Glossary

Safety Specification

This part of an RMP provides a synopsis of a medicinal product’s safety. It should be a summary of:

  • The important identified risks
  • Important potential risks
  • Missing information

It should also address:

  • Populations potentially at risk (where the product is likely to be used in labelled and off-labelled use)
  • Safety questions which warrant further investigation during the post-authorization period

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