ANVISANational Health Surveillance

Agency

.

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.

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."

ValuesTransparencyKnowledge

Cooperation

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.

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.

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

Centers for carrying out BA/BE shall observe the rules and technical regulations in force

BA/BE Good Practices Manual is given in two volumes

HIGHLIGHTS OF ANVISATravelers InformationHow 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.

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.

OFFICES OF ANVISA

Advisory Council Office of Ombudsman

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.

OFFICES OF ANVISAOffice 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 deadlines3. Producing monthly reports to the Collegiate Board of Directors

containing information about the steps taken and the manner in which particular issues are being addressed within the Agency.

GENERAL INFORMATION SECTIONS

The institution Overview Competencies Structure Background Contact us

GENERAL INFORMATION SECTIONS

ANVISA Informs Articles and interviews News Public consultation

GENERAL INFORMATION SECTIONS

Services (user services, database, revenues)

GENERAL INFORMATION SECTIONSAreas 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

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

THE INSTITUTIONOverviews: 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.

THE INSTITUTIONCompetencies: 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……..

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;

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.

THE INSTITUTIONBackground 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.

THE INSTITUTION

Structure of the National Health Surveillance Agency Collegiate Board of Directors

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

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

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

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

USER SERVICES

DatabaseIn 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)

USER SERVICES

Revenues The Brazilian Sanitary Surveillance Agency

provides a fee collectionservice (in Portuguese), for on-line access to a printable Fee Collection

AREAS OF ACTION1. Blood and Blood Products1.1 National Blood and Blood Products Policy 1.2 Campaign for blood donations

2. Cosmetics2.1 Legislation2.2 Technical Background 2.3 Product Notification2.4 Registration of Product

3. Drugs3.1 Controlled Medicines3.2 Registration of Medicines

4. Generic Drugs4.1 Frequently asked questions4.2 Industry4.3 Legislation

AREAS OF ACTION5. Food5.1 Legislation5.2 Inspection5.3 Registration of Products5.4 Program for calculation of Compulsory Nutritional Information on

Food and Drink Labels

6. Health Services6.1 Health Care Architecture and Design6.2 Infection Control in Health Services

7. International Affairs7.1 Overview7.2 International Agreements (Multilateral, Regional and Bilateral)7.3 National legislation X International References

8. Market Regulation

9. Medical Devices

AREAS OF ACTION10. Pharmacovigilance

10.1 Background10.2 International drug monitoring program – WHO10.3 Who are we?10.4 Structure and Relationship10.5 What we did from 2002 – 200310.6 Business plan for 2002/200310.7 Business plan for 200110.8 Marketing review 10.9 International recall monitoring10.10 Regulatory acts10.11 Publications10.12 Pharmacovigilance unit wins international award10.13 Adverse drug reaction form10.14 Contact us10.15 Banner – Technical complaints form

AREAS OF ACTION11. Ports, Air ports and Borders11.1 Overviw11.2 Airports11.3 Sanitary inspection products11.4 Borders11.5 Ports11.6 Brazil – Ballast water11.7 Banners

12. Reblas – Brazilian Laboratory network12.1 Overview12.2 Contact us

13. Snaitizing products

14. Tobaco14.1 Legislation

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

LEGISLATION

Cosmetics Definition and Classification of Personal

Hygiene Products, Cosmetics and Perfumes and other products

LEGISLATIONDrugs 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".

LEGISLATIONFood 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

LEGISLATIONGeneric 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: http://anvs.saude.gov.br

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

LEGISLATIONPharmacovigilance 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

LEGISLATIONTobacco 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

REFERENCE

www.anvisa.gov.br