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Each ppharma vigilanceharmaceutical company is legally obliged to create a pharmacovigilance system for the purpose of collecting and evaluating the effects of suspected adverse reactions. This system must respect the principles set out in the Good Pharmacovigilance Practices (GVP).
The holder of the marketing authorization must ensure that he has established an appropriate system of pharmacovigilance and risk management in order to assume the responsibility for its products placed on the market and to ensure the appropriate actions.

The goals in pharmacovigilance are:

  • research and information on unknown or poorly documented adverse reactions
  • the improvement of knowledge of the security profile

Every pharmaceutical company shall designate a Qualified Person responsible for pharmacovigilance.

A pharmacist with sufficient experience in this field may seek recognition as a person in charge for pharmacovigilance with the FAMHP.

The following pharmacovigilance system processes must be guaranteed under supervision:

  • The establishment and maintenance of a system that collects all information relating to an adverse reaction reported to the company staff and to the pharmaceutical sales representatives and which centralizes these data in a EU databank,
  • Conducting an overall assessment of pharmacovigilance throughout the life of the product,
  • The preparation of reports about authorized products for the authorities,
  • Individual Case Safety Reports (ICSR’s),
  • Periodic Safety Update Reports (PSUR’s),
  • Reports of safety studies funded by the company after obtaining the MA.
  • Providing answers to questions from the authorities as part of the assessment of the drugs risk/benefit ratio.