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-authorization 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 have a legal diploma, either a pharmacist or master in pharmaceutical sciences, either a doctor or master in medicine and must be entered on a list established and maintained by the Minister or his delegate and have proven experience of at least one year in the field of pharmacovigilance;

• The MAA holder requires one permanent and continuous person responsible for pharmacovigilance residing within the Community and whose details will be communicated to BCPH by letter dated and signed by both parties ;

• Any change of the known FAMHP data will be referred in the shortest time to BCPH, at PhVInsp@fagg-afmps.be.

Circular 520 (PDF, 146.55 Kb) (+ form (DOC, 217.5 Kb) / form (PDF, 66.34 Kb)), relating to pharmacovigilance inspections, explains precisely how these formalities are met.

Circular 544 (PDF, 121.81 Kb) (updated following the Royal Decree of 16 March 2010, amending Articles 68 § 2 and 195 of the Royal Decree of 14 December 2006) (+ Annex (DOC, 349.5 Kb)) provides information on the application for registration as the person responsible for pharmacovigilance for medicines for human or veterinary use.

Circular 545 (PDF, 103.58 Kb) provides information concerning notification to FAMHP of the person responsible for human or veterinary pharmacovigilance by holders of a MAA or a registration of medicinal product.