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  • Anon
    25/04/2017 09:14
    Dear PV Experts, I have 2 queries: 1. Do serious cases reported to the MAH by Regulatory authorities need to be followed-up and how many follow-ups are ideally to be performed and within what interval? 2. Scenario - Cases migrated from Vendor I to vendor II. For serious cases 2 FUs have to be performed as per the SOP. Some cases have been followed up once by Vendor I and then the migration takes place. In this case who is responsible for FU II..vendor I or vendor II? Thank you in advance, Anon
  • GPvP Committee
    17/05/2017 16:26
    Dear Anon 1. Most companies make a decision that cases received from the Health Authorities are not routinely followed up. However, depending on the type of medicinal product, or for example specific conditions imposed by the HA as part of the marketing authorisation, such cases initially reported to an HA may be followed up by the company. The company would define in their procedures a list of events of special interest (e.g. anaphylactic reaction) which needs to be followed-up. In addition, cases alerting to new risks or changes in the known risks, or cases notifying the death of a patient can be defined by the company as requiring follow-up. Now a second aspects needs to be considered: Whether follow-up for such company-specified cases can be conducted also depends on the data protection laws in each country, i.e. whether the contact details which were initially submitted to the HA, gave explicit permission that a Third Party (in this case the company) may contact the reporter for follow up. If a case reported initially to an HA is followed-up, most companies apply exactly the same rules as for follow-up for cases reported directly to them. Whilst for example the EMA GVP Module VI only states that “attempts” should be made, the minimum number is not detailed. Many companies specify 2-3 documented attempts for follow-up, spread across a period of 2-3 months from the initial receipt – this is different where the reporter explicitly says that they cannot provide any more follow-up information, in which case the follow-up process is stopped and the case declared “lost to follow up”. For pregnancy follow-ups, the expected delivery date, or a last known menstrual period date is used to set the week from which the 2-3 follow-up attempts would start. 2. Ideally, such a responsibility for follow-up has been detailed beforehand in the contract between Vendor I and Vendor II. If that is not the case, we would suggest (but there is no right or wrong) that Vendor II, because they now hold all the data, is responsible for follow-up in accordance with their own SOPs, or in accordance with the follow-up conditions specified in the contract with the product MAH. Vendor I, however, must still be made responsible to forward any case information which they keep receiving immediately to Vendor II. In the end, the particular responsibilities depend on the negotiations between Vendor I and Vendor II.
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