Our company is applying for a marketing authorisation (it does not hold any registration in the Czech Republic yet). When is it required to report a contact person for pharmacovigilance issues to the State Institute for Drug Control (SÚKL)?

Only the marketing authorisation holder is required to notify the contact person for pharmacovigilance issues. Reporting of the information prior to obtaining the first marketing authorisation in the Czech Republic is not desirable as the applicant may not yet be registered in the linked SÚKL systems, and the information cannot be correctly recorded.