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Definition of Safety Variation

Update to the reference safety information, that pertains to posology, special warnings and precautions, contraindications, undesirable effects and overdose. In other words, any change that may have an impact on patient safety may be regarded as a safety variation.

What factors can trigger a safety variation in the EU/UK?

  1. Request from the Competent Authority
  2. PRAC Recommendation
  3. The outcome of PSUR Single Assessment (PSUSA)
  4. The outcome of Signal Management