PVAs – Shared Procedures

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    Elena Snidal
    Participant

    Dear Colleagues,
    I was wondering if anyone has any experience or advice in relation to PVAs between MAHs in the RMS and CMS for shared procedures (DCP or MRP procedures)? What are the expected responsibilities of each party? As a PV provider, we have a client who is the MAH in the RMS (the Netherlands) in a Shared Procedure with an MAH in the CMS (Poland). Are you aware of any specific requirements for sharing of safety information between the two parties? Also are you aware of inspector expectations in this regard?
    The reason we are asking is that our client MAH in the RMS territory of the Netherlands has recently been declined the opportunity to conduct audit of the MAH in the CMS territory of Poland. The MAH in the CMS has subsequently requested major revisions to the PVA including that audits would only be required if suspected breach of terms of the PVA (not routinely), each MAH being responsible for their own PSURs (rather than the RMS submitting a PSUR on behalf of both companies) and no regular exchange of ICSRs. We wanted to check if this is in line with legislative requirements and/or your experiences to date.
    Any guidance, experiences or advice you can provide would be very much appreciated.

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