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Characteristics of the reports
 
Voluntary and spontaneous reports of adverse reactions of drug products and the suspicions of quality defects are reported to the National Pharmacovigilance System by means of a report form. The report form is a printed form in which the following data should be filled in:
  • 1. Patient´s data: weight, age, gender.
  • 2. Description of the adverse event and supplementary data.
  • 3. Data of the suspected drug product: generic name, dose, therapy initiation and end, indication of use, expiration, batch number, etc.
  • 4. Reporter´s data.
Reports are confidential regarding the identity of the person affected and the reporter.
 
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