The Brazilian Agency for Health Surveillance
Public Consultation No. 05 of February 15, 2011
Federal Official Gazette of 02/16/11
The Collegiate Board of Directors of the Brazilian Agency for Health Surveillance, exercising the powers conferred upon it by Subparagraph IV of Article 11 and Article 35 of ANVISA’s Regulation approved by the Decree No. 3029 of April 16, 1999, and in view of the provisions of Subparagraph V and Paragraphs 1 and 3 of Article 54 of the Internal Regulations, approved in accordance with the Attachment I of ANVISA Ordinance No. 354 of August 11, 2006, republished in the Federal Official Gazette of August 21, 2006, in a meeting conducted on February 15, 2011,
Adopts the following Public Consultation and I, its Alternate Director and Chairman, determine its publication:
Article1It is open, from the date of publication of this Public Consultation, the period of sixty (60) days for the submission of criticism and suggestions on the Resolution proposal, which sets forth the minimum requirements regarding mandatory notice and implementation of field actions applicable to registration holders of health products in Brazil, in the Attachment.
Article2 Informs that the Resolution proposal is available in full at Anvisa’s website at and that suggestions shall be forwarded in writing, in a specific form, to one of the following addresses: Brazilian Agency for Health Surveillance/Technical Surveillance Unit, SIA Trecho 5, Area Especial 57, Brasília-DF, CEP 71.205-050; or to Fax number: (55 61) 3462-5437, or by e-mail: .
Paragraph 1 The documentation, which is the subject matter of this Public Consultation and the form to be used to send contributions shall remain available to the interested parties at the electronic pages
Paragraph 2 Contributions received shall be public and remain available to anyone at Anvisa’s website.
Paragraph 3 Contributions not sent in the form indicated in the Paragraph above or received after the deadline shall not be considered for the regulation final wording.
Article3After the period set forth in Article 1, the Brazilian Agency for Health Surveillance may make arrangements with the agencies and entities involved and those who have expressed interest in the matter, in order to appoint representatives for subsequent discussions aiming at agreeing with the final wording.
Sole Paragraph. The regulation final wording and the Contributions Analysis Report shall be available at Anvisa’s website after deliberation of the Collegiate Board of Directors.
DIRCEU BRÁS APARECIDO BARBANO
ATTACHMENT
RESOLUTION OF THE COLLEGIATE BOARD OF DIRECTORS- RDC No. XX OF XXXXXX XX, 2011.
Provides for the mandatory notification and implementation of field actions
by holders of health products registration in Brazil.
The Collegiate Board of Directors of the Brazilian Agency for Health Surveillance, exercising the powers conferred upon it by Subparagraph IV of Article 11 of the Regulation approved by Decree No. 3029 of April 16, 1999, and in view of the provisions of Subparagraph II and in Paragraphs 1 and 3 of Article 54 of the Internal Regulations, approved in accordance with the Attachment I of ANVISA Ordinance No. 354 of August 11, 2006, republished in the Federal Official Gazette of August 21, 2006, in a meeting conducted on XXXX XX, 2011,
Adopts the following Resolution of the Collegiate Board of Directors, and I, the Chairman, determine its publication:
CHAPTER I
INITIAL PROVISIONS
Section I
Subject Matter
Article1 This resolution sets out the situations that are mandatory for the execution and notification of field actions by holders of health products registration in Brazil, setting its minimum requirements.
Article2 For the purposes of this Resolution, a health product registration holder is understood as a health product registration holder with Anvisa.
Sole Paragraph. Companies, as well as other corresponding agents, holding registrations ranging from production to marketing, are jointly and severally liable for maintaining quality, safety and efficacy of health products up to the ultimate consumer.
Section II
Definitions
Article3 For the purposes of this Resolution, the following definitions are adopted:
I - Field Action: action taken by the holder of health product registration with Anvisa, aiming at reducing health risks and preventing the occurrence of adverse events related to the use of health products already marketed. Examples of field actions:
- Recall of products for correction and return to the market;
- Recall of products for destruction;
- Recall of products at their location;
- Amendment or supplementation of the product use instructions.
II - Warning Message: notice issued by the registration holder to health professionals, patients, users, the regulated industry, other stakeholders, and the community at large, whose goal is providing information about the risk of adverse events related to the use of a health product;
III - Adverse Event: any untoward effects in humans resulting from the use of a health product.
IV - Serious Adverse Event: an adverse event categorized under at least one of the following situations: (a) leads to death; (b) causes disability or permanent damage to a structure of the organism; (c) requires medical or surgical intervention in order to prevent permanent impairment of a function or structure of the organism; (d) requires the patient’s hospitalization or extended hospitalization; and (e) leads to fetal disruption or risk, fetal death or congenital anomaly.
V - Health product: product that fits in at least one of two categories described below: (a) medical products - equipment, apparatus, material, article or system of use, or medical, dental or laboratory application, intended for prevention, diagnosis, treatment, rehabilitation or contraception and that does not use pharmacological, immunological or metabolic means to perform their main function in humans; however, they can also be assisted in their functions by such means; (b) product for in vitro use diagnosis - reagents, standards, calibrators, controls, materials, devices and instruments, along with instructions for use that contribute to carry out a qualitative, quantitative or semi-quantitative determination of a sample from a human body and are not intended to accomplish any anatomical, physical or therapeutic function, that are not swallowed, injected or inoculated in human beings, which are used solely to provide information on samples obtained from the human body.
CHAPTER II
FIELD ACTIONS
Article4 The registration holder shall initiate a field action whenever a health product does not meet the safety and efficacy requirements established.
Paragraph 1 The field action shall be planned and implemented with the objective of minimizing the health risk as effectively as possible.
Paragraph 2 The field action implementation shall also lead to immediate suspension of the concerned marketed batch or series.
Paragraph 3 In situations where the health product, subject to the field action, was or is still in use, the registration holder shall provide assistance to users, patients or other concerned people, in order to make acceptable the risk associated to the use of the product, or reduce the effects of damages already occurred.
Article5 The registration holder shall prepare and maintain current written operational procedures relevant to the field actions that are under the company’s responsibility.
Article6 The Brazilian Agency for Health Surveillance (SNVS) may determine, when a health risk is identified, the execution of field actions deemed appropriate, regardless of initiatives taken by the registration holder.
CHAPTER III
WARNING MESSAGE TO USERS
Article7 The registration holder shall send warning messages to users of health products, subject to the field action, which shall be clearly and objectively expressed and contain information about:
I - The problem;
II - The product, including batch identification, serial number and model concerned;
III - Risks;
IV - Actions taken by the company; and
V - Guidelines for users.
Paragraph 1 The registration holder shall select and use the most effective communication mean(s) to promote the warning message.
Paragraph 2 The warning message shall be sent to users, whenever the company performs a field action, even in cases when the notification to SNVS is not mandatory.
CHAPTER IV
FIELD ACTION NOTIFICATION
Article8 The registration holder shall notify SNVS within 48 hours, from problem awareness,about the field action implementation that involve a health product, whenever the risk of serious adverse event resulting from the product use or someone’s exposure to it, is identified. Notification to SNVS shall contain at least:
I - Information on the registration holder;
II - Product Information;
III - Problem description;
IV - Problem risk analysis;
V - List of existing batches or series in Brazil;
VI - Distribution map of the affected product in Brazil (product traceability);
VII - Action plan (with actions to be taken and implementation schedule);
VIII - A copy of the warning message to the user and information regarding the media used to promote it;
IX - Name of the person in charge of the field actions.
Paragraph 1 Notification shall be made using a specific form to be defined by Anvisa, by means of a normative instruction.
Paragraph 2 Anvisa may request revision, amendment or supplementation of the information submitted by the registration holder, including changes to dates provided in the action plan.
Article9 In case of field actions fitting the criteria for the mandatory notification set forth in this Resolution, whenever it is necessary to use large circulation media vehicles to promote the warning message to users, the registration holder shall submit information about the warning message for prior approval of Anvisa, as set by Article 41-B of Law 9782/99.
Paragraph 1 Submission to Anvisa of information discussed in the main section of this article shall be performed within 72 hours, counted from the problem awareness.
Paragraph 2 Submission to Anvisa of information discussed in the main section of this article shall be performed using a specific form, to be defined by Anvisa, by means of a normative instruction, and the registration holder is subject to the payment of a fee as set forth in the RDC 222 of December 28, 2006.
Paragraph 3 After filing the form above, Anvisa may approve the warning message proposed by the registration holder, or indicate necessary corrections.
Paragraph 4 After approval by Anvisa, the registration holder shall immediately disclose the warning message to the population at large.
Article10 When deemed necessary, Anvisa may determine the registration holder to change format, content or the media to be used in the warning message for the users.
CHAPTER V
RESPONSIBILITIES OF DISTRIBUTORS
Article11 Health products distributors shall timely send to the registration holder a distribution map and other information required to perform field actions and promote the warning message for the users.
CHAPTER VI
REPORTS
Article12 With respect to field actions of mandatory notification, provided herein, the registration holder shall submit monitoring reports and field action completion reports to SNVS, as well as additional information deemed necessary.
Paragraph 1 The first field action monitoring report shall be submitted within 30 (thirty) days from the date of notification to SNVS.
Paragraph 2 Monitoring reports following the first one, as well as the final report shall be submitted on dates stated in the action plan, presented by the registration holder in its notification to the SNVS.
Paragraph 3 Along with the completion report, a copy of documentation evidencing the field action completion shall be sent.
Paragraph 4 Field action monitoring reports shall be sent in a specific format to be defined by Anvisa, by means of a normative instruction.
Article13 Anvisa may require submission of monitoring reports and completion report on dates different from those reported in the company’s action plan.
Article14 The registration holder shall submit, semi-annually, to SNVS, a report containing a summary of all field actions, whetherof mandatory notification or not, it undertook in the period (six months).
Sole Paragraph. The report mentioned in the main section of this Article shall be sent in a specific format, to be defined by Anvisa, by means of a normative instruction.
CHAPTER VII
FINAL AND TEMPORARY PROVISIONS
Article15 Recalled products shall be identified and segregated into separate and safe areas until the definition of its final destination.
Article16 Destruction of health products recalled shall be under the responsibility of the registration holder, in accordance with standards in force, related to waste disposal.
Article17 With respect to field actions involving health products, regardless of the mandatory notification to SNVS, the registration holder shall maintain an updated file of documents and records, structured in a way to ensure information traceability and fast data recovery.
Sole Paragraph. In the file referred to in the main section of this Article, there shall be included all documents and records related to field actions performed by the registration holder, including registrations certifying the completion of such field actions.
Article18 Failure to comply with the provisions of this Resolution constitutes a sanitary violation, pursuant to Law No. 6437 of August 20, 1977, without prejudice to the applicable civil, administrative and criminal responsibilities.
Article19 Anvisa and other SNVS departments shall be liable, within their agreed powers and responsibilities, for taking measures or procedures for cases not set forth in this Resolution.
Article20 The period of 360 (three hundred sixty) days is set for the health product registration holders to comply with this Resolution.
Article21 This Resolution enters into force when published.
DIRCEU BRÁS APARECIDO BARBANO