MAA definition
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.
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.
Examples of MAA in a sentence
Legend will [***] cooperate with Novartis in the preparation of any response thereto to Regulatory Authorities and any mutually agreed corrective action plans which could reasonably be expected to affect Legend’s Data Integrity or be considered critical findings regarding any IND, MAA or other Regulatory Materials relevant to [***].
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 requisite Regulatory Agency of any jurisdiction in the Territory requesting Regulatory Approval authorizing the commercial sale of a Product for a particular Indication in such jurisdiction.
MAA has the meaning set forth in the definition of “Drug Approval Application.”
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 means an EU marketing authorization application.
MAA means a regulatory application filed with the EMA or MHLW seeking Regulatory Approval of a Licensed Product, and all amendments and supplements thereto filed with the EMA or MHLW.
MAA means (a) a New Drug Application in the United States, as defined in the United States Federal Food, Drug and Cosmetics Act, and applicable regulations promulgated thereunder by the FDA, (b) a Biologics License Application in the United States, as defined in the United States Public Health Service Act, or (c) any application filed with any Regulatory Authority in a country other than the United States that is equivalent to either of the foregoing.