Responsibilities of the marketing authorization holder concerning the qualified person responsible for pharmacovigilance (QPPV) in the EU
20 april 2023
In the European Union (EU), a medicinal product marketing authorization holder (MAH) ensures that the product is safe and effective. As part of this responsibility, the MAH must appoint a qualified person responsible for pharmacovigilance (QPPV) per EU regulations to ensure the product’s safety is monitored and any potential risks are identified and managed appropriately.
The QPPV plays a critical role in ensuring the safety of medicinal products. They are responsible for the pharmacovigilance system, which includes monitoring adverse drug reactions, the management of risk assessment and risk minimization activities, and providing information on the safe use of medicinal products.
The responsibilities of the MAH in relation to the QPPV are set out in the EU pharmacovigilance legislation, which requires the MAH to ensure that the QPPV is:
Appointing a QPPV
The MAH must appoint a QPPV responsible for the pharmacovigilance system for each medicinal product authorized in the EU. The QPPV must have the qualifications and experience to carry out their duties effectively.
Ensuring adequate resources
The MAH must ensure that the QPPV has the necessary resources, including personnel, systems, and equipment, to carry out their duties effectively. The MAH must also ensure that the QPPV has access to relevant information, such as data on adverse drug reactions and risk assessment reports.
Maintaining the pharmacovigilance system
The MAH must ensure that the pharmacovigilance system is maintained and complies with EU regulations. This includes providing the QPPV has the authority and resources to carry out its duties effectively.
Ensuring compliance
The MAH must ensure that the QPPV complies with EU regulations and guidelines relating to pharmacovigilance. This includes ensuring that the QPPV is aware of changes to regulations and guidelines and implementing any changes required to the pharmacovigilance system.
Reporting adverse drug reactions
The MAH is responsible for reporting adverse drug reactions to the relevant authorities in the EU. The QPPV oversees this process and reports all relevant information promptly.
Conducting risk assessments
The QPPV is responsible for conducting risk assessments for medicinal products and implementing risk minimisation measures where necessary. The MAH must ensure that the QPPV has the resources to carry out these activities effectively.
Providing information
The QPPV is responsible for providing information on the safe use of medicinal products to healthcare professionals and patients. The MAH must ensure the QPPV has the necessary resources to carry out this activity effectively.
Importance of MAH Responsibilities for Ensuring the Safety of Medicinal Products in the EU
The MAH is also responsible for ensuring that the QPPV has access to all relevant information on the product’s safety, including adverse reactions, clinical trials, and post-approval studies. The MAH must also ensure that the QPPV is involved in the product’s development from an early stage and fully understands its safety profile.
In conclusion, the responsibilities of the MAH in relation to the QPPV are critical for ensuring the safety of medicinal products placed on the market in the EU. The MAH must ensure that the QPPV has the necessary resources to carry out its duties effectively, including maintaining the pharmacovigilance system, reporting adverse drug reactions, conducting risk assessments, and providing information on the safe use of medicinal products. By fulfilling these responsibilities, the MAH can ensure that medicinal products are safe and effective for patients in the EU.
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