MAH/QP/QPPV Requirements - Overview
European manufacturers and Marketing Authorization Holders (MAHs) of medicinal products have various responsibilities. For example, to execute the batch release process and to perform the legal requirements related to Pharmacovigilance, MAHs must identify suitable individuals to perform the roles of Qualified Person (QP) and Qualified Person responsible for Pharmacovigilance (QPPV).
Many other activities undertaken by the MAHs require the support of a QP to meet the requirements of Health Authorities (HAs) throughout the European region. For example, the advice of a QP can be valuable in mergers or acquisitions to ensure all relevant quality aspects are considered.
The QPPV acts as a single point of contact for HAs for product safety-related topics. The responsibilities include establishing and maintaining the Pharmacovigilance system, ensuring the safety profiles of the company’s medicinal products are kept up-to-date, and meeting legal obligations on the reporting of safety concerns. As part of the Pharmacovigilance system, the MAH shall have an appropriate Qualified Person (QP) responsible for Pharmacovigilance in the EU (EU QPPV) [DIR Art 104(3)(a)], at its disposal. The MAH shall submit the name and contact details of the QPPV to the competent authorities in the Member States and the Agency [DIR Art 104(3) last paragraph]. Changes to this information should be submitted per Regulation (EC) No 1234/2008 on variations to the terms of the marketing authorization.
In addition to the QPPV, competent authorities in the member states are legally provided with the option to request the nomination of a Pharmacovigilance contact person at the national level who reports to the QPPV. Reporting, in this context, relates to Pharmacovigilance tasks and responsibilities and not necessarily to line management. A contact person at the national level may also be nominated as the QPPV. Overall, the MAH should ensure that structures and processes are in place so the QPPV can fulfill its responsibilities. In the UK, companies need to make sure that they meet specific obligations that will apply to the provisions of QPPV services following the end of the Brexit transition period.
Freyr, through its comprehensive resources, can provide end-to-end MAH services and act as a local representative and can assist in providing QPPV services along with end-to-end Regulatory strategic consulting.
MAH/QP/QPPV Requirements - Expertise
- Single point of contact for QPPV, adverse event reporting, signal detection & evaluation, and other Pharmacovigilance services.
- Support in the appointment of a Qualified Person (QP), Qualified Person responsible for Pharmacovigilance (QPPV), and National Person for Pharmacovigilance (NPPV) in all the EU countries.
- Track safety variations and PV system master file compliance.
- Brexit-related Regulatory support, including assistance with market entry for companies without an approved product in the EEA or UK, QP changes, Pharmacovigilance System Master File (PSMF), EU QPPV requirements, etc.
- Market authorization procedures (i.e., Centralized, MRP, DCP, and National)
- Acquiring submission slots from HA.
- Compilation, review, and submission of Market Authorization Application (MAA) - Article 10(1).
- Legal representation as Marketing Authorization Holders (MAHs) for medicinal product manufacturers without establishments in the European Economic Area (EEA).
- Regulatory experts with a comprehensive understanding of HA requirements.
- Lifecycle management of medicinal products, including MA license renewal.
