www.fdanews.com/articles/169332-ema-consolidates-requirements-for-flu-vaccine-submissions
EMA Consolidates Requirements for Flu Vaccine Submissions
December 26, 2014
Manufacturers of pandemic flu vaccines will have more leeway in what they submit to the European Medicines Agency, according to final guidance that consolidates the requirements for premarket submissions for all types of influenza vaccines.
International Pharmaceutical Regulatory Monitor