The concept of Qualified person for Pharmacovigilance in the European Union (EU-QPPV) existed even before the GVP modules became effective in July 2012. However, the position gained importance in the non-EEA countries after the advent of the GVP modules. In the past decade, many regulatory agencies have come up with the requirement of a single contact person. This person may be termed as the QPPV, local responsible person (LRP), local QPPV, or responsible person for Pharmacovigilance (RPPV). In India this person is regarded as the PvOI or the Pharmacovigilance Officer In-charge. Some countries follow the concept of the local Safety Representative (LSR) for the multinational companies that have operations in multiple countries. Such companies have the option of nominating the LSR for that country. The requirements are more or less same as the local QPPV.

Global QPPV

Some regulatory agencies require the nomination of the global QPPV, who is generally the head of Global Pharmacovigilance or the EEA-QPPV. In addition, the marketing authorization holder (MAH) is expected to nominate the local responsible person who resides in that country and also knows the local language.

Requirements in Australia, New Zealand and Switzerland

In Australia, there is a concept of the Australian Pharmacovigilance Contact Person who needs to be located within the country. Besides, there is also a requirement to nominate a QPPV in Australia (QPPVA) who can be based out of any country. The MAH can consider nominating one person who is based in Australia and takes up the dual role. In New Zealand and Switzerland it is not mandatory for the responsible person (or QPPV) to be a country resident. However, this person should be contactable during the business hours of the regulatory agency.

Back-up Provisions

The QPPV is generally required to be available 24x7x365. During planned absence or during emergencies, the deputy or the back-up QPPV would need to take over the role. The back-up provisions may be missing in the regulatory guideline. However, the MAH needs to proactively nominate a back-up.

Qualifications and Experience

In Ethiopia, the person designated as QPPV is required to be a healthcare professional with at least two years’ experience in pharmacovigilance related activities. Quite a few regulatory agencies have set minimum two (2) years of experience as the criteria. In Pakistan, the QPPV is required to have a Bachelor’s degree in pharmacy or medicines and basic training in pharmacovigilance. In Oman it is desirable for the QPPV to have a basic training in epidemiology and biostatistics. Some regulatory agencies are flexible with the qualification of the QPPV provided they have two years’ experience in Pharmacovigilance. However, a QPPV who is a non-medic is required to have access to a medically qualified person. In Ghana, the QPPV is required to receive a formal training in pharmacovigilance recognized by the Authority. Besides a QPPV contract template has been put together by the FDA Ghana. Besides, there is also a separate process for re-designation of the QPPV in Ghana.

QPPV Experience Checklist

The concept of QPPV experience checklist exists in Egypt. It is a laundry list of safety aspects and the MAH needs to confirm if the proposed QPPV has practical experience in those areas.

QPPV – Contractor or Full-time?

In the EEA and UK, we can have contractor QPPVs providing service to multiple MAH’s. Some regulatory agencies mandate that the QPPV is a part of a company and not an independent contractor. In South Africa, the QPPV needs to be a Full-Time Employee of the MAH (Not a Consultant). Besides, the FDA-Ghana reserves the right to withdraw the license of any QPPV who is found to take up a full-time role with another company.

Veterinary Pharmacovigilance

A QPPV is even required for the Veterinary Medicinal Products registered in the EEA and the UK. It is convenient for the MAH if the QPPV is a Veterinary Surgeon. Else, the QPPV needs to have access to one. Besides, the back-up provisions apply here too!

Two or more QPPVs for a single MAH

Generally small companies have only one QPPV in the EEA. However large Pharma companies that have multiple Pharmacovigilance systems, may have multiple QPPVs. Such provisions exist outside the EEA as well. The general norm is one PSMF – one QPPV.