Manufacturers and Marketing Authorisation Holders (MAHs) of medicinal products in the European region have important responsibilities. For example, to execute the batch release process and to perform the legal requirements related to pharmacovigilance, Marketing Authorisation Holders (MAHs) must ensure that they have identified suitably qualified 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 in order to meet the requirements of health authorities in countries throughout the European region. For example, the advice of a QP can be valuable in case of mergers or acquisitions to ensure all relevant quality aspects are considered.
The QPPV acts as a single point of contact for Health Authorities covering product safety-related topics. The responsibilities include establishing and maintaining the pharmacovigilance system, ensuring product 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 marketing authorisation holder shall have an appropriately qualified person (QP) responsible for pharmacovigilance in the EU (EU QPPV) [DIR Art 104(3)(a)], permanently and continuously at its disposal . The marketing authorisation holder 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 in accordance with Regulation (EC) No 1234/2008 on variations to the terms of marketing authorisation.
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 national level reporting 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 marketing authorisation holder should ensure that structures and processes are in place so that the QPPV can fulfil the responsibilities. In the UK, companies need to make sure that they meet specific obligations that will apply regarding the provisions of QPPV services following the end of the Brexit transition period.
Freyr, through its comprehensive resources, can act as Market Authorisation Holder (MAH), local representative and can assist in providing QPPV services, along with end-to-end Regulatory strategic consulting.
Single point of contact for QPPV, adverse event reporting, signal detection and evaluation and other pharmacovigilance services
Support in the appointment of Qualified Person (QP), Qualified Person for Pharmacovigilance (QPPV), 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 a currently approved product in the EEA or UK, QP changes, Pharmacovigilance system master file (PSMF) and EU QPPV requirements, etc.
Market authorization procedures (i.e., Centralized, MRP, DCP, National)
Acquiring submission slots from HA
Compilation, review and submission of Market Authorization Application (MAA) - Article 10(1)
Legal representation as Marketing Authorisation Holders (MAH) for medicinal product manufacturers without establishments in the EEA
Regulatory experts with comprehensive understanding of health authority requirements
Lifecycle management of medicinal products, including MA license renewal