ANVISA National Health Surveillance Agency

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ANVISANational Health Surveillance Agency
Presented by Aarohi Shah M. Pharm L.M.C.P.
Department of Pharmaceutics and Pharmaceutical
Technology
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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.

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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

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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.

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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.

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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

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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.

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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.

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OFFICES OF ANVISA

• Advisory Council
• Office of Ombudsman

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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.

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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
• 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
• Providing responses to the demands within the
  agreed deadlines
• 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.

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General Information Sections

• The institution
• Overview
• Competencies
• Structure
• Background
• Contact us

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General Information Sections

• ANVISA Informs
• Articles and interviews
• News
• Public consultation

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General Information Sections

• Services
• (user services, database, revenues)

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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

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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

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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.

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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..

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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

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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.

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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.

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The Institution

• Structure of the National Health Surveillance
  Agency

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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

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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

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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

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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)

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User services

• Revenues
• The Brazilian Sanitary Surveillance Agency
  provides a fee collectionservice (in
  Portuguese), for on-line access to a printable
  Fee Collection

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Areas of action

• 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

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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
• 9. Medical Devices

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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

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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
• 14.1 Legislation

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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

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Legislation

• Cosmetics
• Definition and Classification of Personal Hygiene
  Products, Cosmetics and Perfumes and other
  products

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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".

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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

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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
  http//anvs.saude.gov.br

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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

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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

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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

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Reference

• www.anvisa.gov.br

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THANK YOU