EMAOn the 8 January 2014, the EMA published Revision 2 of the “Guideline on Good Pharmacovigilance Practices (GVP)
The revisions to Annex I – Definitions (EMA/876333/2011 Rev 2) of the GVP Guidelines includes the following:

  • Addition of definitions consulted with the public and finalised for Module XV (Direct healthcare professional communication)
  • Addition of definitions consulted with the public and finalised for Considerations P.I (Immunisation, Immunisation anxiety-related reaction, Immunisation error-related reaction, Target population (vaccine), Vaccination, Vaccination failure, Vaccine failure, Vaccine pharmacovigilance, Vaccine product-related reaction, Vaccine quality defect-related reaction)
  • Addition of definitions from the European Union Regulatory Network Incident Management Plan for Medicines for Human Use (Crisis, Incident)
  • Amendments to the definitions of Missing information and Safety concern in order to meet EU legal requirements
  • Move of definition of Important missing information to explanatory note to definition of Missing information;
  • Addition of explanatory notes for the definition of Off-label use in accordance with Module V
  • Addition of an explanatory note on abbreviations used in the definition for Immunological medicinal product.
Further information can be found at: