Voisin Consulting Life Sciences glossary icon
Glossary

Reference safety information

Loading..
Click a letter to view all its definitions

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

M

Micro-organism

Micro-organism means any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic…

View definition
P

Post-market surveillance

All activities carried out by manufacturers in cooperation with other economic operators to institute and…

View definition