Pharmacovigilance Glossary Terms

SIGNAL: Information provided by marketing experience, investigations or different sources that suggest a plausible causal relationship, or provide new information on a previously known relationship, between a medicinal product and an event, both adverse or beneficial.

Safety signals are especially relevant as they can lead to new medicinal product risk identification so depending on its seriousness and frequency, further MAH actions may be required to confirm the hypothesis.

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