If the QPPV or RP changes within an organisation, the organisation must nominate a new QPPV or RP within 10 calendar days. The existing QPPV/RP cannot be removed from EudraVigilance until their replacement is registered, and registration documents for the newly appointed QPPV/RP need to be included.
No, the information on the deputy QPPV is not within the required information to be included in the summary of the applicant's pharmacovigilance system, as per Article 8(3)(ia) of Directive 2001/83/EC. According to the legislation and guidance in GVP Module I, 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).
Therefore back-up procedures in case of absence of the QPPV shall be in place. The QPPV should ensure that the back-up person has all the necessary information to fulfil the role. The information relating to the QPPV provided in the PSMF shall include details of back-up arrangements to apply in the absence of the QPPV.
Yes; One MAH can have more than one QPPV in EU/EEA
Upon a change in the QPPV or location of the PSMF information, the Article 57 database shall be updated by the marketing authorisation holder immediately and no later than 30 calendar days, in order to have the information in the Article 57 database and on the European medicines web-portal referred to in Article 26(1) of Regulation (EC) No 726/2004 updated and to allow continuous supervision by the competent authorities.
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Spain,
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Slovakia,
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Romania,
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France,
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Portugal,
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Poland,
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Belgium,
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Netherlands,
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Lithuania,
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Latvia,
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Hungary,
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Germany - Stufenplanbeauftragter,
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Greece,
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Denmark,
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Croatia,
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Cyprus,
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Czech, and
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Bulgaria
If the EEA QPPV is resident of any of these countries then a separate local QPPV would not be required if the EEA QPPV speaks the local language.