 Health and market survelliance

27. USER SERVICES
Gives e-mail address to request
information on
 Petitions
 required documents
 registration application processes
 import of products
 company operation authorization
 payment of sanitary surveillance
inspection fees

28. USER SERVICES
Database
In this section you can consult the database of
the various areas of the Agency, to obtain
information about registered products, companies
with operation permits, processes, among others.
(Portuguese)

29. USER SERVICES
Revenues
 The Brazilian Sanitary Surveillance Agency
provides a fee collection
service (in Portuguese), for on-line access to a
printable Fee Collection

30. AREAS OF ACTION
1. Blood and Blood Products
1.1 National Blood and Blood Products Policy
1.2 Campaign for blood donations
2. Cosmetics
2.1 Legislation
2.2 Technical Background
2.3 Product Notification
2.4 Registration of Product
3. Drugs
3.1 Controlled Medicines
3.2 Registration of Medicines
4. Generic Drugs
4.1 Frequently asked questions
4.2 Industry
4.3 Legislation

31. AREAS OF ACTION
5. Food
5.1 Legislation
5.2 Inspection
5.3 Registration of Products
5.4 Program for calculation of Compulsory Nutritional Information on Food
and Drink Labels
6. Health Services
6.1 Health Care Architecture and Design
6.2 Infection Control in Health Services
7. International Affairs
7.1 Overview
7.2 International Agreements (Multilateral, Regional and Bilateral)
7.3 National legislation X International References
8. Market Regulation

32. AREAS OF ACTION
10. Pharmacovigilance
10.1 Background
10.2 International drug monitoring program – WHO
10.3 Who are we?
10.4 Structure and Relationship
10.5 What we did from 2002 – 2003
10.6 Business plan for 2002/2003
10.7 Business plan for 2001
10.8 Marketing review
10.9 International recall monitoring
10.10 Regulatory acts
10.11 Publications
10.12 Pharmacovigilance unit wins international award
10.13 Adverse drug reaction form
10.14 Contact us
10.15 Banner – Technical complaints form

33. AREAS OF ACTION
11. Ports, Air ports and Borders
11.1 Overviw
11.2 Airports
11.3 Sanitary inspection products
11.4 Borders
11.5 Ports
11.6 Brazil – Ballast water
11.7 Banners
12. Reblas – Brazilian Laboratory network
12.1 Overview
12.2 Contact us
13. Snaitizing products
14. Tobaco

34. AREAS OF ACTION
15.Toxicology
15.1 Overview
15.2 Objuctives
15.3 Registration procedure concerning pesticides
15.4 Tests and information required for pesticides toxicological
evaluation
15.5 Reference methodologies
15.6 Post registration procedure concerning pesticides products
15.7 Pestiside Residues in foods
15.8 Product quality
15.9 Pestiside poisoning

35. LEGISLATION
Cosmetics
 Definition and Classification of Personal
Hygiene Products, Cosmetics and Perfumes
and other products

36. LEGISLATION
Drugs
 Registration of industrialized Homeopathic drug products, the
exemption of registration of industrialized homeopathic drug products,
their dispensation and their classification in the sales category of
homeopathic drug products.
 All drug products that have their Therapeutic groups and
indications described in the Annex, shall be sold over the counter,
except for those administered parenterally, that shall be sold with
prescription only.
 Technical Regulation for the registration of Similar Drugs. Whereas
the information contained in the Package inserts and Packaging of
drug products is extremely important for professional prescribers’ and
users giving details of the active ingredients and usage warnings.
 Technical Regulation for New Drugs with Synthetic or Semi-
Synthetic Active Ingredients
 Technical Regulation for Generic Drugs.
 First registration renewal after the publication of this resolution,
all holders of drug product registrations shall submit production and
quality control reports as described in specific legislation.
 GUIDE FOR RELATIVE
BIOAVAILABILITY/BIOEQUIVALENCE TESTS".

37. LEGISLATION
Food
 Obligatory nutritional labeling of packaged foods and
beverages
 Packaged food and beverage serving size
 Manual of basic procedures for registration and exemption
from obligatory registration of food products
 Basic procedures to be followed for the registration of imported
products in the area of foodstuffs and the exemption of the
same from the compulsory requirement
 Technical regulation on procedures for registration of foods
with functional and or health claims on their labels.
 Technical regulation establishing the basic guidelines for
analysis and proof of functional and or health claims on food
labels
 Technical regulation establishing the basic guidelines for
evaluation of risk and safety of foods
 Technical regulation on procedures for registration of foods
and or new ingredients

38. LEGISLATION
Generic drugs
 Use of generic names in pharmaceutical products,
 Special measures in relation to the registration of generic medicine,
 Special measures to provide the filing of generic medicines,
 The importation of pharmaceutical products subject to the Sanitary
Surveillance Regimen shall only be made by companies which are legally
authorized to function as importers by the Sanitary Surveillance Secretary /
Ministry of Health.
 Instruction of authorization requests to carry out Clinical Research with
Pharmaceutical Substances, Medicaments, Vaccines and New Diagnosis Tests.
 Procedures to be adopted in the importation of products and raw materials
 The clearance, by the Sanitary Surveillance Office of the Ministry of Health, of
products imported directly or by third party means, for institutions or agencies
interested in carrying out researches or scientific investigations.
 Guidelines for the text of the "direction for use" of medicines, whose items
must be strictly followed
 List of documents needed for requesting registration of imported medicines.
 Production and trade of generic products.
 The entities or companies that intend to register vis-à-vis ANVS/MS in order
to qualify for carrying out the trials of pharmaceutical equivalence,
bioavailability and/or bioequivalence must proceed to the completion of the
specific form available on the Internet, at the following electronic address:

39. LEGISLATION
Imported Merchandise
 Technical Regulation for the purposes of
sanitary surveillance of imported merchandise.
(things for sale)
Medical Devices
 Concepts and Definitions for medical devices

40. LEGISLATION
Pharmacovigilance
 The entry, trade and exposure to consumption of goods (finished,
semi-finished or in bulk) for use in human beings that contain raw
materials obtained from the tissues/fluids of ruminant animals
 Conditions that present health risks remains forbidden in the
national territory
 Cancel the licenses of CISAPRIDE-based medicines
 Forbid the use of mercury compounds in medication
 Fabrication, distribution, trade/sale and dispensation of products that
contain the substance TERFENADINE and its salts in their formula,
be it in isolation or in association to other substances
Ports, Airports and Borders
 Technical regulation, for sanitary inspection and control in airports
and aircraft
 Technical regulation in national territory, of cargo and passengers
transportation vehicles aiming at the promotion of the epidemiological
surveillance and the control of vectors in such areas and the transport
vehicles circulating therein

41. LEGISLATION
Tobacco Products
 Norms for the listing of tobacco products.
 Tobacco leaves and tobacco products which are processed,
manufactured, transported, marketed and/or stored
throughout the territory of Brazil , and whether imported or
for purposes of export.
 Smoking products derived from tobacco and marketed in
Brazilian national territory, whether the products are
produced domestically or imported
 Maximum levels allowed of tar, nicotine and carbon monoxide
present in the mainstream smoke of cigarettes commercialized
in Brazil.
 Sets forth restrictions on the use and advertising of smoking
products, alcoholic beverages, medicines, therapeutic remedies
and pesticides
Technical Regulation - Rules for Inspections
applicable to inspect drug manufacturing
establishments
 Rules for Inspections applicable to inspect drug manufacturing
establishments

42. REFERENCE
www.anvisa.gov.br