The review of buflomedil was initiated following the decision of the French regulatory authority in February 2011 to suspend the marketingauthorisation.
The basic arrangements for batch release for a product are defined by its MarketingAuthorisation. Nothing in this annex should be taken as overriding those arrangements.
成品放行在上市许可中有基本要求。本附件条款不能凌驾于上市许可之上。
3
The Qualified Person responsible for final batch certification together with the marketingauthorisation holder should ensure that the quality review is performed in a timely manner and is accurate.