MAA Filing definition
MAA Filing means validation by the EMA of the filing of a Marketing Authorization Application for the applicable Product under the centralized European procedure, as demonstrated by the start of the procedure under the timetable adopted by the Committee for Medicinal Products for Human Use (CHMP). If the centralized EMA filing procedure is not used, MAA Filing will be achieved upon the first filing of an MAA for the applicable Product in any Major European Countries.
MAA Filing means the validation by the EMA of a centralized filing of an MAA for the applicable Licensed Product.
MAA Filing means the submission to the EMEA of a MAA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Filing shall be achieved upon the first filing of a marketing authorization application for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.
More Definitions of MAA Filing
MAA Filing means the validation by the EMA of the filing of an MAA for the applicable Licensed Product. If the centralized EMA filing procedure is not used, MAA Filing shall be achieved upon [***].
MAA Filing means the filing of a marketing authorization application or other application for marketing approval for the applicable Product filed (a) in [**] or (b) in the European Medicines Evaluation Agency under the centralized European procedure.
MAA Filing means receipt by GSK of written notice of acceptance by the EMEA of an MAA for filing under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Filing shall be deemed to be achieved, for purposes of Section 8.2.2, upon the acceptance of a marketing authorization application with the Regulatory Authority in a Major EU Country.