Qualified person 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 9A of The Rules Governing Medicinal Products in the European Union - Guidelines on Pharmacovigilance for Medicinal Products for Human Use."

These are mainly:

• The implementation and management of a pharmacovigilance system in the company which holds the MAA to ensure that all information relating to suspected adverse reactions to medicinal products are collected and processed to be available at least in a precise location in the Community;

• The preparation for the attention of the competent authorities of notification of serious adverse effects (ICSRs), periodic safety reports (PSURs) and reports on studies of post-authorisation safety (PASS);

• The making available, at the request of BCPH of any information necessary to evaluate the benefit / risk balance of medicines, including information relating to PASS

• Being the single contact point with authorities on pharmacovigilance, 24/24;

• Being the contact point of the MAA holder as part of pharmacovigilance inspections.

Administrative formalities in connection with the person responsible for pharmacovigilance

• The person responsible for pharmacovigilance must be holder of a diploma in either pharmacy or of master in pharmaceutical sciences, or in either medicine or of master in medicine, or in either veterinary medicine or of master in veterinary medicine; this person must be registered on a list drawn up and kept updated by the Minister or his representative, en must provide that he has at least one year experience in the field of 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 Community and whom's contact details are reported to the FAMHP by letter, dated and signed by both parties ;

• Any modification concerning these data must be reported to the FAMHP as soon as possible to the following address : PhVInsp@fagg-afmps.be.

Circular 520 (+ form / form), regarding the pharmacovigilance inspections, describes accurately who these formalities should be met.

Circular 544 (updated following the Royal Decree of 16 March 2010, amending Articles 68 § 2 and 195 of the Royal Decree of 14 December 2006) (+ Annex) gives information regarding the application to be registered as the person responsible for pharmacovigilance of medicinal products for human or veterinary use.

Circular 545 gives information regarding the reporting to the FAMHP by the MA or registration holders of the person responsible for human or veterinary pharmacovigilance.


Contact: PhVInsp@fagg-afmps.be  














Last updated on 16/12/2020