May the marketing authorisation holder appoint multiple contact persons for pharmacovigilance issues who will be responsible for the different products in the marketing authorisation holder's portfolio?

In general, SÚKL requires a single contact person for pharmacovigilance issues for the entire portfolio of medicinal products of one marketing authorisation holder. It is recommended to check that the contact person for pharmacovigilance issues has been reported for the entire portfolio of authorised products of the marketing authorisation holder in the notifications already made.

If the marketing authorisation holder’s products are divided between two or more pharmacovigilance systems, SÚKL considers it justified for the marketing authorisation holder to nominate a contact person for pharmacovigilance issues for each pharmacovigilance system. In the case of multiple pharmacovigilance systems for products of a single marketing authorisation holder and multiple contact persons for pharmacovigilance issues, the marketing authorisation holder shall provide SÚKLwith the MFL number for each PV system and contact person in addition to the information required by the PHV-6 guideline.