04. Are Marketing Authorisation Holders required to have a Qualified Person for PharmacoVigilance (QPPV) residing in Iceland?

The requirement in Iceland has not changed. There is not a requirement for a local contact person for pharmacovigilance/local QPPV. There is only a requirement for a QPPV which resides within the European Economic Area (EU country, Norway or Iceland). This is in accordance with regulation 545/2018. The same information is provided in the list by EMA i.e. that the contact person for pharmacovigilance/QPPV must reside within any of the EEA countries.