Adverse Events reports from MAH for human medicinal products
New pharmacovigilance legislation will come into effect 2 July this year.
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
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.