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null What is the procedure for follow-up information requests (from the MAH) for reports reported to the EudraVigilance database by Fimea?

What is the procedure for follow-up information requests (from the MAH) for reports reported to the EudraVigilance database by Fimea?

The procedure regarding follow-up information is as described in GVP module VI* chapter VI.C.2.2. Responsibilities of the marketing authorisation holder in the EU:

For the ICSRs made accessible to a marketing authorisation holder from the EudraVigilance database in accordance with Article 24(2) of Regulation (EC) No 726/2004 and in line with the EudraVigilance Access Policy for Medicines for Human Use24, the routine request for follow-up by the marketing authorisation holder is not foreseen. If the follow-up of an ICSR is necessary for a specific situation, a justification should be provided with the request, which should be addressed directly to the sender organisation of the ICSR.

* Guideline on good pharmacovigilance practices (GVP) Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2)

Fimea will assess the need for follow-up information for each ICSR, and contact the reporter if needed. The MAH shall not routinely ask for follow-up information via Fimea. In situations listed below no follow-up information is routinely requested from the reported, unless assessed necessary:

  • information that has already been requested on the initial report form: for example symptoms and/or diagnosis, test results, and medical history
  • medical confirmation for consumer reports
  • follow up information which it is presumably not available to the reporter: e.g. laboratory test results for a case reported by a pharmacist
24 Jan 2018