MAA Approval means the Approval of an MAA by the EMA for a Product in any country in the EU.

MAA Approval means approval by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.

Examples of MAA Approval in a sentence

The GDP shall set forth the timeline and details (including line of therapy, tumor type, primary endpoints, approximate patient size, combination agents and comparator agents) of all preclinical and clinical Development activities to be conducted by the Parties as necessary to generate Data sufficient to meet the common requirements of both the EMA and FDA for MAA Approval of the Compound and Products for RCC, HCC, and other indications agreed upon by the Parties.
For the purpose of this Section 15.3(a), if EMA conditions such MAA Approval on the performance of additional Phase 3b or other studies, then EMA shall not be deemed to have refused the approval of such MAA.
VIVUS may terminate this Agreement on a country-by-country basis on thirty (30) days notice if MAA Approval has not been received in such county within four (4) years from the Effective Date; provided such notice is given prior to obtaining such MAA Approvals.
Where sufficient flight operations experience cannot be vested in one person, multiple flight operations post-holders may be nominated, each requiring MAA Approval for their intended role.36.
For the purpose of this Section 14.3(a), if the PMDA grants such MAA Approval conditioned on the performance of additional Phase 3b or other studies, then the PMDA shall be deemed to have granted approval of such MAA.

More Definitions of MAA Approval

MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the applicable country or jurisdiction, but excluding any pricing and/or reimbursement approval.

MAA Approval means, with respect to a particular country in the TERRITORY, approval by the applicable REGULATORY AUTHORITIES in such country of an MAA filed in such country, permitting PRODUCT to be marketed in that country for the indication(s) for which approval is sought, including, if applicable, approval of pricing or reimbursement.

MAA Approval means Approval by the EMA of a MAA filed with the EMA for the applicable Licensed Product under the centralized European procedure. If the centralized EMA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in three of the following countries: France, Germany, Italy, Spain and the United Kingdom. For clarity, MAA Approval shall include any pricing and reimbursement approvals required prior to sale of such Licensed Product in the European Union, or in connection with Approvals achieved in three of the foregoing five European Union member states; provided, that MAA Approval shall in any event be deemed achieved upon First Commercial Sale in any country in the European Union.

MAA Approval means, with respect to a Product in Europe, approval of the MAA from the applicable Regulatory Authority in at least three Core European Countries sufficient for the manufacture, distribution, use, marketing and sale of such Product and either (x) pricing and reimbursement approval in such three Core European Countries in accordance with Applicable Laws has been obtained, or (y) the sale of a Product in such three Core European Countries has occurred.