[Loretta Cipkus Dubray]

Reply To: Annex VI subject ID/treatment number = kit ID?

Per the Annex 6 of the Regulation (EU) No 536/2014, the subject identification number/treatment number and where relevant, the visit number are mandatory particulars to be included on the label.

However, in case client can justify that a Kit ID covers the requirement of the subject identification number/treatment number in the clinical documentation (i.e. client keeps track of which kit ID is administered to each patient), this should be a sufficient solution.