MAA Approval definition
MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.
MAA Approval means, with respect to a particular Product, the Approval of an MAA by the EMA for such Product in any European Union country or other country in Europe.
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
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.
More Definitions of MAA Approval
MAA Approval shall be achieved upon receiving Regulatory Approval of an MAA and, where applicable, receipt of pricing and reimbursement approvals, for the applicable Product in a Major European Country.
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 the Approval of an MAA by the EMA for a Product in any country in the EU.
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 the grant of a marketing authorization by the European Commission for a Product in the European Union.
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 three of the following countries: France, Germany, Italy, Spain and the United Kingdom.