Clipping of news on Brazilian Culture, Law and Citizenship
13/04/2012
This article was translated by an automatic translation system, and was therefore not reviewed by people.
ANVISA published on Monday, rule that requires registration holders, a series of actions to reduce the risk associated with the occurrence of problems with health products already marketed in the country. RDC Resolution No. 23 establishes the procedures and deadlines that must be followed when it appears that a health product does not meet the essential requirements of safety and efficacy.
According to the new standard is required to adopt measures called "field work" as soon as possible, whenever there evidence of any diversion of certain product quality. These actions may involve the recall of the market and aim to minimize the health risk, effectively and timely.
Among the activities described by the DRC, is the need to produce warning messages aimed at the population. The document should contain information about the problem, the product, the risk related to the case, and guidelines for health professionals, patients, users and other stakeholders.
When you need to use a vehicle for mass circulation media for the dissemination of the alert message, the registration holder must submit the message to the prior consent of ANVISA. The Agency may require revision, amendment or supplement the information presented.
The resolution also determines that the company holding the registration submits to Anvisa monitoring reports and completion of field action. Another requirement is the provision of assistance by the holders of the registry, users, patients or other persons involved in order to reduce the effects of the damage.
Companies will have a period of 360 days to conform to the norm.
Forms
The list of documents of education and the model forms shown in the DRC in 23 are described in Instruction 1, also published in the Official Gazette on Monday.
Source: ANVISA
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This article was translated by an automatic translation system, and was therefore not reviewed by people.