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Glossary

Reference safety information

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In periodic benefit-risk evaluation reports for medicinal products, all relevant safety information contained in the reference product information (e.g. the company core data sheet) prepared by the marketing authorization holder and which the marketing authorization holder requires to be listed in all countries where it markets the product, except when the local regulatory authority specifically requires a modification. 

Other glossary definitions

V

Voluntary Harmonization Procedure (VHP)

When a sponsor wishes to carry out a clinical trial in two or more EU…

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U

Unanticipated Adverse Device Effect (UADE)

Any serious adverse effect on health or safety or any life-threatening problem or death caused…

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