Adverse Events reports from MAH for human medicinal products

New pharmacovigilance legislation will come into effect 2 July this year.

16.5.2012

When the new pharmacovigilance legislation will come into effect 2 July this year the Holder of a Marketing Authorisation is required to report:
  • All Serious non-EEA cases related to medicinal products authorised in Iceland to the Eudravigilance database. The MAH is not required to send a copy to IMA or to his agent in Iceland.
  • All Non-serious EEA cases occurring in Iceland should be reported to IMA until it is possible to report these ADRs to Eudravigilance. The MAH will not be required to send a copy to IMA from the date it is possible to report these ADRs to Eudravigilance database

EMA's guidelines to the reporting of individual Case Safety Reports (ICSRs) during the interim period.

A national Quality Person responsible for pharmacovigilance, QPPV.

The IMA does not require the Holder of the MA to appoint a national QPPV residing in Iceland.