Pharmacovigilance

Marketing authorization holders and their authorized representatives, as well as wholesalers of medicinal products, must maintain a pharmacovigilance system for the products for which they hold authorizations and which they distribute.

Once a medicinal product is authorized for use in the European Union (EU), the European Medicines Agency (EMA) and EU member states, its safety and efficacy are continuously monitored and action is taken if new information indicates that the medicinal product is no longer as safe and effective as it was believed to be at the time as it was considered at the time of its authorization for use.

Pharmacovigilance involves a number of routine activities, including:
- an assessment of how the risks associated with a drug will be managed and monitored once it is authorized for use;
- constant monitoring of suspected side effects reported by patients and medical professionals, identified in new clinical trials or reported in scientific publications;

- carrying out a regular assessment of the reports submitted by the marketing authorization holder on the benefit/risk ratio of the medicinal product in real life;
- assessment of the product and the results of the post-authorization safety studies required at the time of its issuance.