Qualified person for pharmacovigilance

The qualified person for pharmacovigilance takes personal responsibility for organisation and management of the pharmacovigilance system within the company. He or she needs to be continuously available and therefore most large companies also nominate a deputy. It is essential that adequately documented procedures are put in place and that a quality management system approach is adopted. 

The fields of manufacture, control and distribution have been loaded with GMP and GDP related regulations and recommendations in order to minimise errors. These regulations require a Qualified Person (QP), or Responsible Person or Authorised Person to be involved before the product is admitted to the market. Adverse event monitoring and reporting have been subject to pharmacovigilance regulations, supervised by a Qualified Person for Pharmacovigilance (QPPV). These developments in industiy have in their turn increased attention and requirements to similar functimis in preparation in conununity and hospital pharmacies. 

Pharmacovigilance is about the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem (see Sect. 35.4.2). The Marketing Authorisation Holder of a product has to have at his disposal a qualified person who is responsible for the pharmacovigilance of that product, the Qualified Person for Pharmacovigilance (QPPV) [3]. 

In the EU, a basic requirement for marketing authorisation holders (MAHs) is that they must have permanently and continuously at their disposal a nominated qualified person, with responsibility for pharmacovigilance. This person should have experience in all aspects of pharmacovigilance and, if not the holder of a medical or veterinary qualification, they should have access to such a person. The duties of the qualified person include ... 

The qualified person responsible for pharmacovigilance or persons working for or with this person. 

This guideline lays down the roles and responsibilities of the MAH and of the national competent authorities in respect of the products authorised through the national procedures (including the mutual recognition procedure). Also defined are the roles and responsibilities of the Reference Member States (for mutual recognition products) and of the rapporteur and EMEA for centrally approved products. The role and responsibilities of the MAH include having a named, qualified person responsible for pharmacovigilance at the EU level, and there may be a need for an additional named person at the national level when this is required. 

In order to establish and maintain a pharmacovigilance system, the holder of the marketing authorization is required to have permanently and continuously at his or her disposal an appropriately qualified person. This qualified person is personally responsible for ensuring that information about all adverse reactions that are reported to the personnel of the company and to medical representatives is collected and collated. This qualified person is also responsible for ensuring that all suspected serious adverse reactions are reported to the competent authority concerned. 

Marketing authorisation holder s role and responsibilities include having a named, qualified person responsible for pharmacovigilance at the EU level, and there may be a need for an additional named person at the national level when this is required. The duties of the qualified person include ... 

Quality defects are reported often by the patient to a physician, to the pharmacist and to industry. Such complaints come to the attentirm of the QP and the Qualified Person responsible for Pharmacovigilance... 

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