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.
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MAA Filing means the validation by the EMA of a centralized filing of an MAA for the applicable Licensed Product.
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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.
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Examples of MAA Filing in a sentence

  • U.S. NDA Submission Planned for Q2 2017; EU MAA Filing Planned for Q3 2017.

  • It is understood and acknowledged that if BMS (by itself or through its Affiliates or Licensees) uses Commercially Reasonable Efforts to Develop a Product through an MAA Filing, BMS shall be deemed to be in compliance with its obligation under Section 4.1 to use Commercially Reasonable Efforts to Develop a Product with respect to all countries in the EU.


More Definitions of MAA Filing

MAA Filing means filing with the EMEA of a marketing authorization application (“MAA”) for the applicable Product under the centralized European procedure. If the centralized EMEA 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 Country.
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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 [***].
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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.
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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.
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Related to MAA Filing

  • HSR Filing means the filing of the Notification and Report Form pursuant to the HSR Act with respect to the transactions contemplated by this Agreement with the Antitrust Division of the United States Department of Justice and the United States Federal Trade Commission.

  • 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.

  • Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

  • Required Filing Date has the meaning set forth in Section 3.1.

  • Marketing Authorization Application or “MAA” means a Marketing Authorization Application, Biologics License Application or similar application, as applicable, and all amendments and supplements thereto, submitted to the FDA, or any equivalent filing in a country or regulatory jurisdiction other than the U.S. with the applicable Regulatory Authority, to obtain marketing approval for a pharmaceutical or diagnostic product, in a country or in a group of countries.

  • Filing means the receipt under this chapter of a record by the administrator or a designee of the administrator.

  • Regulatory Submissions means any filing, application, or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • SEC Filings has the meaning set forth in Section 4.6.

  • Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Regulatory Authority.

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Licensed Product in a country.

  • Joint Proxy Statement has the meaning set forth in Section 6.03(a).

  • Regulatory Authorities means, collectively, the Federal Trade Commission, the United States Department of Justice, the Board of the Governors of the Federal Reserve System, the Office of Thrift Supervision (including its predecessor, the Federal Home Loan Bank Board), the Office of the Comptroller of the Currency, the Federal Deposit Insurance Corporation, all state regulatory agencies having jurisdiction over the Parties and their respective Subsidiaries, the NASD and the SEC.