The marketing authorisation holder may request a position statement in advance or seek preliminary information regarding the future procedure. Questions concerning additional risk minimisation tools/programmes may be submitted to farmakovigilancia@nngyk.gov.hu. The marketing authorisation holder will receive written information from the NNGYK.
Where possible, the information provided will be based on the detailed guidance on additional risk minimisation measures available on the NNGYK website. In the case of a request for a position statement, the marketing authorisation holder will receive a response from the NNGYK within 10 days.
