The role of the local contact for pharmacovigilance issues
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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 on the PV setup adopted by the concerned MAH. The MAH could assign to the LPPV functions related to the case assessment or medical review or the LPPV could have just limited functions as a local point of contact for pharmacovigilance.

An example of some of the functions of the LPPV is given in the scheme below.


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Bulgarian Drug Agency, Healthcare Professionals, Consumers, Sales Force, ICSR, DHPС, PSUR, risk minimisation materials, follow-up, EudraVigilance, AEs, ADRs, quality complaints, events of special interest, overdose, abuse, off-label use, misuse, medication error, occupational exposure, Literature Search Provider, Local Contact Person, pharmacovigilance