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Procedure for follow-up information requests for adverse reaction reports

Published:

Changes

The routine request for follow-up information by the marketing authorisation holder (MAH) to an adverse reaction report/ICSR received from NOMA should be limited.

According to the GVP module VI, section VI.C.2.2. the routine request for follow-up information by the MAH on reports received from the authorities is not foreseen.

However, in some cases, it might be relevant and necessary for pharmacovigilance purposes and patient safety to obtain follow-up information. A situation where this is relevant, is when this is a requirement in the Risk Management Plan (RMP) of the suspect drug. The Norwegian Medicines Agency (NOMA) will decide if the request for information is relevant on a case-by-case basis. This is to avoid unnecessary workload for the reporter.

If the MAH is of the opinion that it is necessary to request follow-up information, an email should be sent to adr@noma.no containing the following:

  • A written request for follow-up information, 
    • When reporter is healthcare personnell, the questions should be structured in a questionnaire in Norwegian language.
    • When reporter is patient: questions must be structured in  clean text (for example rich text format) in Norwegian language. The questions must be formulated in such a way that they are comprehensible to the patient, it should not be necessary to have clarifying communication with the patient
  • A specific justification on why request for follow-up information is necessary.
  • Documentation supporting the justification, for instance the Risk Management Plan (RMP) or parts of the RMP with a clear reference to the relevant section in the document.

The questions should not ask the reporter for information already included in the original adverse reaction report and the questions should be ready to be sent to the reporter without amendments.

NOMA receives a large number of requests for follow-up information. MAH will receive feedback on their requests as soon as possible.

Questions? Please contact adr@noma.no.

Contact us

Unit for better use of medicines

+47 22 89 77 00

adr@noma.no