It would be a simple alignment, the same as what they have with the FDA in the U.S. When the clinical trial protocol is approved, it automatically gets open label extension, unless there has been an adverse event or something to signal safety issues associated with it. There should be no reason that a separate application has to go through for an open label extension once the clinical trial protocol has been met. It seems like a simple solution. I'm not certain.
On September 27th, 2018. See this statement in context.