MAA definition

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 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 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

• In the event that the milestone under Section 8.3.5 is skipped for any reason, then within [***] days following the first submission of an NDA or MAA for a Product, such skipped milestone shall become due and payable.

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 means an application filed with the relevant Foreign 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 has the meaning set forth in the definition of “Drug Approval Application.”

MAA means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

MAA means an EU marketing authorization application.

MAA means a marketing authorization application or equivalent application, and all amendments and supplements thereto, filed with the applicable Regulatory Authority in any country or jurisdiction. For clarity, MAA does not include any application for Pricing and Reimbursement Approval.

MAA means Marketing Authorization Application.