NATIONAL HEALTH SURVEILLANCE AGENCY  
www.anvisa.gov.br  
Public consultation No 2 of 4 January 2008  
Official Gazette of Brazil (DOU) of 07/01/2008  
The Collegiate Board of the National Health Surveillance Agency (ANVIS A), pursuant 
to the powers conferred on it by Article 11, indent IV and Article 35 of the ANVISA 
Regulation approved by Decree No 3.029 of 16 April 1999, and in accordance with 
Indent V and paragraphs 1 and 3 of Article 54 of the Internal Regulations appro ved under 
Annex I of ANVISA Order No 354 of 11 August 2006, republished in the DOU on 21 
August 2006, at a meeting held on 20 December 2007 , 
Hereby announces the following public consultation and I, as Director -President, order 
its publication:  
Article 1   
A period of 60 (sixty) days is provided from the date of publication of this Public 
Consultation in which to submit criticisms and suggestions concerning the annexed draft 
decision on pharma covigilance rules  for drug registration holders and legal 
represen tatives of pharmaceutical companies.  
Article 2   
The full draft Technical Regulation  will be available during the consultation period on 
the website www.anvisa.gov.br . Suggestions must be sent in writing to the Nati onal 
Health Surveillance  Agency either by post (ANVISA , SEPN 515, Bloco B, Ed. Ômega, 
Asa Norte, Brasilia, DF, CEP 70.770. 541), by fax (061 3448 12 19) or by e -mail 
(farmacovigilancia@anvisa.gov.br ). 
Article 3   
At the end of the period indicated in Article 1, the National H ealth Surveillance Agency 
will consolidate the final wording of the decision.  
DIRCEU RAPOSO DE MELLO  
ANNEX  
DECISION OF THE COLLEGIATE BOARD – RDC No XX of XXXXX 2008  
on pharmacovigila nce rules  for drug registration holders  and legal representatives of 
pharmaceutical companies.  
The Collegiate Board of the National Health Surveillance Agency (ANVISA), pursuant 
to the powers conferred on it by Article 11, indent IV of the ANVISA Regulatio n 
approved by Decree No 3.029 of 16 April 1999, and in accordance with Indent II and 
paragraphs 1 and 3 of Article 54 of the Internal Regulations approved under Annex I of 
ANVISA Order No 354 of 11 August 2006, republished in the DOU on 21 August 2006, 
at a meeting held on XXXX of XXXX 200X, and  
Whereas health is the right of all people and a duty of the State, guaranteed through 
social and economic policies aimed at reducing the risk of illness and other ailments and 
providing universal and equal access  to measures  and services to promote, protect and evansjo  ENTR -2008 -00475 -00-00-EN-TRA -00 (PT)  
-2- restore health, in accordance with Article 196 of the Constitution of the Federative 
Republic of Brazil of 5 O ctober 19 88; 
Whereas health measures  and services are of public importance, in accordance with 
Article 197 of the Constitution, whereby, under law, the public authorities are responsible 
for health regulation, supervision and control;  
Having regard to Article 79 of Law No 6.360 of 23 September 1976 and Article 139 of 
Decree No 79.094 of 5 January 1977, which stipulate that all reports concerning 
accidents and adverse reactions caused by medicinal products must be sent to the 
competent health surveillance body of the Ministry of Health;  
Having regard to the provisions of Order MS (Ministry of Health) No 577 of 20 
December 1978, laying down that Brazil, as a Member State of the World Health 
Organisation, must notify this body of the adoption of any measure , taken as a result of a 
national evaluation,  restricting or prohibiting the use of any medicinal prod uct that has 
serious harmfu l effects ; 
Having regard to National Health Council Decision No 3 of 28 June 1989, 
recommending that the National Health Surveillance System set up and maintain an 
effective Pharmacovigilance System regulating the prompt notifica tion of the incidence 
of side effects resulting from the use of medicinal products in the country;  
Whereas health is a fundamental right of human beings and the State must provide the 
conditions needed for people to exercise this right fully, in accordance  with Article 2 of 
the Organic Health Law  (LOS) , Law No 8.080 of 19 September 1990;  
Having regard to the priorities of the National Policy on Medicinal Products, defined by 
Order No 3.916/MS/GM of 30 October 1998, which includes pharmacovigilance 
measures to ensure  that the rational use of medicinal products is promoted;  
Having regard to Law No 9.782 of 26 January 1999 , which designed  the National Health 
Surveillance System (SNVS), created ANVISA and established  the powers  of the States 
and Municipalities f or controlling  and inspecting health -related products and services, 
and its Article 7, Indent XVIII , which makes ANVISA responsible for setting up, 
coordinating and monitoring the toxicovigilance and pharmacovigilance systems , and 
Article 8 , which makes AN VISA responsible for regulating, controlling and inspecting 
products and services involving a risk to public health;  
Having regard to Order No 696/MS of 7 May 2001, which set up  the National Centre for 
Monitoring Medicinal Products (CNMM), based in the ANV ISA Pharmacovigilance 
Unit;  
Whereas Brazil was accepted as the 62nd Member Country of the World Health 
Organisation ’s Drug Monitoring Programme in May 2001;  
Having regard to RDC No 55/2005 of 17/03/2005 on the minimum requirements laid 
down for undertaking s holding drug registrations  (producers or importers)  as regards  
their obligation to notify the competent health authorities and consumers  and  to take 
steps to recall medicinal products , if there are  sufficient signs or evidence of 
compromised quality  to indicate that these products  will endanger, harm or affect health, 
and to recall medicinal products if registration has been withdrawn for reasons relating to 
safety or effectiveness;  evansjo  ENTR -2008 -00475 -00-00-EN-TRA -00 (PT)  
-3- Having regard to Service Bulletin No 16 of 15/03/2007, page 7, Chapter VI I, Section II , 
setting up the Pharmacovigilance Administration Body ; 
Having regard to the need to detect new signs relating to  the safety of medicinal products 
distributed or placed on the market in Brazil;  
Having regard to the need to promote the identifi cation and the anticipation of the effect 
on users’ health of problems concerning  distributed or marketed medicinal products;  
Having regard to the need to have information available, covering a variety of details, 
concerning the pharmacovigilance procedure s to be developed by the drug registration 
holders  and legal representatives of pharmaceutical firms in Brazil with regard to 
pharmacovigilance measures ,  
Hereby adopts the following Decision of the Collegiate Board and I, as Director -
President, order its publication:  
Chapter 1 – Initial provisions  
Article 1   
For the purposes of this decision, pharmacovigilance means the activities relating to the 
detection, evaluation , understanding and prevention of adverse effects or other problems 
relating to  the use of  medicinal products, in accordance with the following description:  
I  Adverse reactions to medicinal products;  
II  Adverse events caused by suspected compromised  medicinal -product quality;  
III  Medication mistakes, potential and real;  
IV Adverse events cau sed by off -label indications;  
V  Misuse  of medicinal products;  
VI  Interaction of medicinal products;  
VII  Therapeutic failures, total or partial;  
VIII  Poisonings.  
Article 2   
This decision applies to all drug registration holders  and legal representatives  of 
pharmaceutical companies of medicinal products for human use distributed or placed on 
the market in Brazil.  
Article 3   
Drug registration holders and legal representatives of pharmaceutical companies must 
have a pharmacovigilance system located in Brazi l that complies  with the following 
criteria:  
I. The system must be coordinated by a professional with proven qualifications 
responsible for pharmacovigilance and it must have a physical structure and a system of 
documentary organisation that is able to dea l with the proposed activities . evansjo  ENTR -2008 -00475 -00-00-EN-TRA -00 (PT)  
-4- II. There must be a document describing in detail the pharmacovigilance system set up in 
the company, signed by a member of staff responsible for pharmacovigilance and by the 
company’s technical m anager or legal representati ve. This document must be available in 
the company so that an authenticated copy can be sent to the SNVS when required . 
III. At the health authority’s request, in the field of pharmacovigilance, the drug 
registration holder must provide all the data relati ng to the volume of production, sales, 
dispatch es, return s, donation s, prescriptions or the exposure of patients to the medicinal 
product, indicating the unit -time with the daily dosage used . Information on the 
calculation method must be provided and the f ollowing data may be used: patient -day, 
number of prescriptions, number  of dos age units, sales units, defined daily dosage, daily 
dosage, production volume, among others , where appropriate, or any other data on the 
notifications received regarding the comp any’s products.  
IV. Drug registration holders and legal representatives of pharmaceutical companies may 
not consult health establishments, health professionals or consumers regarding 
pharmacovigilance matters involving their medicinal products unless the S NVS is 
notified in advance or at the same time . They must ensure that this information is 
presented objectively and that it is not misleading, without prejudice to the  provisions on 
the communication of publicity and advertising of medicinal products.  
V. T he measures adopted by the drug registration holders and legal representatives of 
pharmaceutical companies or other measures taken by regulatory agencies in relation to 
their pharmaceutical products involving  safety issues must be reported to the CNMM 
within 72 hours, notwithstanding the need to provide information to other  ANVISA  
areas , including the technical -scientific reasons justifying  the measures taken set out in 
report form.  
Chapter 2 – Duties and routines  
Article 4   
Drug registration holders and le gal representatives of pharmaceutical companies must 
carry out the following duties:  
I. Observe  the pharmacovigilance rules to be regulated by ANVISA;  
II. Develop an institutional pharmacovigilance system that: 
i) Receive s, codif ies, evaluate s the seriousn ess and likelihood of adverse reactions 
reported in notifications and carr ies out the case follow -up, in order to obtain all possible  
information, which will be sent to the SNVS;  
ii) Ha s a doctor or pharmacist with proven qualifications to develop the 
pharmacovigilance of its medicinal products , and a manager;  
iii) Has a system that ensures the systematic, up -to-date and routine registration of the 
activities and information relating to the notifications of adverse events received;  
iv) Files notifications s ystematically, in such a way that they can be traced and 
information can be recovered quickly;  
v) Sends the CNMM the notifications received in relation to its medicinal products , 
either electronically or by means of regular  reports depending on the case;  evansjo  ENTR -2008 -00475 -00-00-EN-TRA -00 (PT)  
-5- vi) Maintains a procedure making it possible to identify safety signs concerning its 
products and informs ANVISA as quickly as possible of any measures adopted;  
vii) Proposes and implements measure s to control dangers and damage  to its products;  
viii) Prod uces regular reports on the safety of its products;  
ix) Implements internal auditing measures and measures in preparation  for the ANVISA 
inspection.  
III. Propose  and implement measures to encourage health professionals and consumers t o 
make notifications, guarant eeing their confidentiality and forward ing the notifications to 
the SNVS;  
IV. Assist health professionals,  providing information regarding the use of their 
medicinal products or other matters concerning adverse reactions and problems involving 
their medicinal products, in order to promote their safe and rational use.  
V. Propose or conduct studies on the use of medicinal products , 
pharmacoepidemiological studies or other additional research when required or 
requested.  
VI. Guarantee  a prompt response t o any query made by the health authority for additional 
information needed to address  the benefit -risk relationship of medicinal products.  
Chapter 3 – Notification  
Article 5   
Notifications of suspected adverse reactions to medicinal products shall respect the 
criteria and deadlines indicated below:  
I. Drug registration holders and legal representatives of pharmaceutical companies must 
notify ANVISA electronically in accordance with the provisions of Articles 8 and 9 of 
this Decision.  
II. Drug registration h olders and legal representatives of pharmaceutical companies must 
notify the SNVS as quickly as possible of any suspected unexpected , serious or fatal 
adverse reaction  – even if it is described in the package leaflet – that occurs in national 
territory . The notification must be provided within 7 (seven) days of the date on which 
this information was received.  
III. Drug registration holders and legal representatives of pharmaceutical companies must 
notify the SNVS as quickly as possible of any suspected expe cted adverse reaction or 
unexpected non -serious reaction that occurs in national territory . The notification must be 
provided within 15 days of the date on which this information was received  
IV. Notifications of expected non -serious reactions must be incl uded in the regular safety 
report.  
V. Notifications of undescribed serious adverse reactions that occur in other countries 
must be detailed in the regular safety report.  
VI. Additional information on the development of the serious or unexpected adverse 
reaction may be communicated using a form identical to the first one up to 10 days af ter evansjo  ENTR -2008 -00475 -00-00-EN-TRA -00 (PT)  
-6- the initial  notification. This item  must be identified as a ‘Follow -up notification’ , 
confirming the existence of the earlier  notification.  
VII. Follow -up notifications may be sent repeatedly until a final clinical conclusion to the 
notified case is obtained or until no further information is available.  
Article 6   
With regard to the origin of the notification received by drug registration holders and 
legal representatives  of pharmaceutical companies, it is laid down that:  
I. The SNVS must be sent notifications of adverse events  reported by health 
professionals.  
II. The SNVS must be sent notifications of adverse events  reported by users and 
evaluated by a health professiona l, even if the health professional in question works f or 
the company of the drug registration holder  or legal representative . 
Sole paragraph   
If a notification of an adverse event  reported by a user or lay person, even without the 
prior evaluation of a hea lth professional, gives rise to  a safety sign , the notification must 
be sent to the SNVS, indicating that the primary notifier is a user or not a health 
professional.  
Article 7   
With regard to notifications concerning the suspected loss of effectiveness of  medicinal 
products, once consideration is given to the information in the package leaflet and the 
patient’s clinical conditions, the notifications must be sent as quickly as possible, within 
15 days of the date on which the secondary notifier received thi s information , when this 
involves:  
I. Medicinal products used to treat serious or life -threatening illnesses;  
II. Vaccines;  
III. Contraceptives;  
IV. Other medicinal products losing their effectiveness or where there is evidence of 
compromised quality.  
Article 8   
Drug registration holders and legal representatives of pharmaceutical companies must 
use the International Code of Diseases (10th or subsequent edition) for medical 
terminology and , for adverse reactions, databases compatible with  WHO -ART (World 
Health Organisation – Adverse Reaction Terminology) when  sending reports and 
notifications to the SNVS.  
Sole paragraph   
Users of the MedDRA system may use the file called ‘Bridge’ to transfer their data in 
XML format to the electronic system.  
Article 9   
Failu re to comply with the deadlines laid down for notifications does not mean that 
notifications do not have to be sent once  the deadlines have passed.  evansjo  ENTR -2008 -00475 -00-00-EN-TRA -00 (PT)  
-7- Chapter 4 – Transmission of notifications  
Article 10   
Notifications from drug registration holders and lega l representatives of pharmaceutical 
companies concerning adverse events involving medicinal products must be sent to the 
SNVS electronic notification system.  
Sole p aragraph   
Each company must have an electronic system administrator and the administrator is  
responsible for the passwords . 
Article 11   
Drug registration holders and legal representatives of pharmaceutical companies wishing 
to send notifications in batches or even individually, so that they can use their own 
pharmacovigilance computer systems, mu st process  files in XML format, with the 
notifications of adverse events.  
Chapter 5 – Periodic safety reports  
Article 1 2  
With regard to d rug registration holders and legal representatives of pharmaceutical 
companies  of new or innovative medicinal products  registered after 1 January 2008, in 
addition to complying with the provisions set out above, they must send a 
Pharmacovigilance Report for each product in the form of an official document, 
respecting the intervals and limit of 60 days after expiry of the deadline laid down in the 
following indents:  
I. Whenever requested by ANVISA;  
II. Every six months, during the first two years after registration is granted;  
III. Every year, until the first renewal (three subsequent years);  
IV. On the occasion of subseque nt renewals.  
Chapter 6 – Pharmacovigilance audit  
Article 13   
Drug registration holders and legal representatives of pharmaceutical companies may be 
subject to an audit , whenever it is deemed necessary by the SNVS, which will evaluate 
compliance with this d ecision  by means of either a planned inspection programme or 
occasional inspections.  
Article 14   
Drug registration holders and legal representatives of pharmaceutical companies must 
carry out  a self inspection relating to pharmacovigilance duties on a regu lar basis and at 
least once a year.  
Chapter 7 – Phase IV studies, post -registration  
Article 15   
Companies and institutions responsible for conducting clinical research carried out 
during the post -registration period regarded  as Phase IV clinical trials mus t send 
notifications of suspected serious or unexpected adverse reactions that occur in national evansjo  ENTR -2008 -00475 -00-00-EN-TRA -00 (PT)  
-8- territory as quickly  as possible, within 15 days of the date on which the researcher or 
sponsor of the study learns of this information . 
Article 16   
Other susp ected adverse reactions identified during Phase IV studies must be sent in 
report form.  
Chapter 8 – Final provisions  
Article 17   
ANVISA shall publish specific technical guidelines supplementing this Decision if 
necessary.  
Article 18   
Drug registration hold ers and legal representatives of pharmaceutical companies shall be 
permitted to hire a third party, whether a person or organisation, to implement one or 
more of the pharmacovigilance duties and functions set out in this Decision.  
Article 19   
The creation of groups of companies shall be permitted for the purposes of implementing 
one of more of the pharmacovigilance duties and functions set out in this Decision.  
Article 20   
The CNMM shall send data regularly on  adverse reactions to medicinal products to the 
World Health Organisation’s International Drug Monitoring Programme.  
Article 21   
The Pharmacovigilance Administration Body/Vigilance Nucleus (NUVIG), within the 
scope of its powers, shall be responsible for adopting  measures or procedures for cases 
not cov ered by this Decision.  
Article 22   
If urgent action is needed to protect public health, ANVISA may suspend the registration 
of a medicinal product or adopt other regulatory measures provided for in law.  
Article 23   
Notwithstanding other legal measures, inc luding those of a penal nature, which  may be 
applied to the technical and legal representatives, the company shall be liable in 
administrative and civil  law for health offences resulting from the failure to respect the 
provisions of this Decision and other  additional legislation, in accordance with Law No 
6.437 of 20 August 1977.  
Article 24   
A deadline of 270 days is laid down for adapting to this Decision.  
Article 25   
This Decision shall enter into force on the day of its publication.  
DIRCEU RAPOSO DE MELL O