The role of the local contact for pharmacovigilance issues

The role of the local contact for pharmacovigilance issues

Following the developments of the pharmacovigilance legislations at EU level Bulgaria imposed the requirement for the appointment by the marketing authorisation holders (MAHs) of a local contact person for pharmacovigilance issues (LPPV) for medicinal products for human use. The national legislation does not contain detailed requirements for the role and functions of the LPPV: they depend […]