[David Adams]

Reply To: Grace period for label changes

My Quality and Regulatory Teams have actually told our Clinical Supply Team there is no need to proactively re-label IP that has already been QP released. As long as the packaged IP has been QP released for a country before the full submission of EU CTR Part I documents are approved, you can still ship your IP with EudraCT # (approved under CTD) to clinical sites.