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New EU Pharmacovigilance Legislation
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Reporting Suspected Adverse Reactions
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www.adrreports.eu
New Legislation Concerning Falsified Medicines
New EU Pharmacovigilance Legislation
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Guidance for Marketing Authorisation Holders
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Reporting Suspected Adverse Reactions
www.adrreports.eu
Medicines under Additional Monitoring
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www.adrreports.eu
The European Medicines Agency website
www.adrreports.eu
is a database of suspected adverse drug reactions (or side effects) for authorised medicines in the European Economic Area (EEA). Currently the data only relates to medicines approved by the European Commission (through the centralised authorisation procedure).
The publication of reports of suspected side effects should not be interpreted as meaning that the medicine or the active substance caused the reaction or is unsafe to use. Only a detailed evaluation and scientific assessment of all available data allows for robust conclusions to be drawn on the benefits and risks of a medicine.
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