EMA: Regulatory and procedural guideline: Annex I variation application(s) content for live attenuated influenza vaccines, draft

MAHs shall submit a Type II variation application containing the adequate quality documentation in accordance with Article 18 of Commission Regulation (EC) No 1234/2008, by the Agency recommended target annual deadline, which will be published every year together with the EU Annual strain(s) recommendations. The current requirements for the content of the European application dossier are set out in Annex I to Directive 2001/83/EC, as amended.