Guideline on good pharmacovigilance practice (GVP)s

Use outside the marketing authorisation includes off -label use, overdose, misuse, abuse and medication errors (see GVP Annex I), which are all important aspects related to the pattern of utilisation of medicines in the paediatric population (see P.IV.A.1.4.).

  Medication, Authorisation

Guideline on good pharmacovigilance practices (GVP)

Guideline on good pharmacovigilance practices (GVP) – Module VI (Rev 2) EMA/873138/2011 Rev 2 Page 5/144 VI. Appendix 4 Submission of ICSRs to the World Health Organization