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 reporting healthcare professional.
If the MAH is of the opinion that it is necessary to request follow-up information, an email should be sent to email@example.com containing the following:
- A written request for follow-up information, structured in a questionnaire in Norwegian language.
- 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 questionnaire should not contain 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 firstname.lastname@example.org.