MAA definition

MAA means a Marketing Authorization Application, in relation to any Product, filed or to be filed with the EMA (or equivalent national agency), for authorization to place a medicinal product on the market in the European Union (or any other territory).
MAA means a marketing authorization application filed with (a) the EMA under the centralized EMA filings procedure or (b) if the centralized EMA filing procedure is not used, a Regulatory Authority in any country in the EU.
MAA means an application for the authorization to market any Product in any country or group of countries outside the United States, as defined in the applicable laws and regulations and filed with the Governmental Authority of a given country or group of countries.

Examples of MAA in a sentence

  • We are also continuing to pursue full BLA and MAA approvals for Gohibic (vilobelimab).


More Definitions of MAA

MAA or “Marketing Authorization Application” means an application for Regulatory Approval for a Product in a country or region of the Territory.
MAA has the meaning set forth in the definition of Drug Approval Application.
MAA means an application filed with the relevant Regulatory Authorities in Europe seeking Regulatory Approval to market and sell any Licensed Product in Europe or any country or territory therein for a particular Indication within the Field.
MAA means an application for Regulatory Approval in a country, territory or possession.
MAA means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.