Transcript Slide 1

ANVISA
National Health Surveillance
Agency
Presented by:
Aarohi Shah
M. Pharm
L.M.C.P.
Department of Pharmaceutics and Pharmaceutical
Technology
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”.
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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."
• Values
Transparency
Knowledge
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 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.
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
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Advisory Council
Office of Ombudsman
OFFICES OF ANVISA
Advisory Council
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The Advisory Council is a collegiate body comprises
representatives of public administration institutions,
organized civil society and the scientific community.
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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.
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The Council convenes every three months.
OFFICES OF ANVISA
Office of Ombudsman
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The Office of the Ombudsman is a communication channel through which
the population speaks up and the Institution responds, informs and
educates.
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The Ombudsman is nominated by the Minister of the Health and
appointed by the President of the Republic for a two-year term.
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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.
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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 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 Sections
Areas of action
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Blood and blood products
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Cosmetics
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Drugs
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Generic drugs
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Food
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Heath services
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International affairs
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Market regulation
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Medical devices
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Pharmacovigilance
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Ports, airports and borders
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Reblas- Brazilian Laboratory Network
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Sanitization products
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Tobaco
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Toxicology
General Information Sections
Legislation
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Cosmetics
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Drugs
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Food
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Generic Drugs
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Imported Merchandise
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Medical Devices
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Pharmacovigilance
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Ports, Airports and Borders
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Tobacco Products
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Technical Regulation - Rules for Inspections applicable to
inspect drug manufacturing establishments
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.
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……..
The Institution
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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 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.
The Institution
Structure of the National Health Surveillance Agency
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Collegiate Board of Directors
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Advisory Center for Strategic Management
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Social and Institutional Communication Advisory Nucleus
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Center for Surveillance of Adverse Events and Quality Deviations
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Office of the Attorney
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Internal Affairs Office
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Office of the Ombudsman
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Advisory Council
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Committee for Management of Sanitary Surveillance Information System
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Committee for Policy on Human Resources for Sanitary Surveillance
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Sector Committee for Processes and Debureaucratization
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Committee for Decentralization of Sanitary Surveillance Actions
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Audit Office
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Advisory Office for Decentralization of Sanitary Surveillance Actions
The Institution
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Advisory Office for Institutional Relations
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General Office of Administrative and Financial Management
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General Office of Blood, other Tissues, Cells and Organs
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General Office of Cosmetics
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General Office of Drugs
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General Office of Economic Regulation and Market Monitoring
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General Office of Foods
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General Office of Health Services Technology
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General Office of Inspection and Control of Inputs, Drugs and Products
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General Office of International Relations
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General Office of Knowledge and Documentation Management
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General Office of Laboratories of Public Health
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General Office of Medical Devices Technology
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General Office of Ports, Airports and Borders
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General Office of Sanitizing Products
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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
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Petitions
required documents
registration application processes
import of products
company operation authorization
payment of sanitary surveillance inspection fees
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)
User services
Revenues
• The Brazilian Sanitary Surveillance
Agency provides a fee collection
service (in Portuguese), for on-line
access to a printable Fee Collection
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
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
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
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
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
Legislation
Drugs
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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".
Legislation
Food
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Obligatory nutritional labeling of packaged foods and beverages
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Packaged food and beverage serving size
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Manual of basic procedures for registration and exemption from
obligatory registration of food products
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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
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Technical regulation on procedures for registration of foods with
functional and or health claims on their labels.
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Technical regulation establishing the basic guidelines for analysis
and proof of functional and or health claims on food labels
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Technical regulation establishing the basic guidelines for
evaluation of risk and safety of foods
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Technical regulation on procedures for registration of foods and or
new ingredients
Legislation
Generic drugs
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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
Legislation
Pharmacovigilance
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The entry, trade and exposure to consumption of goods (finished, semifinished 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
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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
Legislation
Tobacco Products
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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
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Technical Regulation - Rules for Inspections applicable to
inspect drug manufacturing establishments
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Rules for Inspections applicable to inspect drug manufacturing
establishments
Reference
www.anvisa.gov.br