As part of the pharmacovigilance system, the Marketing Authorisation Holder shall have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance in the EU (QPPV). The QPPV should be appropriately qualified and shall reside and operate in the EU or in Norway, Iceland, or Liechtenstein, following European Economic Area (EEA) agreements.

The QPPV shall be responsible for the establishment and maintenance of the marketing authorisation holder’s pharmacovigilance system and therefore shall have sufficient authority to influence the performance of the quality system and the pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements. Hence, the QPPV should have access to the Pharmacovigilance System Master File (PSMF) and be in a position of authority to ensure and verify that the information contained in the PSMF is accurate and up-to-date reflection of the pharmacovigilance system under the QPPV’s responsibility.

Regarding the medicinal products covered by the pharmacovigilance system, the QPPV responsibilities include:

               - having an overview of medicinal product safety profiles and any emerging safety concerns

               - having awareness of any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety or the safe use of the products

               - having awareness of risk minimisation measures

               - being aware of and having sufficient authority over the content of risk management plans

               - being involved in the review and sign-off of protocols of post-authorisation safety studies (PASS) conducted in the EU or pursuant to a risk management plan agreed in the EU

               - having awareness of PASS requested by a competent authority including the results of such studies

               - ensuring the conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and GVP

               - ensuring the necessary quality, including the correctness and completeness, of pharmacovigilance data submitted to the competent authorities in Members States and the Agency

               - ensuring a full and prompt response to any request from the competent authorities in Members States and from the Agency for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product

               - providing any other information relevant to the benefit-risk evaluation to the competent authorities in Members States and the Agency

               - providing input into the preparation of regulatory action in response to emerging safety concerns (e.g., variations, urgent safety restrictions, and communication to patients and healthcare professionals)

               - acting as a single pharmacovigilance contact point for the competent authorities in Member States and the Agency on a 24-hour basis and also as a contact point for pharmacovigilance inspections

The QPPV may delegate specific tasks, under supervision, to appropriately qualified and trained individuals, for example, acting as safety experts for certain products, provided that the QPPV maintains system oversight and overview of the safety profiles of all products. This delegation should be documented.

Reference: Guideline on good pharmacovigilance practices (GVP), Module I – Pharmacovigilance systems and their quality systems (EMA/541760/2011)

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