[Jen Rose]

Reply To: Sponsor address change for IMP labels

Hi – I echo the other responses but will also add a little more detail.

Be aware the agency in each country will need to be notified and each will have different requirements. My experience is most countries will allow your current label to be grandfathered for a period of time but there will be an expectation to have all of your supplies transitioned to a new label at some point in time. The agencies may expect the new sponsor to specify a date by which all new supplies entering the field will reflect the new sponsor’s details and not allow you to just leave it open ended. Some countries may also expect supplies with the prior sponsor details be removed from the field by the same date. Ideally the new sponsor organization, and not the agency, will define the transition date based on when you can realistically make the transition. Defining that date will require developing a solid manufacturing/labeling/distribution plan for the new materials before making the proposal to each agency. There will be other clinical trial documentation that needs amending to reflect the new sponsor and hopefully your regulatory team can support communication to the agencies regarding your IP labeling strategy along with all else that will need to be agreed upon by each agency.

There is no one size fits all solution. What I’ve shared above is based on what I’ve encountered in the past and worked for me. Hope this info helps you sort out a path that will work for your situation. Good luck!