Responsible for pharmacovigilance
Role and responsibilities of the person responsible for pharmacovigilance (QPPV: Qualified Person responsible for Pharmacovigilance)
The role and responsibilities of the person responsible for pharmacovigilance are detailed in Eudralex "Volume 9B of The Rules Governing Medicinal Products in the European Union - Guidelines on Pharmacovigilance for Medicinal Products for Human Use ."
Administrative formalities in connection with the person responsible for pharmacovigilance
• The holder of a marketing authorisation (MA) must be assisted permanently and continuously by a qualified person responsible for pharmacovigilance who resides in the EEA (European Economic Area)
• The holder of a marketing authorisation (MA) must also be assisted by a local contact person.
Circular 601 (and annex I and annex II) gives more information regarding the obligation for the MAH to notify the local contact person and current information regarding veterinary pharmacovigilance to the FAMHP.
For more information regarding this Circular Letter, see also the FAQ.