The fresh new PSUR is not the suitable means of submitting last or meantime investigation account with the Eu regulatory authorities. Last research profile would be submitted and you may assessed through the suitable procedure based on the recommendations to your details of the new certain kinds of variations, towards surgery of your steps applied off within the Sections II, IIa, III and you will IV from Commission Regulation (EC) No . For centrally authorised products interim research accounts maybe not impacting to the equipment guidance otherwise towards updates as stated throughout the Annex II of sales authorisation would be registered given that a post-authorisation measure (PAM) once the demonstrated concerned Just how also to which will I fill in my personal PAM data (find Blog post-authorisation actions: questions and you can solutions)?. Continue reading “21. What are the timelines to your submitting from PSURs?”