October 18, 2021
QPPV Outsourcing in EU/EEA and its benefits for MAH
To place its medicines on the market in the European Union (EU) and the European Economic Area (EEA), the Marketing Authorization Holder (MAH) must designate a person responsible for pharmacovigilance (EU-QPPV) as a necessary regulatory requirement. The EU-QPPV ensures that all legal requirements for MAHs related to monitoring a medicinal product in the market are met concerning pharmacovigilance. This expert must reside within the EU or EEA and should be permanently and continuously at the disposal of the MAH.
The primary responsibilities of the EU-QPPV are:
- Establishing and maintaining the MAH’s; pharmacovigilance system;
- Acting as a single point of contact for the competent authorities in the Member States and the European Medicines Agency for a 24-hour basis;
- Acting as a contact person during pharmacovigilance inspections;
- Monitoring and reviewing the safety profiles of medical products and other emerging safety concerns;
- Ensuring conduct of pharmacovigilance and submission of all pharmacovigilance-related documents following the legal requirements and GVP; They ensure and verify that the Pharmacovigilance System Master File (PSMF) is constantly up-to-date and reflects the current pharmacovigilance system.
These are the most important but not all of the requirements and responsibilities that apply to EU-QPPV. Detailed information on the role and responsibilities of the EU-QPPV is listed in the Guideline of good pharmacovigilance practices (GVP; Module I – Pharmacovigilance systems and their quality systems).
Why outsource the EU-QPPV function to a service provider?
The MAH often faces a shortage of in-house experts and professional expertise to develop and maintain a pharmacovigilance system for medicinal products in the EU / EEA countries.
EU-QPPV is an expert with leadership qualities, in-depth pharmacovigilance knowledge, and solid experience in the field. Foreseeing, analytical thinking, and efficient decision-making helps develop and manage effective PV systems. In this way, outsourcing the EU-QPPV function to a service provider allows the MAH to delegate most legal PV responsibilities and focus internal resources on product commercialisation, market access, and other business development areas.
Benefits of outsourcing QPPV function to a service provider:
Excellent expertise and deep knowledge of PV activities. Proper management of the pharmacovigilance system requires highly competent experts and an appropriate level of knowledge that often lacks the MAH in-house. These gaps are filled by the service providers, as they have experience with pharmacovigilance projects of various sizes and types and can therefore manage pharmacovigilance systems globally to meet the required requirements competently, adequately, and promptly.
- Cost-effective choice
The outsourcing option may save extra costs for pharma companies. In particular, the employment of a person full-time within a company requires the payment of significant taxes and his salary and workspace cost. As a further remark, it is worth noting that it is not worthwhile for the MAH to hire a full-time QPPV, as these competent persons do not engage in the day-to-day technical activities of the PV and are mainly responsible for the oversight and management activities of the PV department. In other words, the MAH does not need a full-time QPPV, as they overpay in terms of the time spent on its services. That is why QPPV services are often outsourced from service providers as they ensure QPPV workload distribution by providing services to multiple MAHs, thus achieving the cost-effectiveness of QPPV and saving costs for the marketing authorization holder.
Marketing authorisation holders must ensure an adequate local pharmacovigilance function in the various countries. As part of these local legal requirements, some countries require MAHs to nominate the so-called Local Qualified Persons for Pharmacovigilance (Local QPPVs) or Local Persons for Pharmacovigilance (LPPVs). To address this need, along with EU QPPV services, some service providers ensure the possibility to the MAH to outsource the local QPPV or LPPV functions. Delegating these PV functions to a single partner provides MAH with a single interface for oversight and compliance monitoring regionally (EU) and country-wise.
- Ability to adapt to pharmacovigilance needs
Outsourcing needs may also vary depending on the size of the pharmaceutical company and their stage of the medicinal product life-cycle. PV services are often outsourced to small pharmaceutical companies seeking their first marketing authorisation in the EU market. In many cases, the EU-QPPV function is outsourced by companies whose headquarters are outside the EU / EEA, i.e companies based in the US and who require PV support in the region. Such companies will certainly need both pharmacovigilance system and QPPV service as it is mandatory to have PSMF, nominated EU-QPPV and Eudravigilance registration before the submission for marketing authorisation in the EU/EEA.
At Insuvia, we have our processes adapted explicitly to clients needs to provide small and mid-sized pharmaceutical companies with a cost-effective full-service safety department as an outsourced solution. Led by in-house QPPVs and a team of experienced pharmacovigilance professionals, Insuvia supports MAH with oversight and management of QPPV services:
- Provision of QPPV office, including EU QPPV and Deputy QPPV, Medical Team;
- Provision of Local Persons for Pharmacovigilance (Local QPPVs & LPPVs) and Deputies;
- Provision and production of Pharmacovigilance System, Pharmacovigilance System Master File (PSMF) and regional Sub-Files.