Does the marketing authorisation holder have to notify SÚKL of a contact person for pharmacovigilance issues even if none of the medicinal products authorised in the Czech Republic are marketed in the Czech Republic?

Yes, the obligation to notify SÚKL of a contact person for pharmacovigilance issues applies to all marketing authorisation holders, regardless of whether their products are currently marketed in the Czech Republic or not. For a new marketing authorisation holder who has not yet registered any product in the Czech Republic, the obligation applies from the approval of the marketing authorisation. Exceptions cannot be granted.